UNIVERSITY OF MIAMI TISSUE BANK ALLOGRAFT TISSUE
Transcription
UNIVERSITY OF MIAMI TISSUE BANK ALLOGRAFT TISSUE
UNIVERSITY OF MIAMI TISSUE BANK ALLOGRAFT TISSUE CATALOGUE first in Quality first in Service 1-888-684-7783 [email protected] Table of Contents Allograft Information………………………………………………………………………………………….3 General Information…………………………………………………………………………………….3 Statement from UMTB’s Medical Director ………………………………………………………………..4 University of Miami Tissue Bank (UMTB) ………………………………………………………………...4 Not for Profit Organization …………………………………………………………………………….6 Medical Personnel ……………………………………………………………………………………...6 Licenses and Accreditations …………………………………………………………………………..6 Laboratory Screening ………………………………………………………………………………………..7 Human Immunodeficiency Virus (HIV) ……………………………………………………………….7 Hepatitis B (HBV) and Hepatitis C Virus (HCV) ………………………………………………….....7 Human T Cell Lymphotrophic Virus I/II ………………………………………………………………7 Syphilis ………………………………………………………………………………………………….7 Tissue Preservation, Storage, Transit and Reconstitution ……………………………………………7 Fresh …………………………………………………………………………………………………….7 Fresh Frozen ……………………………………………………………………………………………8 Cryopreservation ……………………………………………………………………………………….9 Freeze Dried/ Lyophilized ……………………………………………………………………………10 General Orthopedics – Trauma and Reconstruction ……………………………………………...11-37 Radius…………………………………………………………………………………………………..11 Ulna……………………………………………………………………………………………………..12 Tibia Plate/Strut………………………………………………………………………………………..13 Proximal Tibia………………………………………………………………………………………….14 Tibia Segment/Tibia Shaft…………………………………………………………………………….15 Femur Condyle w/o Cartilage………………………………………………………………………...16 Distal Femur w/ Condyles .…………………………………………………………………………...17 Femur Head …………………………………………………………………………………………...18 Femur Plate (Strut) ……………………………………………………………………………………19 Proximal Femur ……………………………………………………………………………………….20 Femur Shafts & Segments …………………………………………………………………………...21 Fibular Shafts & Segments …………………………………………………………………………..22 Humerus Shafts & Segment………………………………………………………………………… 23 Proximal Humerus w/ Soft Tissue …………………………………………………………………..24 Cancellous Crushed 2-10mm………………………………………………………………………...25 Cancellous Cubes 4-10mm ………………………………………………………………………….26 Cancellous Powder 100-200m ………………………………………………………………………27 Cancellous Morselized 1-4mm……………………………………………………………………….28 Cortical Morselized 1-4mm....………………………………………………………………………...29 Cortical Cancellous Morselized ……………………………………………………………………..30 Cortical Powder 100-200m …………………………………………………………………………..31 Femur Head ……………………………………………………………………………………………32 Osteotomy Wedge …………………………………………………………………………………….33 Metacarpal ……………………………………………………………………………………………..34 Metatarsal ……………………………………………………………………………………………...35 Rib Cartilage …………………………………………………………………………………………..36 Fascia …………………………………………………………………………………………………..37 Page 2 of 68 Sports Medicine…………………………………………………………………………………………..38-50 Meniscus w/ Block …………………………………………………………………………………….38 Meniscus w/ Plateau ………………………………………………………………………………….39 Femur Condyle ………………………………………………………………………………………..40 Achilles …………………………………………………………………………………………………41 Anterior Tibialis Tendon ………………………………………………………………………………42 Posterior Tibialis Tendon …………………………………………………………………………….43 Peroneus Longus Tendon ……………………………………………………………………………44 Semitendinosus & Gracilis …………………………………………………………………………...45 Patellar Bone Tendon Bone – Half ………………………………………………………………….46 Patellar Bone Tendon Bone – Whole………………………………………………………………..47 Extensor & Flexor Tendon …………………………………………………………………………...48 Rotator Cuff ……………………………………………………………………………………………49 Spine – Neuro……………………………………………………………………………………………..50-56 Iliac Crest Strip ………………………………………………………………………………………..50 Fibula …………………………………………………………………………………………………...51 Iliac Crest Block ……………………………………………………………………………………….52 Iliac Crest Wedge ……………………………………………………………………………………..53 Bone Plug w/ Cortical End …………………………………………………………………………...54 Patella Wedge …………………………………………………………………………………………55 Dura Mater……………………………………………………………………………………………...56 OsteoArticular – Oncology Division Total Joints…………………………………………………..57-60 Elbow …………………………………………………………………………………………………...57 Distal Femur .…………………………………………………………………………………………..58 Hemipelvis ……………………………………………………………………………………………..59 Scapula ………………………………………………………………………………………………...60 Oral & Maxillofacial………………………………………………………………………………………61-63 Rib ………………………………………………………………………………………………………61 Mandible ……………………………………………………………………………………………….62 Mandibular & Maxilla (M&M) Blocks ………………………………………………………………..63 Fresh………………………………………………………………………………………………………..64-66 Femur Condyle ………………………………………………………………………………………..64 Meniscus w/ Plateau ………………………………………………………………………………….65 Ankle en Bloc & Talus…………………………………………………………………………………66 UMTB Safety Letter from Dr. H. Thomas Temple...…………………………………………………….67 Page 3 of 68 Allograft Information General Information: What is an allograft? An allograft is soft tissue or bone that is removed from a human donor and used to surgically repair damaged bones, joints and tendons. Over 1,000,000 allografts are implanted each year. In orthopedics, an allograft is commonly used during ACL/PCL reconstructions, primary revision knee/hip reconstruction and massive defects following tumor surgery. Why is an allograft used? Because of inadequate amounts of autograft (a person’s own bone or soft tissue) and the limited size and shape of a person’s own bone, allograft is commonly used in reconstructive surgery of the hip, knee and long bones, as well as in cases of bone loss due to trauma or tumors. Using allograft tissue from another person will eliminate the need for a second operative site to remove autograft bone or tendon, reduce the risk of infection at a separate surgical site, and safeguard against pain and loss of function at or near the secondary site. Where does an allograft come from? A person has a choice regarding whether or not to donate their organs and tissues. These donors are otherwise healthy people who have experienced a sudden illness or accident which ultimately led to death. What types of screening/safety measures are taken? Before donation, all potential donors must undergo strict screening scrutiny that includes physical examination, comprehensive medical history and social risk review. A detailed medical history that includes social background and medical issues is obtained. The information collected on potential donors is compared against criteria established by the United States Public Health Service to identify and exclude individuals with high-risk behaviors. Furthermore, all tissue is held in quarantine until microbiological and blood tests are completed. These tests are required by the American Association of Tissue Banks (AATB) and the U.S. Food & Drug Administration (FDA) and include an analysis of infectious diseases such as HIV, hepatitis B and C and syphilis. All of the information is evaluated by a team of medical specialists in the fields of microbiology, orthopaedic surgery, pathology and tissue banking. No allograft can be released until the tissue bank’s medical director determines the tissue to be safe after review of the clinical and laboratory data. How safe is an allograft? Preparing the tissue for transplant begins with the removal of debris and organic matter. The allograft is then soaked in various solutions to prevent the transmission of bacteria and viruses. Processing and packaging are performed using aseptic techniques in clean room conditions to maintain biological integrity. On occasion, low dose radiation is used to aid in sterilization. Final processed tissues are tested for microbiological contamination in accordance with United States Pharmacopeia (USP) guidelines to ensure compliance with regulatory requirements. Although there is a theoretical risk for disease transmission, allograft transmitted infections are rare. The FDA has regulated this field very closely since 1993 to ensure allograft transplant safety. Over the past decade, more than five million musculoskeletal allografts have been distributed to surgeons for transplant into patients with a remarkable record of safety. Page 4 of 68 Statement from UMTB’s Medical Director The University of Miami Tissue Bank is the first full-service civilian musculoskeletal tissue bank in the United States. This not-for-profit organization is accredited by the American Association of Tissue Banks and is registered with the Food and Drug Administration (FDA) it is licensed by State of Florida Agency for Health Administration, the State