Distributed by Bone Bank Allografts

Transcription

Distributed by Bone Bank Allografts
Dear Valued Customer:
On behalf of Bone Bank Allografts, we appreciate you taking the time to review this customer
manual. It was designed to be a strong resource for you.
The manual provides background information on our allografts, safety and processing procedures,
as well as some of the common surgical indications. This information is provided for reference
purposes only and is not intended to prescribe medical care.
Bone Bank Allografts is committed to honoring the gracious gift of donation by providing the
medical community with safe, high quality surgical solutions.
For your convenience, you can also access this information at our website at www.bonebank.com.
We greatly appreciate your business and if you ever have any questions, please do not hesitate to
contact our sales team or me directly at (800) 397-0088. It is always our great pleasure to assist you.
Warmest Regards,
Joe M. Mims, President
Bone Bank Allografts
4808 Research Drive
San Antonio, TX 78240
(800)397-0088
[email protected]
www.bonebank.com
An AATB certified tissue bank
STERILE HUMAN TISSUE ALLOGRAFTS
TABLE OF CONTENTS
About Bone Bank Allografts ……...………………................................................................ page 3
Allograft Processing ……...…………………............................................................................ page 5
An Introduction to Allografts ……............................................................................................. page 9
SteriGraft™ Soft Tissue Allografts ……………………………….………….... page 13
Whole Patellar Tendon with Quadricep ……………………….…….…..……. page 13
Hemi Patellar Tendon ………………...…………………………….………… page 13
Pre-Shaped Patellar Tendon 10 mm …...………………………….…….…….. page 13
Achilles Tendon without Bone Block …….………………...…………...…….. page 14
Achilles Tendon with Bone Block …….………………………………...…….. page 14
Pre-Shaped Achilles Tendon 10mm …..………………………………...…….. page 14
Gracilis Tendon …………..……………………………………….….………. page 15
Semitendinosus Tendon ……….……………………………….……….…….. page 15
Semitendinosus - Gracilis Bundle …..……………………….….……….…….. page 15
Tibialis Tendon Anterior ………..……………………….………..…….…….. page 16
Tibialis Tendon Posterior ……………………………….……….……….…….. page 16
Peroneus Longus Tendon …..……….………………………….……….…….. page 16
Fascia Lata …………………………………………………………..….…….. page 17
Pericardium …..……………………………………………………..….…….. page 18
Costal Cartilage ……………………………………………………...….…….. page 18
SteriGraft™ Traditional Bone Allografts …….………………………….…….. page 19
Cancellous Block ………………….…………….…………………………….. page 19
Cancellous Crushed 1 - 4 mm ………………..……….…………...…..….…….. page 19
Cancellous Crushed 4 – 10 mm ……………..……….………….…...……..….. page 20
Cancellous Cubes 5 mm ………………….…..………………….…………….. page 20
Cortical - Cancellous Crushed 1 - 4 mm ……..……………………….….…….. page 21
Cortical - Cancellous Crushed 4 - 10 mm ……...….………………………...….. page 21
Ilium Tricortical Block ……………………………….……………………….. page 22
Ilium Tricortical Strip ….…………………………….……………………….. page 22
Ilium Bicortical Strip ………...…………………….……………....….……….. page 23
Ilium Bicortical Plug ………………………………….…....…………….…….. page 23
Unicortical Dowel …………….………………………………...……….…….. page 24
Cortical - Cancellous Struts ………………………….………………….…….. page 24
Cortical Struts …………………………………..…...…………….……….….. page 24
Rib Section …….……………………………………………...……….……... page 25
Patella Block ………………… …………............................................…….…….. page 25
CONTINUED - See top of next page for traditional & specialty products
Page 1 | www.bonebank.com | 1-800-397-0088
SteriGraft™ Traditional Bone Allografts (continued) …..…..….………….... page 26
Cortical Plate …………………………………………………….…….……… page 26
Fibula Shaft …………………..………………....……………...….…….…….. page 27
Tibia Whole …………………………………...………….………....….….….. page 28
Tibia Section …………………………………...………….………..….….….. page 28
Femoral Head ……….….…………….………….……………........…….…….. page 29
Femur Whole ……….….…………….………….……………........…….…….. page 29
Femur Proximal …………………………………………...……………….….. page 29
Femur Distal …………..………………………………………...……….…….. page 30
Femur Shaft Split …....………………………….…………………….….…….. page 30
Femur Section ………..………………………………………………...….….. page 31
Humerus Proximal ……………………………………………….…….….….. page 32
Humerus Distal ………….……………………………………….…….….….. page 32
Humerus Section …………...…….……………………………….…….….….. page 32
SteriFuse™ DBM …………………………………………………………..…….. page 33
SteriGraft™ Precision Specialty Allografts ……………………………..……..
SteriGraft™ Cervical ACF …………………………………...……….………..
SteriGraft™ Cortical Ring Castled and Lordosed 5° ………………….………..
SteriGraft™ PLIF 9 x 23 mm ………………………...……………….………..
SteriGraft™ ALIF Castled and Lordosed 7° and 12° ………………….………..
SteriGraft™ Dense Cancellous Block ……………….……………..…….……...
SteriGraft™ Unicortical Dense Cancellous Block ……………………………....
SteriGraft™ Lordotic Bone Wedge ……..……...……………………………….
SteriSorb™ Osteoconductive Sponge Allografts ..…...…..........................………...
SteriFlex™ Wrappable Bone Allografts .....………….………………….....……..
page 34
page 34
page 35
page 36
page 37
page 38
page 39
page 40
page 41
page 42
SteriGraft™ Dental Bone Powder (Mineralized & Demineralized) …...….. page 43
SteriShield™ Protective Amnion Patch ……………………….……….…….. page 44
Ordering Information ……...……..………………………………….………..………. page 45
Copyright 2012, Bone Bank Allografts. All rights reserved. (LB-064 R00.)
www.bonebank.com | 1-800-397-0088 | Page 2
ABOUT BONE BANK ALLOGRAFTS
Our Mission:
Is to enhance the quality of patient care by providing safe, high quality
allograft tissues to health care professionals for both transplant and research.
The History of Bone Bank Allografts
Bone Bank Allografts was founded in 1993 in response to a growing need for allograft tissue in South
Texas. Hospitals and surgeons needed a reliable, consistent source of quality allografts for use in
neurologic, orthopedic, oral-maxillofacial, and urologic surgeries. Bone Bank Allografts became that
source for bone, soft tissues and cartilage. Since 1993, Bone Bank Allografts’ distribution network has
grown to cover Texas, the country and the globe, fulfilling surgical needs for allograft tissue in more than
175,000 successful transplantations.
Located in San Antonio, Texas, Bone Bank Allografts is dedicated to a just, equitable and fair
distribution of cadaveric tissue to surgeons, hospitals, surgicenters and dental offices. Over the years,
our customers have come to rely on the superior quality of our tissue products as well as the unmatched
service of our well trained, certified Tissue Bank Specialists (CTBS) and our knowledgeable distribution
staff.
With accreditation from the American Association of Tissue Banks (AATB), registration with the U.S.
Food and Drug Administration (FDA) and compliance with the FDA’s Good Tissue Practices, Bone
Bank Allografts continues to pursue our mission: To enhance the quality of patient care by providing safe, high
quality allograft tissues to health care professionals for transplant and research. Most recently, Bone Bank Allografts
has taken the next important step in tissue banking by developing a powerful partnership with Texas
Human Biologics (THB) in order to process donated human tissue.
www.bonebank.com | 1-800-397-0088 | Page 4 LB-064 R00
Our Partnership with Texas Human Biologics
In 2006, Bone Bank Allografts recognized a significant need for a higher allograft processing standard.
In accordance with its mission, BBA constructed a state of the art facility for processing donated human
tissue.
Located in the Texas Research Park, currently dedicated to the
pursuit of biotechnology research and development, Texas
Human Biologics emerged in February 2007. THB was
designed and built in full compliance with environmental
conditions and standards required for the processing of human
tissue as set forth by the AATB and FDA. The result of this
groundbreaking partnership is the SteriGraft™ line of allograft
products. SteriGraft™ products are manufactured using the
fully validated, trademarked GraftShield™ method resulting in
precision crafted tissues for application in a vast array of surgical
procedures.