of New York Department of Health, the State of California Department of Health, the State of Maryland Department of Health, and the State of Delaware Department of Health. The tissue bank performs the tissue procurement and performs processing in accordance with existing professional standards and according to the FDA Good Manufacturing Practice Guidelines (GMP) and Good Tissue Practices (GTP). A detailed outline of the donor selection criteria and quality assurance procedures performed by the tissue bank in processing allografts is described on the following pages. H. Thomas Temple, MD Director, Tissue Bank Department of Orthopaedics University of Miami Miller School of Medicine University of Miami Tissue Bank (UMTB) Transplantation of tissues touches the lives of many people in two ways; on one hand, it affects the families of donors; on the other hand, it benefits the recipients. Transplanting bone into patients is probably the most common form of transplantation today. The other most frequent is the transplantation of corneas, skin and dura mater. Were it not for the understanding and generosity of the nearest relatives of donors from whom the allografts were obtained, this would not be possible. The advances in medical science and technology, plus the clinical experience gained during the last few decades, allow for the increasing utilization of tissue transplants in surgery. To make this possible and practical constitutes a major challenge, which requires the dedication of surgeons, pathologists, nurses, microbiologists, technicians and other support personnel. It also calls for a continuous effort on the part of researchers in both basic and applied sciences. The present brochure describes briefly and in general terms the way in which the Tissue Bank and the University of Miami Miller School of Medicine meet this challenge. The University of Miami Tissue Bank was founded in 1970 as the U.S. Navy Tissue Bank curtailed its service to civilian patients. These protocols and techniques were modified to keep pace with technology and to improve safety. The technical personnel employed by the University of Miami Tissue Bank during the first years of its operation were technicians trained by the U.S. Navy Tissue Bank. In its inception, bone and tissue allografts excised in Miami were freeze-dried by the U.S. Navy Tissue Bank on a sharing basis. Tissue allografts preserved by freezing in mechanical freezers or in the vapor phase of liquid nitrogen were processed locally. Since the activities of the Tissue Bank have increased, the staff has expanded. So too has the scope of processing. The past faculty members of the Department of Orthopaedics and Rehabilitation participate in the activities of the Tissue Bank. Originally the Tissue Bank was housed in a three room operating room suite and an office. Now the Tissue Bank has a separate, dedicated O.R. suite for procurement, extensive aseptic processing rooms and other facilities used for the storage and preparation of Page 5 of 68 human tissue allografts under optimal conditions. In the early years, the number of donors from whom allografts were obtained varied from 20 to 40 yearly. The Tissue Bank now has over 500 multipletissue donors annually. It provides a full spectrum of services for the reconstructive surgery of the musculoskeletal system and for skin banking. In 1988, the University of Miami Tissue Bank acquired new facilities for the excision of tissues. A specially designed operating room suite reserved exclusively for the excision of tissues for transplantation was constructed in the Dr. Joseph H. Davis Center for Forensic Pathology. This was made possible by a grant from the Rotary Foundation of Miami. Currently the University of Miami Tissue Bank provides a wide range of services with emphasis on allografts used for the reconstruction of the musculoskeletal system. The first massive osteoarticular allograft prepared by the University of Miami Tissue Bank was transplanted in 1978; the first massive intercalary allograft in 1974. To date, the Tissue Bank has supplied over 10,000 massive allografts (osteoarticular, intercalary and structural prosthetic composite) to surgeons nationally and internationally. Massive osteoarticular allografts are cryopreserved and stored in the vapor phase of liquid nitrogen. Intercalary allografts are either quick-frozen or stored in the vapor phase of liquid nitrogen or are freeze-dried. Frozen and freeze-dried allografts used for reconstructive procedures of the axial skeleton as well as filling of smaller defects of bone and for arthrodesis have been supplied to surgeons on a routine basis since 1972. Skin allografts have also been distributed since that time. With few exceptions, all allografts distributed by the University of Miami Tissue Bank are excised and processed aseptically. Allografts are prepared and processed in accordance with the U.S. Food and Drug Administration’s regulations, as specified under Good Manufacturing Practices. In addition, the Tissue Bank prepares other secondarily sterilized bone allografts when specifically requested by the surgeon. The possibility of transmission of disease with transplanted allografts has been a major concern to the University of Miami Tissue Bank. This was heightened by the onset of the AIDS epidemic. To forestall this possibility, the biology and epidemiology of HIV has been the subject of study by University of Miami researchers. Some of these findings resulted in recommendations for quality control measures adopted by SEOPF and by the American Academy of Orthopaedic Surgeons. In an effort to improve the quality of life and to make transplants readily available to patients, the University of Miami Tissue Bank has assisted in the organization of new tissue banks in the United States and abroad. It has also provided training for personnel from other tissue banks from the U.S. and foreign countries and for surgeons interested in bone transplantation and tissue banking. Staff members of the University of Miami Tissue Bank have been particularly active in the clinical application of bone allografts in the reconstruction of failed total hip arthroplasties, reconstruction of the extremities following resection of tumors and in spinal surgery. As a result, the University of Miami has one of the largest orthopaedic oncology services in the world. In addition, transplantation of dura mater allografts for the closure of pachymeningeal defects has been primarily developed at this institution. The personnel of the Tissue Bank can view the accomplishments of the Tissue Bank with pride. These have been achieved only through the participation and collaboration of personnel on all levels. We look forward to the continuation of our activities and service to patients. Page 6 of 68 Not for Profit Organization The University of Miami Tissue Bank has not, does not and will not engage in the sale of human tissue. The sale of human tissue for financial compensation is illegal under Public Law 98-507, s.301; 42 United States Code s.274e; and Chapter 873, F.S. 59A1.005(11), F.A.C. The fees imposed on the recipients of allografts are for the recovery of direct expenses associated with the excision, preparation, storage, distribution and quality assurance studies of allografts. Financial records are audited periodically in keeping with University of Miami and State of Florida policies. Medical personnel fully trained in tissue banking and tissue transplantation: • H. Thomas Temple, M.D. (Director Tissue Bank, Department of Orthopaedics, University of Miami Miller School of Medicine) • Theodore I. Malinin, M.D. (Research, Tissue Bank, Department of Orthopaedics, University of Miami Miller School of Medicine) • Bill B. Buck, M.D. (Associate Director, Tissue Bank, Department of Orthopaedics, University of Miami Miller School of Medicine) • Paul Morris, M.D. (Associate Director, Tissue Bank, Department of Orthopaedics, University of Miami Miller School of Medicine) • Octavio V. Martinez, Ph.D. (Director, Microbiology Laboratory, Tissue Bank, Department of Orthopaedics, University of Miami Miller School of Medicine) All of the tissue bank physicians constitute the Medical Review Board. Safety and quality is the University of Miami Tissue Bank’s first priority • Not-for-profit organization • The first civilian (spin off from the U.S. Navy tissue bank) tissue bank in the industry • Multifunctional tissue bank • Performs the tissue excision and processing • Operational procedures exceeds AATB and FDA standards • Surgeon-to-surgeon consultations available • Physician participation in donor screening, prior to recovery, processing, and distribution • Post mortem examinations (autopsy) on all donors • Allograft transplantation by University of Miami School of Medicine surgeons serves as internal quality control • Follows Good Tissue Practices and Good Manufacturing Practice Guidelines • State of the art testing • Physicians (directors of the tissue bank) evaluate all information including tests results before release of tissue for clinical use. Licenses and Accreditations • Accredited by the American Association of Tissue Banks • Registered with the Food and Drug Administration • Certified by the State of Florida Agency for Health Care Administration • Licensed by the State of New York Department of Health • Licensed by the State of California Department of Health • Permitted by the State of Maryland Agency for Health Care Administration • Licensed by the State of Delaware Department of Health & Safety Page 7 of 68 Tracking of the Donor The University of Miami Tissue Bank’s records management system: • Permits tracing of a tissue from the donor to the consignee and from the consignee to the donor • Permits donor identification of a tissue at any phase of the operation • Indicates the dates and staff involved in each significant step of the operation from the time of retrieval through final disposition of the tissue as well as the tissue identification number(s) • Allows for laboratory and QC specimens related to a donor or tissue to be traceable to the donor Laboratory Screening The following mandatory tests are performed using approved methods by a certified laboratory: Tissues shall not be released for transplantation if blood results are reactive. The blood and/or tissue(s) of the donors were tested for/by the following and all the tests were found to be negative. TEST SYMBOL -Human Immunodeficiency Virus (HIV) HIV-1/2 Antibodies HIV-1/2-Ab Nucleic Acid Test for HIV-1 RNA HIV-1 NAT -Hepatitis B Virus (HBV) HBV Surface Antigen HBsAg HBV Core Antibody (IgG & IgM) HBcAb Nucleic Acid Test for HBV DNA (if applicable) HBV NAT -Hepatitis C Virus (HCV) HCV Antibody HCVAb Nucleic Acid Test for HCV RNA HCV NAT -Human T Cell Lymphotrophic Virus I/II (if applicable) HTLV-I/II Antibody HTLV-I/II-Ab -Syphilis – Rapid Plasma Reagin Screen RPR* Or T. Pallidum IgG T. pallidum IgG Tissue Preservation, Storage, Transit and Reconstitution Fresh (Refrigerated Temperature) Allografts: Femoral condyles, talus, patella, humerus head Preservation: Simple hypothermia is the storage of tissues at or about 1 ˚C to 10˚C that are usually immersed in nutrient culture media (examples: RPMI 1640- Roswell Park Memorial Institute, LR-Lactated Ringers, etc.) with antibiotics. This method of preservation is used for short-term storage only and is intended to preserve viable cells. The limitations of this preservation technique are evident in the short shelf-life Page 8 of 68 of the tissue graft. Hypothermia reduces the oxygen consumption of the viable cells, thereby slowing cellular metabolism and allowing the recovery of the maximum number of viable cells. Storage: The individual allografts are submerged in nutrient culture media with antibiotics. Upon arrival, allograft should have the appearance of floating in solution. If the liquid appears frozen, the graft should be treated as useless to its application. The cells have died and are not viable. The sterile packaging may be in plastic jars or pouches. Whatever the packaging, it is always sterile and in twofold. The circulator handles the outer packaging while handing the inner container to the scrubbed personnel. Transit: Pre-frozen foam refrigerant (ice packs/blue ice/wet ice) is packed around the fresh tissue in wellinsulated styrofoam boxes. Upon arrival to the hospital, if surgery is not immediate, remove allograft contained in its packaging from styrofoam box and place in the refrigerator compartment (not freezer!) until surgery. Reconstitution: Suitable thawing procedures for the fresh allograft, submerge into refrigerated 1˚C to 10˚C sterile lactated ringer’s bath with or without antibiotics. From recovery, processing, storage and shipment, the allograft has been kept at hypothermia. It is logical to reconstitute the graft in solutions at that temperature. Fresh Frozen Allografts: Bone-Patellar Tendon-Bone, Achilles Tendon with Bone Strut (Calcaneous), Semitendinosus/Gracilis Tendons, Tibialis Tendon, Peroneous Longus Tendon Preservation: The freezing of tissues at temperatures below -70˚C is routinely used for the long-term storage of musculoskeletal tissues. Storage at these temperatures is thought to inhibit enzymatic degradation of tissues, most notably collagenase and protease activity. An uncontrolled freeze of tissues at these temperatures does not aid in the preservation of viable cells; therefore, this technique is reserved for tissues in which cellular viability is not crucial to the clinical performance of the allografts. Many mechanical refrigeration devices are capable of attaining these temperatures. In addition, liquid nitrogen storage containers are quite suitable for the storage of these tissues, attaining temperatures as low as -196˚C. Storage: The individual allografts are frozen with little or no solution. The sterile packaging may be in plastic jars or pouches. Whatever the packaging, it is always aseptic and in twofold. The circulator handles the outer packaging while handing the inner container to the scrubbed personnel. Transit: Dry ice packed around the frozen tissue in well-insulated styrofoam or similar boxes has proven effective for maintaining frozen bone during transport to the user institution. Dry Ice (solid carbon Page 9 of 68 dioxide, temperatures about -76˚C) is acceptable for storage. The only drawback is that it is a logistical problem of checking the quantity levels of dry ice and restocking on a daily basis, depending on the size of the container. For suppliers of dry ice in your area—most supermarkets carry dry ice for sale or their own storage use—check the yellow pages under dry ice or carbonics. Standard mechanical freezers were manufactured to mimic the temperatures of dry ice to reduce logistical problems. However, for reliable long-term storage, it is necessary to reduce the temperature further. Cryopreservation Allografts: Distal Femurs, Proximal Tibias, Meniscal grafts, Hemipelvis, Proximal Humerus Preservation: Cryopreservation is the freezing of tissues at a controlled rate, usually 1 to 2 ˚C per minute, in the presence of a cryoprotectant solution (glycerol). This method is intended to preserve viable cells when their viability is thought to play an important role in the success of the allograft. Accurate controlled-rate freezing is usually computer controlled, with liquid nitrogen vapor as the coolant. Subsequent storage of these cryopreserved tissues is usually at liquid nitrogen vapor phase temperatures. Storage: The individual allografts are frozen with little or no solution. The sterile packaging is in plastic pouches and is always sterile and in twofold. The circulator handles the outer packaging while handing the inner container to the scrubbed personnel. Transit: Dry ice packed around the cryopreserved frozen tissue in well-insulated styrofoam or similar boxes has proven effective for maintaining frozen bone during transport to the user institution. Dry Ice (solid carbon dioxide, temperatures about -76˚C) is acceptable for storage. The only drawback is that it is a logistical problem of checking the quantity levels of dry ice and restocking on a daily basis, depending on the size of the container. For suppliers of dry ice in your area—most supermarkets carry dry ice for sale or their own storage use—check the yellow pages under dry ice or carbonics. Standard mechanical freezers were manufactured to mimic the temperatures of dry ice to reduce logistical problems. However, for reliable long-term storage, it is necessary to reduce the temperature still further. Liquid nitrogen: Only at about -120˚C does gradual growth of ice crystals completely cease. Liquid nitrogen provides a range of cryogenic temperatures. A property of major importance in liquid nitrogen is its chemical inertness. Unlike carbon dioxide or other solvents used, it does not react with the materials with which it comes in contact. It has no effect on the