Licenses and Certifications
Bone Bank Allografts is accredited by the American Association of Tissue Banks (AATB) and follows
procedures for tissue banking based on strict standards. Additionally, Bone Bank Allografts is licensed
by and follows regulations set forth by the States of New York, California, Maryland, Oregon, and
Florida. Bone Bank Allografts adheres to the federal laws and guidelines of the United States Food and
Drug Administration (FDA), Centers for Disease Control (CDC) and United States Public Health
Service (USPHS).
Copies of related licenses and certifications are available for download from our website at
www.bonebank.com.
LB-064 R00
PROPRIETARY ALLOGRAFT PROCESSING
Overview of the GraftShield™ Process
While the options for surgical musculoskeletal repair continue to expand, a growing number of surgeons
worldwide choose bone and soft tissue allografts as a safe, effective and convenient surgical option.
Allografts bearing the SteriGraft™ label fulfill the discriminating surgeon’s desire to extend extraordinary
patient care. Our superior level of allograft processing begins with rigorous Donor Screening and
meticulous Donor Recovery Procedures, Certified Laboratory
Testing, validated Tissue Cleansing, Sterile Packaging, and a
meticulous Quality Assurance & Documentation system that ranks
second to none.
The GraftShield™ allograft processing system is designed to set an entirely new standard in allograft
sterilization. This system offers scientifically validated tissue sterilization (validated to SAL 10-6 in
accordance with ISO 11137-2 Method 1) which virtually eliminates the risk of bacterial disease
transmission.
Donor Screening & Reviews
Our donor screening and recovery partners meet or exceed all industry standards set forth by the
American Association of Tissue Banks. Following donation consent, our extensive evaluation process
includes:
•
•
•
A detailed potential donor screening and evaluation process to review medical history as well
as any lifestyle or behavioral issues which may disqualify donation.
Individuals identified with risk factors for or clinical evidence of
relevant communicable diseases and disease agents (RCDADS)
such as AIDS, viral Hepatitis, Sepsis, etc., are ruled out as potential
donors or are later disqualified if subsequent investigation reveals
high risk markers.
An on-site review of the potential donor’s relevant medical records
to evaluate other rule out conditions.
A physical assessment of each donor candidate just prior to tissue
recovery to confirm donor identity, evaluate the accuracy of medical
and social history collected, and to look for signs/symptoms of
other disqualifying conditions or risk factors.
Donor Recovery & Processing
Extreme care is taken to ensure donor tissues are recovered, processed and packaged appropriately so
that the donor gift materializes in the most beneficial way for transplant recipients. We believe the best
way to honor donors is to maximize the number of individuals helped through their generous donation.
Maximizing the gift while safeguarding the public trust by providing safe, sterile human allograft tissue is
the primary goal of our processing efforts.
Stringent tissue donor screening, recovery, storage and shipping guidelines are followed to best preserve
the allografts for their intended function.
LB-064 R00
Certified Laboratory Testing
In accordance with FDA and AATB Standards, donor specimens are collected and sent to an
independent laboratory certified under the Clinical Laboratory Improvement Amendments of 1988
(CLIA) to test for the following infectious diseases and antibody or antigen markers listed below:
Human Immunodeficiency Virus Type I Ab
HIV I Antibody
HIV I Nucleic Acid Test
Human Immunodeficiency Virus Type II Ab
HIV II Antibody
Human T-Lymphotrophic Virus Type I
HTLV I Antibody
Human T-Lymphotrophic Virus Type II
HTLV II Antibody
Hepatitis B Virus
HBc Antibody (total)
HBs Antigen
Hepatitis C Virus
HCV Antibody
HCV Nucleic Acid Test
Syphilis
Rapid Plasma Reagin Test
FTA Confirmation
All donors are evaluated for hemodilution which could potentially affect test results. Only a licensed
physician determines final donor suitability.
GraftCleanse™ Tissue Cleansing
The GraftShield™ process requires aseptic handling of all tissue throughout processing and is based on a
scientifically validated sterilization method which results in a Sterility Assurance Level (SAL) of 10-6 in
accordance with ISO 11137-2 Method 1. This validated process is designed to protect the biomechanical
properties of each allograft while virtually eliminating patient risk.
During processing, tissues are treated with the GraftCleanse™
process which includes chemical and physical cleaning
procedures that reduce the bone marrow and lipid elements
associated with normal human tissue.
LB-064 R00
Tissue Processing
Our proprietary GraftSheild™ processing system was developed to
offer the following advantages:
▪ Validated GraftCleanse™ tissue cleansing method
▪ Custom machinery designed exclusively by THB for tissue
manufacturing and sterilization between each donor case
▪ Load strength testing
▪ Controlled exposure to freeze/thaw cycles
Sterile Packaging
The GraftShield™ Advantage
•
•
•
•
Sterile human allograft
tissues
Final package sterilization
Proprietary cleansing
processes
Bone Bank Allografts meets
the exacting FDA
regulations and AATB
standards
SteriGraft™ bone and soft tissue allografts are packaged with extreme care to preserve the validated
sterile nature of the tissue. Packaging steps are cautiously taken to ensure that our allografts arrive to the
end user in a manner that promises the highest patient safety and allograft quality.
The following details outline our packaging advantages:
•
•
•
•
•
•
•
•
Double Tyvek pouches and easy to read labeling
Outer package which provides a durable moisture barrier designed
to accommodate both ultra-low and ambient temperature storage
Sterile inner pouch designed for easy delivery to the sterile field
Terminal sterilization of product in its final packaging
Validated three year expiration dating
Included product insert which provides details regarding donor
screening, testing and tissue processing
Transplant record and multiple tissue ID barcode labels for
operating room staff
SteriGraft™ box allows for convenient stacking and storage
Quality Assurance
Our donor tracking, documentation, tissue processing, allograft packaging, storage and shipping
processes ensure the availability of safe, high quality allografts. A three-level pre-processing review is
performed by our highly trained Quality Assurance staff and Medical Director. The following items are
carefully reviewed and documented:
•
•
•
•
Donor qualification
Medical/behavioral risk profile
Review of consent/authorization to recover tissues for transplantation
Review of recovery process/time frames/reconciliation of refrigeration times/recovery site
assessment/recovery sequence
LB-064 R00
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Completion of recovery record
Receipt/reconciliation of tissue recovered
Supplies/materials used in recovery/ lot numbers and expiration dates
Blood sample assessment/qualification
Infectious disease testing results
Procurement microbiology results
Information sharing with other agencies who participated
in recovery or receipt of recovered tissues
Pathology/autopsy results if performed
Tissue receipt records
o Verification of Shipment parameters
o Reconciliation of tissues shipped vs. received
Processing records
o SOP requirements have been met
o Supplies used
o Visual product / packaging inspection
o Traceability of tissues received
o Irradiation sterilization parameters
o Residual Moisture results acceptable
Completion of Quality Assurance investigations
Completion of Production technical review
Inventory data entry
Final labeling
Our Processing Partner Facility
Located in the Texas Research Park in San Antonio, Texas Human Biologics
(THB) has recently opened its new state-of-the-art human tissue processing
center. The facility was designed and built to be in full compliance with
environmental condition requirements for handling human tissue. All human
tissues are handled in an ultra clean environment.
Specialty features include:
o Continuous sheet, seam welded cove base flooring
o Gasketed, sealed, and washable ceilings
o Full sheet glued Fiberglass Reinforced Polyester (FRP), seam sealed walls
o Point of passage, magnehelic gauges for continuous monitoring of clean
room zone pressures
o Fully adjustable High Efficiency Particulate Air (HEPA) filter air
handling system
o Magnetic door interlocks for facility security and air pressure
maintenance
o Validated ethylene oxide sterilization of supplies and equipment
o Validated steam sterilization of supplies and equipment
LB-064 R00
An Introduction to Allografts
An allograft is transplantable tissue which comes from a human
donor and is placed into a different recipient. This tissue is
typically processed and sterilized, then used in grafting surgeries
to repair damaged bones or ligaments. Conversely, an autograft
is tissue which is harvested from the patient’s own body and
then transplanted into another area needing repair. Both
allografts and autografts are also contrasted to xenografts which
are tissue transplants of animal origin intended for human
recipients. The SteriGraft™ line from Bone Bank Allografts features human allografts.
The Sterigraft™ line features validated sterile bone and soft tissue allografts for transplantation in a
variety of surgical settings. Be assured that we have worked very hard to provide the safest and highest
quality allograft tissue available for your upcoming surgery.
We should not overlook the circumstances through which these allografts are available for your surgeons
and patients. This superior surgical option is available because a donor and donor family made the
decision to make a very generous donation. We believe this gracious gift should not be taken for granted.