pH of frozen tissue and vaporizes without leaving a residue. Temperatures range from -130˚C to -196˚C. Tissues should be placed in the vapor phase above liquid nitrogen because the packaging of allograft may not withstand the incredibly ultra cold characteristic of the liquid. Reconstitution: Suitable thawing procedures Submerge the cryopreserved frozen allograft into a 22-37˚C sterile lactated ringer or similar solution Page 10 of 68 with or without antibiotics. Note: Overly heated solutions will denature the tissues and render them useless. Short Term Storage—Frozen Graft Storage of bone in conventional freezers (about -20˚C) is popular because it requires only easily obtainable, generally available freezers. However, at this temperature ice crystals grow and eventually destroy the bone. In addition to a mechanical disruption by ice crystals, injury from freezing is caused by factors which may include dehydration, metabolic aberrations resulting from storage at temperatures at which some enzymes may continue to function and direct chemical injury. Freeze Dried / Lyophilized Preservation: Freeze-drying is the removal of water from a substance under vacuum, transforming the water in its crystalline form to water vapor without its ever passing through the liquid phase. This phenomenon is termed sublimation. This means of preserving tissue was first implemented by the U.S. Navy Tissue Bank. Lyophilization is quite useful in the long-term preservation and storage tissues when other means are impractical. Once tissue is freeze-dried, it can be maintained at room temperatures without the need for special handling and can be distributed over long distances. Freeze drying is purported to alter the biomechanical properties of tissues; therefore, rehydration of the tissue prior to use is required to restore these properties. Storage: The individual allografts packaging may be in glass jars or plastic pouches. Whatever the packaging, it is always aseptic. The circulator handles the outer packaging while handing the inner container to the scrubbed personnel. Transit: Freeze dried tissue is placed to avoid breakage and is shipped at ambient temperatures. Reconstitution: Suitable thawing procedures Submerge the freeze-dried allograft into a 22 ˚C–37˚C sterile saline baths (0.9% sodium chloride) with or without antibiotics. This should be done as the surgery is beginning. By the time the surgical site is prepared to receive the allograft, the tissue will be thawed. Note: Overly heated solutions will denature the tissues and render them useless. Page 11 of 68 General Orthopedics – Trauma and Reconstruction RADIUS Product Code Product Description Preservation Sterilization Category 0363 1181 0729 1817 Radius Segment Radius Segment Radius Shaft Radius Shaft Freeze Dried Fresh Frozen Freeze Dried Fresh Frozen Aseptic Aseptic Aseptic Aseptic Base Bone Base Bone Base Bone Base Bone Common Graft Utilization: Tumor Resection, Fracture Management, Spine Features / Benefits: Segment: < 15cm Shaft: > 15cm The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 12 of 68 General Orthopedics – Trauma and Reconstruction ULNA Product Code Product Description Preservation Sterilization Category 0165 Ulna Segment Freeze Dried Aseptic Base Bone 1239 Ulna Shaft Freeze Dried Aseptic Base Bone Common Graft Utilization: Tumor Resection, Fracture Management, Total Joint Augmentation Features / Benefits: Segment: L < 15cm Shaft: L > 15cm The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 13 of 68 General Orthopedics – Trauma and Reconstruction TIBIA PLATE/STRUT Product Code Product Description Preservation Sterilization Category 0723 Tibia Plate Small <15cm Tibia Plate Medium ≥15cm <20cm Freeze Dried Aseptic Base Bone Freeze Dried Aseptic Base Bone Tibia Plate Large ≥20cm Freeze Dried Aseptic Base Bone Fresh Frozen Aseptic Base Bone Fresh Frozen Aseptic Base Bone Freeze Dried Aseptic Base Bone 0139 0509 0321 0520 1898 Tibia Plate Medium ≥15cm <20cm Tibia Plate Large ≥20cm Tibia Plate Flat W = 2.2 - 2.7cm, L = 14.9 - 18cm Common Graft Utilization: Tumor Resection, Fracture Management Features / Benefits: Tibia Plate Flat width and thickness is consistent throughout graft. The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 14 of 68 General Orthopedics – Trauma and Reconstruction PROXIMAL TIBIA Product Code Product Description Preservation Sterilization Category 0084 Distal Tibia – Left Cryopreserved Aseptic OsteoArticular 0083 Distal Tibia – Right Proximal Tibia w/ Patella - Right Proximal Tibia w/ Patella – Left Cryopreserved Aseptic OsteoArticular Cryopreserved Aseptic OsteoArticular Cryopreserved Aseptic OsteoAritcular 0188 0189 Common Graft Utilization: Tumor Resection, Fracture Management, Joint Replacement Key Features & Benefits: Sizes may be patient matched The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 15 of 68 General Orthopedics – Trauma and Reconstruction TIBIA SEGMENT/TIBIA SHAFT Product Code 0073 0074 0448 0011 Product Description Tibia Segment <15cm Tibia Shaft ≥15cm Tibia Segment <15cm Tibia Shaft ≥15cm Preservation Freeze Dried Freeze Dried Fresh Frozen Fresh Frozen Sterilization Aseptic Aseptic Aseptic Aseptic Category Base Bone Base Bone Base Bone Base Bone Common Graft Utilization: Tumor Resection, Fracture Management, Total Joint Augmentation Features / Benefits: Multiple lengths available The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 16 of 68 General Orthopedics – Trauma and Reconstruction FEMUR CONDYLE W/O CARTILAGE Product Code Product Description Preservation Sterilization Category 0067 Femur Condyle Hemi Femur Condyle Lateral Femur Condyle Medial Freeze Dried Aseptic Base Bone Fresh Frozen Aseptic Base Bone Fresh Frozen Aseptic Base Bone 0417 0418 Common Graft Utilization: Tumor Resection, Trauma Cases, Joint Arthroplasty, Fracture Management, Filling Osseous Defects/Voids Features / Benefits: The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 17 of 68 General Orthopedics – Trauma and Reconstruction DISTAL FEMUR W/ CONDYLES Product Code Product Description Preservation Sterilization Category 0144 Distal Femur - Left Fresh Frozen Aseptic Base Bone 0124 Distal Femur - Right Distal Femur w/ ligaments Left Distal Femur w/ ligaments Right Fresh Frozen Aseptic Base Bone Cryopreserved Aseptic OsteoArticular Cryopreserved Aseptic OsteoArticular 0082 0081 Common Graft Utilization: Tumor Resection, Fracture Management, Joint Revision & Replacement Features / Benefits: Shaft L = 15cm The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 18 of 68 General Orthopedics – Trauma and Reconstruction FEMUR HEAD Product Code Product Description Preservation Sterilization Category 0039 0495 0038 1290 Femur Head Femur Head Femur Head Femur Head Freeze Dried Freeze Dried Fresh Frozen Fresh Frozen Aseptic Irradiated Aseptic Irradiated Base Bone Base Bone Base Bone Base Bone Common Graft Utilization: Total Hip Revisions and Osteoplasties, Tumor Resection, Joint Arthroplasty, Fracture Management, Filling Osseous Defects/Voids, Features / Benefits: Various sizes available The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 19 of 68 General Orthopedics – Trauma and Reconstruction FEMUR PLATE (STRUT) Product Code 0138 0191 0519 0522 Product Description Femur Plate Medium ≥ 15cm <20cm Femur Plate Medium ≥ 15cm <20cm Femur Plate Large ≥ 20cm Femur Plate Large ≥ 20cm Preservation Sterilization Category Freeze Dried Aseptic Base Bone Fresh Frozen Aseptic Base Bone Freeze Dried Aseptic Base Bone Fresh Frozen Aseptic Base Bone Common Graft Utilization: Tumor Resection, Fracture Management Features / Benefits: The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 20 of 68 General Orthopedics – Trauma and Reconstruction PROXIMAL FEMUR Product Code 0449 0726 0730 0248 Product Description Proximal Femur w/Head Left Proximal Femur w/ Head – Right Proximal Femur w/ Ligaments - Left Proximal Femur w/ Ligaments - Right Preservation Sterilization Category Cryopreserved Aseptic OsteoArticular Cryopreserved Aseptic OsteoArticular Fresh Frozen Aseptic Base Bone Fresh Frozen Aseptic Base Bone Common Graft Utilization: Tumor Resection, Fracture Management, Joint Revision Features / Benefits: Various sizes available May be patient matched The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 21 of 68 General Orthopedics – Trauma and Reconstruction FEMUR SHAFTS & SEGMENTS Product Code Product Description Preservation Sterilization Category 0035 0037 0034 0036 Femur Segment <15cm Femur Shaft ≥15cm Femur Segment <15cm Femur Shaft ≥15cm Freeze Dried Freeze Dried Fresh Frozen Fresh Frozen Aseptic Aseptic Aseptic Aseptic Base Bone Base Bone Base Bone Base Bone Common Graft Utilization: Tumor Resection, Fracture Management Features / Benefits: The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 22 of 68 General Orthopedics – Trauma and Reconstruction FIBULA SHAFTS & SEGMENTS Product Code 3029 3029r 0047 0486 3030 3030r 0049 0048 Product Description Fibula Segment 2.0 – 4.9cm Fibula Segment 2.0 – 4.9cm Fibula Segment 5.0 – 9.9cm Fibula Segment 5.0 – 9.9cm Fibula Segment 10.0 – 14.9cm Fibula Segment 10.0 – 14.9cm Fibula Shaft ≥15cm Fibula Shaft ≥15cm Preservation Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Fresh Frozen Sterilization Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Aseptic Aseptic Category Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Common Graft Utilization: Tumor Resection, Fracture Management, Spine Surgery Features / Benefits: The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 23 of 68 General Orthopedics – Trauma and Reconstruction HUMERUS SHAFTS & SEGMENTS Product Code Product Description Preservation Sterilization Category 0050 0052 Humerus Segment Humerus Shaft Freeze Dried Freeze Dried Aseptic Aseptic Base Bone Base Bone 0053 Humerus Shaft Fresh Frozen Aseptic Base Bone Common Graft Utilization: Tumor Resection, Fracture Management Features / Benefits: Segment: L <15cm Shaft: L > 15cm The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 24 of 68 General Orthopedics – Trauma and Reconstruction PROXIMAL HUMERUS W/ SOFT TISSUE Product Code 1799 1497 1800 1498 0095 0094 0098 0099 Product Description Proximal Humerus w/ Ligaments – Left Proximal Humerus – Left Proximal Humerus w/ Ligaments - Right Proximal Humerus - Right Proximal Humerus w/ Head & Ligaments – Left Proximal Humerus w/ Head & Ligaments - Right Whole Humerus – Left Whole Humerus – Right Preservation Sterilization Category Fresh Frozen Aseptic Base Bone Fresh Frozen Irradiated Base Bone Fresh Frozen Aseptic Base Bone Fresh Frozen Irradiated Base Bone Cryopreserved Aseptic OsteoArticular Cryopreserved Aseptic OsteoArticular Cryopreserved Cyropreserved Aseptic Aseptic OsteoArticular OsteoArticular Common Graft Utilization: Tumor Resection, Fracture Management, Total Joint Replacement Features / Benefits: May be patient matched Total L= ≥15cm The rotator cuff and surrounding tissue attachments are L = min 2cm The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 25 of 68 General Orthopedics – Trauma and Reconstruction CANCELLOUS CRUSHED 2-10MM Product Code 1612 1615 0033 1500 1404 1592 0545 1383 1405 1481 0027 1499 Product Description Cancellous Crushed 05cc Cancellous Crushed 05cc Cancellous Crushed 10cc Cancellous Crushed 10cc Cancellous Crushed 15cc Cancellous Crushed 15cc Cancellous Crushed 20cc Cancellous Crushed 20cc Cancellous Crushed 30cc Cancellous Crushed 30cc Cancellous Crushed 40cc Cancellous Crushed 40cc Preservation Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Sterilization Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Category Particulate Particulate Particulate Particulate Particulate Particulate Particulate Particulate Particulate Particulate Particulate Particulate Common Graft Utilization: Spinal Fusion, Space Filling, Sinus Augmentation Features / Benefits: Fresh Frozen may be stocked upon request Larger volume may be stocked upon request The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 26 of 68 General Orthopedics – Trauma and Reconstruction CANCELLOUS CUBES 4-10MM Product Code 1521 1625 0580 1136 0560 1545 0567 0488 0559 1549 0566 0485 Product Description Cancellous Cubes 05cc Cancellous Cubes 05cc Cancellous Cubes 10cc Cancellous Cubes 10cc Cancellous Cubes 15cc Cancellous Cubes 15cc Cancellous Cubes 20cc Cancellous Cubes 20cc Cancellous Cubes 30cc Cancellous Cubes 30cc Cancellous Cubes 40cc Cancellous Cubes 40cc Preservation Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Sterilization Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Category Particulate Particulate Particulate Particulate Particulate Particulate Particulate Particulate Particulate Particulate Particulate Particulate Common Graft Utilization: Spinal Fusion, Space Filling, Sinus Augmentation Features / Benefits: Fresh Frozen may be stocked upon request Larger volume may be stocked upon request The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 27 of 68 General Orthopedics – Trauma and Reconstruction CANCELLOUS POWDER 100-200M Product Code 3013 3013r 1454 1628 1455 1667 1456 1704 Product Description Cancellous Powder 05cc Cancellous Powder 05cc Cancellous Powder 10cc Cancellous Powder 10cc Cancellous Powder 20cc Cancellous Powder 20cc Cancellous Powder 40cc Cancellous Powder 40cc Preservation Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Sterilization Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Category Particulate Particulate Particulate Particulate Particulate Particulate Particulate Particulate Common Graft Utilization: Spinal Fusion, Space Filling, Sinus Augmentation Features / Benefits: Fresh Frozen may be stocked upon request Larger volume may be stocked upon request The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 28 of 68 General Orthopedics – Trauma and Reconstruction CANCELLOUS MORSELIZED 1-4MM Product Code 3039 3039r 0847 1133 1842 1783 0691 1134 1843 1844 0690 1135 Product Description Cancellous Morselized 05cc Cancellous Morselized 05cc Cancellous Morselized 10cc Cancellous Morselized 10cc Cancellous Morselized 15cc Cancellous Morselized 15cc Cancellous Morselized 20cc Cancellous Morselized 20cc Cancellous Morselized 30cc Cancellous Morselized 30cc Cancellous Morselized 40cc Cancellous Morselized 40cc Preservation Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Sterilization Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Category Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Common Graft Utilization: Space filling Features / Benefits: Larger sizes may be stocked upon request. The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 29 of 68 General Orthopedics – Trauma and Reconstruction CORTICAL MORSELIZED 1-4MM Product Code 0505 1744 0692 1145 0409 1146 Product Description Cortical Morselized 10cc Coritcal Morselized 10cc Cortical Morselized 20cc Cortical Morselized 20cc Cortical Morselized 40cc Cortical Morselized 40cc Preservation Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Sterilization Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Category Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Common Graft Utilization: Space filing Features / Benefits: The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 30 of 68 General Orthopedics – Trauma and Reconstruction CORTICAL CANCELLOUS MORSELIZED 1-4MM Product Code 1258 1376 1257 1377 1256 1378 Product Description Cortical Cancellous Morselized 30cc Cortical Cancellous Morselized 30cc Cortical Cancellous Morselized 60cc Cortical Cancellous Morselized 60cc Cortical Cancellous Morselized 90cc Cortical Cancellous Morselized 90cc Preservation Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Sterilization Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Category Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Common Graft Utilization: Space filing Features / Benefits: The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 31 of 68 General Orthopedics – Trauma and Reconstruction CORTICAL POWDER 100-200m Product Code Product Description Preservation Sterilization Category 1631 1458 1138 1459 1139 1460 1140 Cancellous Powder 05cc Cancellous Powder 05cc Cancellous Powder 10cc Cancellous Powder 10cc Cancellous Powder 20cc Cancellous Powder 20cc Cancellous Powder 40cc Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Aseptic Particulate Particulate Particulate Particulate Particulate Particulate Particulate Common Graft Utilization: Spinal Fusion, Space Filling, Sinus Augmentation Features / Benefits: Fresh Frozen may be stocked upon request Larger volume may be stocked upon request The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 32 of 68 General Orthopedics – Trauma and Reconstruction FEMUR HEAD Product Code Product Description Preservation Sterilization Category 1493 0707 Femur Head - Left Femur Head - Right Cryopreserved Cryopreserved Aseptic Aseptic OsteoArticular OsteoArticular Common Graft Utilization: Cartilage Replacement, Articular Resurfacing Key Features & Benefits: May be patient matched The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 33 of 68 General Orthopedics – Trauma and Reconstruction OSTEOTOMY WEDGE Product Code Product Description Preservation Sterilization Category 0809 1178 0779 1177 Osteotomy Wedge (2 Piece) Osteotomy Wedge (2 Piece) Osteotomy Wedge Osteotomy Wedge Freeze Dried Freeze Dried Freeze Dried Freeze Dried Aseptic Irradiated Aseptic Irradiated Base Bone Base Bone Base Bone Base Bone Common Graft Utilization: High Tibial Osteotomy Features / Benefits: 2 per package: W = min 2cm X L = 5cm X H = min 1.75cm 1 per package: W = min 3cm X L = 6cm X H = min 1.75cm The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 34 of 68 General Orthopedics – Trauma and Reconstruction METACARPAL Product Code 0360 0410 0228 0225 0229 0226 0230 0227 0231 0232 Product Description Metacarpal/Phalanx #1- Left Metacarpal/Phalanx #1 –Right Metacarpal/Phalanx #2 - Left Metacarpal/Phalanx #2 - Right Metacarpal/Phalanx #3 –Left Metacarpal/Phalanx #3 – Right Metacarpal/Phalanx #4 – Left Metacarpal/Phalanx #4 – Right Metacarpal/Phalanx #5 – Left Metacarpal/Phalanx #5 – Right Preservation Cryopreserved Cryopreserved Cryopreserved Cryopreserved Cryopreserved Cryopreserved Cryopreserved Cryopreserved Cryopreserved Cryopreserved Sterilization Aseptic Aseptic Aseptic Aseptic Aseptic Aseptic Aseptic Aseptic Aseptic Aseptic Category OsteoArticular OsteoArticular OsteoArticular OsteoArticular OsteoArticular OsteoArticular OsteoArticular OsteoArticular OsteoArticular OsteoArticular Common Graft Utilization: Joint replacement, Trauma Features /Benefits: May be patient matched The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 35 of 68 General Orthopedics – Trauma and Reconstruction METARSAL Product Code Product Description Preservation Sterilization Category 0462 0461 0539 0538 0540 0240 0541 0241 0696 0242 Metatarsal #1 – Left Metatarsal #1 – Right Metatarsal #2 - Left Metatarsal #2 – Right Metatarsal #3 – Left Metatarsal #3 – Right Metatarsal #4 – Left Metatarsal #4 – Right Metatarsal #5 – Left Metatarsal #5 – Right Cryopreserved Cryopreserved Cryopreserved Cryopreserved Cryopreserved Cryopreserved Cryopreserved Cryopreserved Cryopreserved Cryopreserved Aseptic Aseptic Aseptic Aseptic Aseptic Aseptic Aseptic Aseptic Aseptic Aseptic OsteoArticular OsteoAritcular OsteoArticular OsteoArticular OsteoArticular OsteoArticular OsteoArticular OsteoArticular OsteoArticular OsteoArticular Common Graft Utilization: Tumor resection, Joint replacement, Trauma Features / Benefits: May be patient matched The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 36 of 68 General Orthopedics – Trauma and Reconstruction RIB CARTILAGE Product Code Product Description Preservation Sterilization Category 0155 1518 0160 1420 Rib Cartilage Rib Cartilage Rib Cartilage Rib Cartilage Freeze Dried Freeze Dried Fresh Frozen Fresh Frozen Aseptic Irradiated Aseptic Irradiated Base Bone Base Bone Base Bone Base Bone Common Graft Utilization: Plastic Surgery, Reconstructive Surgery Features / Benefits: L > min 3cm W = min 1cm Various lengths and widths The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 37 of 68 General Orthopedics – Trauma and Reconstruction FASCIA Product Code 0006 0428 0716 0759 1194 0763 0154 1317 1316 1827 Product Description Fascia Lata Fascia Lata Fascia Lata – Patch Fascia Lata – Sling Fascia Lata – Sling Fascia Lata – Strip Fascia Lata Fascia Lata Fascia Lata - Sling UM Fanfold Fascia Preservation Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Fresh Frozen Fresh Frozen Fresh Frozen Fresh Frozen Sterilization Aseptic Irradiated Aseptic Aseptic Irradiated Aseptic Aseptic Irradiated Irradiated Aseptic Category Soft Tissue Soft Tissue Soft Tissue Soft Tissue Soft Tissue Soft Tissue Soft Tissue Soft Tissue Soft Tissue Soft Tissue Common Graft Utilization: Pubovaginal Sling/Urinary Stress Incontinence, Periodontal and Ridge Defects, Membrane Barrier when primary closure cannot be obtained Key Features & Benefits: Patch: 20cm2 or 4cm x 5cm; Sling: W≥4.0cm, L = min 15cm; Strip: W = 0.5cm - 1.0 cm, L= min 20cm; Large Freeze Dried: W = min 8.0cm, L = min 18cm; Large Frozen: W = min. 10 cm, L = min 20cm Large graft: W=10cm L=20cm The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 38 of 68 Sports Medicine MENISCUS W/ BLOCK Product Code 0775 0781 0818 0808 1555 1559 1554 1558 1553 1557 1552 1556 Product Description Meniscus Medial w/ Block – Left Meniscus Medial w/ Block – Right Meniscus Lateral w/ Block – Left Meniscus Lateral w/ Block – Right Meniscus Medial w/ Block – Left Meniscus Medial w/ Block – Left Meniscus Lateral w/ Block - Left Meniscus Lateral w/ Block – Left Meniscus Medial w/ Block – Right Meniscus Medial w/ Block –Right Meniscus Lateral w/ Block – Right Meniscus Lateral w/ Block – Right Preservation Sterilization Cryopreserved Aseptic Cryopreserved Aseptic Cryopreserved Aseptic Cryopreserved Aseptic Fresh Frozen Aseptic Fresh Frozen Irradiated Fresh Frozen Aseptic Fresh Frozen Irradiated Fresh Frozen Aseptic Fresh Frozen Irradiated Fresh Frozen Aseptic Fresh Frozen Irradiated Category Sports Medicine Sports Medicine Sports Medicine Sports Medicine Sports Medicine Sports Medicine Sports Medicine Sports Medicine Sports Medicine Sports Medicine Sports Medicine Sports Medicine Common Graft Utilization: Meniscus Replacement, Glenoid Resurfacing Features / Benefits: LB = Length of Bone Block, measured at widest point TB = Thickness of Bone Block; min 1.5cm WB = Width of Bone Block, measured at widest point The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 39 of 68 Sports Medicine MENISCUS W/ PLATEAU Product Code 0193 0126 0427 1632 1581 1644 Product Description Meniscus w/ Plateau – Left Meniscus w/ Plateau – Right Meniscus w/ Plateau – Left Meniscus w/ Plateau – Left Meniscus w/ Plateau – Right Meniscus w/ Plateau – Right Preservation Cryopreserved Cryopreserved Fresh Frozen Fresh Frozen Fresh Frozen Fresh Frozen Sterilization Aseptic Aseptic Aseptic Irradiated Aseptic Irradiated Category Sports Medicine Sports Medicine Sports Medicine Sports Medicine Sports Medicine Sports Medicine Common Graft Utilization: Meniscus Replacement, Glenoid Resurfacing Features / Benefits: Whole available May be patient matched The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 40 of 68 Sports Medicine FEMUR CONDYLE Product Code 0440 0439 0728 0704 0727 0423 Product Description Whole Femur Condyle – Left Whole Femur Condyle – Right Lateral Femur Condyle – Left Lateral Femur Condyle – Right Medial Femur Condyle – Left Medial Femur Condyle - Right Preservation Cryopreserved Cryopreserved Cryopreserved Cryopreserved Cryopreserved Cryopreserved Sterilization Aseptic Aseptic Aseptic Aseptic Aseptic Aseptic Category OsteoArticulatar OsteoArticulatar OsteoArticulatar OsteoArticulatar OsteoArticulatar OsteoArticulatar Common Graft Utilization: Cartilage Replacement, Articular Resurfacing Features / Benefits: May be patient matched The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 41 of 68 Sports Medicine ACHILLES Product Code Product Description Preservation Sterilization Category 0009 0765 1288 1532 Achilles Tendon w/ Bone Block Achilles Tendon w/ Bone Block Achilles Tendon w/o Bone Block Achilles Tendon w/o Bone Block Fresh Frozen Fresh Frozen Fresh Frozen Fresh Frozen Aseptic Irradiated Aseptic Irradiated Sports Medicine Sports Medicine Sports Medicine Sports Medicine Common Graft Utilization: Anterior/posterior cruciate ligament replacement, Reconstruction, Extensor Mechanism Replacement Key Features & Benefits: Available in variable dimensions. Call UMTB for sizes Bone Block L = min 25mm Tendon L ≥ 200 mm LB = Length of Bone Block WB = Width of Bone Block LT =Length of Tendon WT = Width of Tendon The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 42 of 68 Sports Medicine ANTERIOR TIBIALIS TENDON Product Code Product Description Preservation Sterilization Category 0332 1198 Anterior Tibialis Tendon Anterior Tibialis Tendon Fresh Frozen Fresh Frozen Aseptic Irradiated Sports Medicine Sports Medicine Common Graft Utilization: Anterior/Posterior Cruciate Ligament Replacement and Reconstruction, Tendon Repair Features / Benefits: Call UMTB for sizes D = Double Loop; W ≥ 7mm DL measured in linear < 7mm L = min 240mm The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 43 of 68 Sports Medicine POSTERIOR TIBIALIS TENDON Product Code 0333 1199 Product Description Posterior Tibialis Tendon Posterior