Many allograft recipients show their appreciation for the
gift they have received by signing their own donor card,
encouraging their family to do the same, and by
becoming active in donation groups and causes. Even
though one donor can touch the lives of over 100 other
people, the need for life saving and life enhancing tissues
and organs still exceeds the amount provided by donors.
Consider becoming a donor hero!
Contact us to find out how your hospital may benefit
from becoming a Bone Bank Allografts donor referral
partner.
LB-064 R00
Allograft Advantages Over Other Grafting Options
Allografts offer a significant advantage over other grafting options. The following information highlights
the advantages of allografts over each of the alternate grafting methods:
ALTERNATE GRAFTING METHOD: Autograft
Autografting is a process in which tissue is harvested from a patient and then transplanted to another
area needing repair in the same individual. Allografts offer the following advantages over autografts:
•
Autografting actually involves two surgical
procedures which increases the overall length
of the surgery – allograft surgeries are faster
•
Autografting increases the length of time the
patient is under anesthesia, increasing the risk
of the surgery
•
Autografting poses several possible risks
associated with the donor site which may result
in infection, extended pain, additional scarring
and weakness (because a small portion of the
patient’s tissue has been permanently removed)
•
Patients may not have a sufficient amount of tissue available to accomplish the goal of the
surgery
•
Allograft tissues can be pre-shaped specifically for individual surgical applications
ALTERNATE GRAFTING METHOD: Xenograft
A xenograft is transplantable tissue which comes from an animal and is intended for a human recipient.
Allografts offer the following advantages over xenografts:
•
LB-064 R00
Reduced risk of rejection related to a donor of the same species (allograft) compared to potential
immunity issues related to donation from a different species (xenograft)
ALTERNATE GRAFTING METHOD: Synthetic / Metal
Many products exist in the market which consist of metal or synthetic materials. When compared to
these options, allografts have the following advantages:
•
Nothing short of natural bone mimics the structural and biological properties of human allograft
bone.
•
Most allografts used in transplantation will eventually be replaced with recipient tissue as it
incorporates into the patient's body structures. Allografts, in conjunction with the patient’s
native tissue, stimulate the cascade of normal tissue regeneration events, ultimately achieving
stable incorporation. Metal and synthetic implants frequently achieve immediate stabilization
and begin a cascade of degeneration events which can ultimately lead to implant or anatomical
structure instability.
•
Many bone and connective tissue surgical treatments require implants to possess weight bearing
properties – allografts are strong and can be used in weight bearing applications to help reestablish a more natural support. More importantly, the structures implanted will often remodel
into the patient's own tissue. While metals and synthetics can accomplish the load bearing
characteristics, they usually never achieve full incorporation.
When considering all factors, allografts are clearly the superior surgical alternative to surgeons and
patients alike.
Medical Indications
The SteriGraft™ line features a complete selection of traditional bone and connective tissue allografts
which can be applied in neurologic, orthopeadic, sports medicine, dental/cranio facial, and urologic
surgeries. Products in this line range from cancellous bone to femoral shafts, fibula sections, tricortical
blocks, and more. Below is a list of many medical indications which commonly make use of allograft
products in their surgeries.
Disclaimer: The following information is provided to discuss the medical indications in which
allograft tissues may be used. This is provided for very general informational purposes and in no
way represents medical advice. We are a medical manufacturing company, not medical
practitioners. Please use the information only in the way it is intended.
General Orthopaedics
• Osteo Defects
• Acetabular Repair
• Total Joint Revision
• Bone Void Filler
LB-064 R00
Medical Indications (continued)
Sports Medicine
• Osteochondral Defects
• Knee Ligament Repairs (ACL, PCL, MCL, and LCL)
• Meniscal Transplantation
• OC Transplantation
• Soft Tissue Reattachment
Spine Surgeries
• Anterior Cervical Fusion (ACF)
• Posterior Cervical Fusion (PCF)
• Corpectemy with Fusion
• Posterior Lumbar Interbody Fusion (PLIF)
• Anterior Lumbar Interbody Fusion (ALIF)
Oncology
• Tumor Resection
Limb Salvage
• Matching
• Joint Transplant
Hand & Wrist Surgeries
• Fusions
• Carpal Fractures
Foot/Ankle Surgery
• Metatarsal Osteotomy
• Metatarsal Fractures
• Fusions
• Malleolar Fractures
Oral / Maxillofacial Surgery
• Dental Implants
• Reconstruction
• Tumor Resection
• Alveolar Ridge Augmentation
Urology
• Bladder Neck Suspension
• Pelvic Floor Recast
Copyright 2012, Bone Bank Allografts. All Rights Reserved.