Tibialis Tendon Preservation Fresh Frozen Fresh Frozen Sterilization Aseptic Irradiated Category Sports Medicine Sports Medicine Common Graft Utilization: Anterior/Posterior Cruciate Ligament Replacement and Reconstruction, Tendon Repair, Rotator Cuff Repair Key Features & Benefits: Call UMTB for sizes L = min 240mm D = Double Loop; W ≥ 7mm DL measured in linear; W < 7mm The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 44 of 68 Sports Medicine PERONEUS LONGUS TENDON Product Code Product Description Preservation Sterilization Category 0336 1201 Peroneus Longus Tendon Peroneus Longus Tendon Fresh Frozen Fresh Frozen Aseptic Irradiated Sports Medicine Sports Medicine Common Graft Utilization: Anterior/Posterior Cruciate Ligament Replacement and Reconstruction, Tendon Repair Features / Benefits: Call UMTB for sizes D = Double Loop; W ≥ 7mm DL measured in linear; W < 7mm L = min 240mm The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 45 of 68 Sports Medicine SEMITENDINOSUS & GRACILIS Product Code Product Description Preservation Sterilization Category 1746 1748 Gracilis Tendon Gracilis Tendon Fresh Frozen Fresh Frozen Aseptic Irradiated Sports Medicine Sports Medicine 1745 1747 0783 1200 SemiT Tendon SemiT Tendon SemiT Gracilis Tendon SemiT Gracilis Tendon Fresh Frozen Fresh Frozen Fresh Frozen Fresh Frozen Aseptic Irradiated Aseptic Irradiated Sports Medicine Sports Medicine Sports Medicine Sports Medicine Common Graft Utilization: Anterior/Posterior Cruciate Ligament Replacement and Reconstruction, Tendon Repair Features / Benefits: Call UMTB for sizes L = min 240mm D = Double Loop; W ≥ 7mm LG = Length of Gracilis LST =Length of SemiTendinosus DL measured in linear; W < 7mm The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 46 of 68 Sports Medicine PATELLAR BONE TENDON BONE – HALF Product Code 0008 0414 Product Description Patella Tendon w/ Bone Block - Half Patella Tendon w/ Bone Block - Half Preservation Sterilization Category Fresh Frozen Aseptic Sports Medicine Fresh Frozen Irradiated Sports Medicine Common Graft Utilization: Anterior/posterior cruciate ligament replacement and reconstruction and extensor mechanism replacement Features / Benefits: Bone Block tibia tubercle; L = min 20mm, W = min 12mm LP = Length of patella LPL = Length of patella ligament LTS = Length of tibia bone LQT = Length of quad tendon WT = Width of tendon WB = Width of bone TB = Thickness of bone The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 47 of 68 Sports Medicine PATELLAR BONE TENDON BONE - WHOLE Product Code 0264 0766 0263 0550 Product Description Patella Tendon w/ Bone Block – Left Patella Tendon w/ Bone Block – Left Patella Tendon w/ Bone Block – Right Patella Tendon w/ Bone Block – Right Preservation Sterilization Category Fresh Frozen Aseptic Sports Medicine Fresh Frozen Irradiated Sports Medicine Fresh Frozen Aseptic Sports Medicine Fresh Frozen Irradiated Sports Medicine Common Graft Utilization: Anterior/Post Cruciate Ligament Replacement/Reconstruction, Extensor Mechanism Replacement Features / Benefits: Bone Block: L = min 25mm, W ≥ 10 mm LP = Length of patella LPL = Length of patella ligament LPB = Length of tibia bone LQT = Length of quad tendon WT = Width of tendon WB = Width of bone TB = Thickness of bone WC = Width of Patella The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 48 of 68 Sports Medicine EXTENSOR & FLEXOR TENDON Product Code 0799 Product Description Extensor Tendon (Arm) Preservation Cryopreserved Sterilization Aseptic Category Sports Medicine 0800 Flexor Tendon (Arm) Cryopreserved Aseptic Sports Medicine Common Graft Utilization: Anterior/Posterior Cruciate Ligament Replacement and Reconstruction, Tendon Repair Features / Benefits: Call UMTB for sizes The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 49 of 68 Sports Medicine ROTATOR CUFF Product Code Product Description Preservation Sterilization Category 0014 Rotator Cuff Fresh Frozen Aseptic Sports Medicine Common Graft Utilization: Rotator Cuff Repair Features / Benefits: Call UMTB for sizes Rotator W = min 2cm The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 50 of 68 Spine - Neuro ILIAC CREST STRIP Product Code Product Description Preservation Sterilization Category 0055 1189 0473 1190 0056 1191 Iliac Crest Strip Small Iliac Crest Strip Small Iliac Crest Strip Medium Iliac Crest Strip Medium Iliac Crest Strip Large Iliac Crest Strip Large Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Common Graft Utilization: Spinal Surgery Features / Benefits: Small: W < 70mm Medium: W= 70-90mm Large: W > 90mm The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 51 of 68 Spine – Neuro FIBULA Product Code 3029 3029r 0047 0486 3030 3030r 0049 Product Description Fibular Segment 2cm – 4.9cm Fibular Segment 2cm – 4.9cm Fibula Segment 5cm – 9.9cm Fibula Segment 5cm – 9.9cm Fibula Segment 10cm – 14.9cm Fibula Segment 10cm – 14.9cm Fibula Shaft ≥ 15cm Preservation Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Sterilization Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Aseptic Category Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Common Graft Utilization: Anterior Cervical Fusion Features / Benefits: The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 52 of 68 Spine – Neuro ILIAC CREST BLOCK Product Code 0064 0499 Product Description Iliac Crest Block Iliac Crest Block Preservation Sterilization Category Freeze Dried Freeze Dried Aseptic Irradiated Base Bone Base Bone Common Graft Utilization: Spinal Fusion, Tibial Wedge Osteotomy, Ankle Fusion Features / Benefits: L = 7 cm W = min 2cm The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 53 of 68 Spine - Neuro ILIAC CREST WEDGE Product Code 1329 1329r 1330 1330r 1331 1331r 1332 1332r 1333 1333r 0054 0497 0848 1192 1250 1328 Product Description Iliac Crest Wedge 6mm x 12mm Iliac Crest Wedge 6mm x 12mm Iliac Crest Wedge 7mm x 12mm Iliac Crest Wedge 7mm x 12mm Iliac Crest Wedge 8mm x 12mm Iliac Crest Wedge 8mm x 12mm Iliac Crest Wedge 9mm x 12mm Iliac Crest Wedge 9mm x 12mm Iliac Crest Wedge 10mm x 12mm Iliac Crest Wedge 10mm x 12mm Iliac Crest Wedge Iliac Crest Wedge Iliac Crest Wedge – Lumbar Fusion Iliac Crest Wedge - Lumbar Fusion *Thick Tricortical Wedge *Thick Tricortical Wedge Preservation Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Sterilization Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Aseptic Irradiate Aseptic Irradiated Category Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Common Graft Utilization: Spinal Surgery Features / Benefits: Various Sizes Available * W > 2cm, H > 2cm, L > 2.5cm The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 54 of 68 Spine – Neuro BONE PLUG W/ CORTICAL END Product Code 1243 1639 0527 1149 0023 1150 0683 1153 0024 0489 0025 0490 0266 1151 Product Description Bone Plug 8mm Bone Plug 8mm Bone Plug 10mm Bone Plug 10mm Bone Plug 12mm Bone Plug 12mm Bone Plug 13mm Bone Plug 13mm Bone Plug 14mm Bone Plug 14mm Bone Plug 16mm Bone Plug 16mm Bone Plug 18mm Bone Plug 18mm Preservation Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Sterilization Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Category Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Base Bone Common Graft Utilization: Anterior Cervical Fusion Features / Benefits: Various lengths available The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 55 of 68 Spine - Neuro PATELLA WEDGE Product Code 1606 1607 Product Description Patella Wedge Patella Wedge Preservation Sterilization Category Freeze Dried Freeze Dried Aseptic Irradiated Base Bone Base Bone Common Graft Utilization: Spine Surgery Features / Benefits: W = 13-15mm, L = 22-30mm The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 56 of 68 Spine - Neuro DURA MATER Product Code Product Description Preservation Sterilization Category 0001 0002 0003 0004 0655 Dura Mater – Small Dura Mater – Medium Dura Mater – Large Dura Mater – Whole Dura Mater – Patch Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Ethylene Oxide Ethylene Oxide Ethylene Oxide Ethylene Oxide Ethylene Oxide Dura Dura Dura Dura Dura Common Graft Utilization: Craniotomy/Duraplasty, Dural Replacement, Hernia Repair, Spine Key Features & Benefits: Small: 31 - 50 cm2 Medium: 51 - 99 cm2 Large: ≥100 cm2 Whole: >120 cm2 Patch: 8-30 cm2 The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 57 of 68 OsteoArticular – Oncology Division Total Joints ELBOW Product Code Product Description Preservation Sterilization Category 0280 0080 Whole Elbow – Left Whole Elbow – Right Cryopreserved Cryopreserved Aseptic Aseptic OsteoArticular OsteoArticular Common Graft Utilization: Joint Replacement Features / Benefits: May be patient matched The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 58 of 68 OsteoArticular – Oncology Division Total Joints DISTAL FEMUR Product Code 0082 0081 Product Description Distal Femur w/ Ligaments – Left Distal Femur w/ Ligaments – Right Preservation Sterilization Category Cryopreserved Aseptic OsteoArticular Cryopreserved Aseptic OsteoArticular Common Graft Utilization: Joint replacements, Joint revision Features / Benefits: May be patient matched. Soft tissue attachments L = min 2cm The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 59 of 68 OsteoArticular – Oncology Division Total Joints HEMIPELVIS Product Code Product Description Preservation Sterilization Category 0101 0100 0325 3031r 0324 *Hemi-Pelvis – Left *Hemi-Pelvis – Right Hemi-Pelvis – Left Hemi-Pelvis – Left Hemi-Pelvis – Right Cryopreserved Cryopreserved Fresh Frozen Fresh Frozen Fresh Frozen Aseptic Aseptic Aseptic Irradiated Aseptic OsteoArticular OsteoArticular OsteoArticular OsteoArticular OsteoArticular Common Graft Utilization: Tumor resection, Joint replacement Features / Benefits: May be patient Matched *Soft tissue attachments L = min 2cm The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 60 of 68 OsteoArticular – Oncology Division Total Joints SCAPULA Product Code 0331 0636 0089 0635 1241 1431 1242 1432 1538 1486 Product Description Scapula – Left Scapula w/ Humerus – Left Scapula – Right Scapula w/ Humerus – Right Scapula – Right Scapula – Right Scapula – Left Scapula – Left Scapula w/ Humerus – Left Scapula w/ Humerus – Right Preservation Cryopreserved Cryopreserved Cryopreserved Cryopreserved Fresh Frozen Fresh Frozen Fresh Frozen Fresh Frozen Fresh Frozen Fresh Frozen Sterilization Aseptic Aseptic Aseptic Aseptic Aseptic Irradiated Aseptic Irradiated Irradiated Irradiated Category OsteoArticular OsteoArticular OsteoArticular OsteoArticular OsteoArticular OsteoArticular OsteoArticular OsteoArticular OsteoAritcular OsteoArticular Common Graft Utilization: Tumor resection, joint replacement Features /Benefits: May be patient matched The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 61 of 68 Oral & Maxillofacial RIB Product Code Product Description Preservation Sterilization Category 0158 1193 0129 Rib Rib Rib - Demineralized Freeze Dried Freeze Dried Freeze Dried Aseptic Irradiated Aseptic Base Bone Base Bone Base Bone Common Graft Utilization: Plastic Surgery, Reconstructive Surgery Features / Benefits: L > 8cm W = min 1cm The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 62 of 68 Oral & Maxillofacial MANDIBLE Product Code Product Description Preservation 0632 Mandible ETO Freeze Dried 0630 0631 Hemi-Mandible ETO – Right Hemi-mandible ETO – Left Freeze Dried Freeze Dried Sterilization Ethylene Oxide Ethylene Oxide Ethylene Oxide Category Oral-Maxillofacial Oral-Maxillofacial Oral-Maxillofacial Common Graft Utilization: Correction of Ridge Defects, Facial Reconstruction, Mandible Replacement Features / Benefits: The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 63 of 68 Oral & Maxillofacial MANDIBULAR & MAXILLA (M&M) BLOCKS Product Code Product Description Preservation Sterilization Category 1507 1523 1491 1522 1508 1565 M&M Block – Small M&M Block – Small M&M Block – Medium M&M Block – Medium M&M Block – Large M&M Block – Large Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Freeze Dried Aseptic Irradiated Aseptic Irradiated Aseptic Irradiated Oral-Maxillofacial Oral-Maxillofacial Oral-Maxillofacial Oral-Maxillofacial Oral-Maxillofacial Oral-Maxillofacial Common Graft Utilization: Correction of Ridge Defects Key Features & Benefits: Small: W = 10-12mm, L = 15-20mm, H= 8-10mm Medium: W = 16-18mm, L = 15-20mm, H = 8-10mm Large: W = 20-22mm, L= 20-25mm, H = 8-10mm The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 64 of 68 Fresh FEMUR CONDYLE Product Code 0776 0772 0760 0771 0774 0815 Product Description Lateral Femur Condyle – Left Lateral Femur Condyle – Right Medial Femur Condyle – Left Medial Femur Condyle – Right Whole Femur Condyle – Left Whole Femur Condyle – Right Preservation Fresh Fresh Fresh Fresh Fresh Fresh Sterilization Aseptic Aseptic Aseptic Aseptic Aseptic Aseptic Category Fresh Fresh Fresh Fresh Fresh Fresh Common Graft Utilization: Cartilage Replacement, Articular Resurfacing Features / Benefits: May be patient matched The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 65 of 68 Fresh MENISCUS W/ PLATEAU Product Code Product Description Preservation Sterilization Category 0326 Meniscus w/ Plateau – Left Fresh Aseptic Fresh 0782 Meniscus w/ Plateau – Right Fresh Aseptic Fresh Common Graft Utilization: Cartilage Replacement, Articular Resurfacing Key Features & Benefits: May be patient matched The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 66 of 68 Fresh ANKLE EN BLOC & TALUS Product Code 1283 1282 0805 0798 0702 0701 Product Description Ankle en bloc- Left Ankle en bloc - Right Talus – Left Talus – Right Talus – Left Talus – Right Preservation Fresh Fresh Fresh Fresh Cryopreserved Cryopreserved Sterilization Aseptic Aseptic Aseptic Aseptic Aseptic Aseptic Category Fresh Fresh Fresh Fresh OsteoArticular OsteoArticular Common Graft Utilization: Cartilage Replacement, Articular Resurfacing, Joint Replacement Key Features & Benefits: May be patient matched Total L =12cm including talus, calcaneous, tibia and fibula The University of Miami Tissue Bank (UMTB) has distributed tissue for transplantation for over 40 years. Since 1970, there have been no reports or observations of disease transmission. UMTB’s aseptic processing technique provides a minimally manipulated allograft which does not affect the biomechanical or osteoinductive properties of the tissue – the closest to an autograft. All data has been reviewed by a Medical Director or Associate Medical Director (licensed physician) and the allograft has been deemed suitable for transplantation. Page 67 of 68 UMTB provides the safest and most effective allografts: The University of Miami Tissue Bank was established in the early 1970’s and has provided safe and effective musculoskeletal grafts and skin for transplantation without interruption or significant incident since its inception. The University of Miami Tissue Bank has never felt compelled to treat tissues with chemicals or irradiation because we make extraordinary efforts to ensure aseptic procurement and processing to protect the biologic activity of the graft. We always ask the question, is secondary sterilization of biologic tissue progressive or regressive? Does the margin of “safety” that it provides make up for the decrement in biologic activity? Does it substitute for poor donor selection or sloppy procurement? We believe that the American Association of Tissue Banks (AATB) has adopted appropriate guidelines for Tissue Banking in the United States and the University of Miami is a proud member of this organization. Does your tissue come from an AATB accredited tissue bank? We believe that a careful medical and social history is vitally important in identifying suitable donors and preventing potential disease transmission. University of Miami retrievals are done under the supervision of a licensed physician who performs a careful examination of the donor and assures aseptic tissue handling. Bacteriologic surveillance begins with tissue procurement and continues throughout every component of processing and packaging. While others may feel compelled to pre treat grafts in detergents and peroxides then terminally sterilize them for whatever reason, we do not. The use of detergents and peroxides may reduce bacterial contamination in retrieved tissues however; we have demonstrated diminished biologic activity in tissues exposed to chemicals such as peroxide. A whiter graft is not a better graft and a sterile graft may not be biologically active. For this reason, we maintain that appropriate donor selection, careful medical supervision and aseptic processing are vital to ensure both graft safety and clinical efficacy. We fervently believe that the combination of careful donor selection, supervised procurement and aseptic processing produces ideal safe and effective tissue for transplantation. Our reputation and record support this. H. Thomas Temple, M.D. Director, University of Miami Tissue Bank Page 68 of 68