LB-064 R00
STERILE SOFT TISSUE ALLOGRAFTS
SteriGraft™ – Hemi / Whole Patellar Tendon
Product
Code
890
891
892
Description
Whole Patellar
Tendon with
Quadricep
Whole Patellar
Tendon without
Quadricep
Hemi Patellar
Tendon
Size &
Measurements
X x W x Z mm
T > 9 mm
Y > 23 mm
Q > 30 mm
X x W x Z mm
T > 9 mm
Y > 23 mm
X mm
W > 10 mm
Z > 10 mm
T > 9 mm
Y > 23 mm
892 Hemi patella
tendon with quad
Source: Tibia, patella and patellar ligament
Preservation Method: Frozen
Containers must be stored at -40°C or colder
Measurement Description: X = inner tendon length. W = tendon
width. Z = tibial bone block width. T = tibial bone block thickness.
Y = tibial bone block length. Q = quad length (if present).
Common Surgical Applications: Reconstruction of knee ligaments
SteriGraft™ – Pre-Shaped Patellar Tendon 10 mm
Product
Code
8922
Description
Pre-Shaped
Patellar Tendon
10 mm
Size &
Measurements
X mm
W > 10 mm
DT = 10 - 10.5 mm
Y > 23 mm
DP = 10 - 10.5 mm
Z > 23 mm
Source, Preservation Method, Surgical Applications: Same as above
Measurement Description: (X) = inner tendon length. (W) = tendon
width. (DT) = tibial bone dowel diameter. (Y) = length of the tibial
bone dowel. (DP) = patellar bone dowel diameter. (Z) = length of
the patellar bone dowel.
LB-064 R00
SteriGraft™ – Achilles Tendon with & w/o Bone Block
Product
Code
809
893
Description
Achilles Tendon
without Bone
Block
Achilles Tendon
with Bone Block
Size &
Measurements
L > 240 mm
See diagram
L > 180 mm
W > 10 mm
Z > 10 mm
T > 15 mm
Y > 23 mm
893 Achilles Tendon
with Bone Block
Source: Achilles Tendon
Measurement Description: (L) = tendon length. (W) = tendon
width. (Z) = calcaneal bone block width. (T) = calcaneal bone
block thickness. (Y) = calcaneal bone block length.
Common Surgical Applications: Reconstruction of rotator
cuffs, reconstruction of knee ligaments and Achilles tendon
repair
SteriGraft™ – Pre-Shaped Achilles Tendon 10 mm
Product
Code
8933
Description
Pre-Shaped
Achilles Tendon
10 mm
Size &
Measurements
L > 180 mm
W > 10 mm
D = 10 – 10.5 mm
Y > 23 mm
Source: Achilles Tendon
Measurement Description: (L) = tendon length. (W) = tendon width.
(D) = calcaneal bone dowel diameter. (Y) = length of the calcaneal
bone dowel.
Common Surgical Applications: Reconstruction of rotator cuffs,
reconstruction of knee ligaments and Achilles tendon repair
LB-064 R00
SteriGraft™– Gracilis Tendon
Product
Code
894
Description
Gracilis Tendon
Size &
Measurements
L > 230 mm
D > 5 mm
Source: Gracilis Tendon
Measurement Description: W = midpoint width. L = length.
D = folded diameter.
Common Surgical Applications: Reconstruction of knee, ankle
wrist or shoulder ligaments
SteriGraft™ – Semitendinosus Tendon
Product
Code
895
Description
Semitendinosus
Tendon
Size &
Measurements
L > 230 mm
D > 5 mm
Source: Semitendinosus Tendon
Preservation Method, Measurement Description & Common
Surgical Applications: Same as above
SteriGraft™ – Semitendinosus - Gracilis Bundle
Product
Code
8954
Description
Semitendinosus Gracilis Bundle
Size &
Measurements
L > 230 mm
D > 8 mm (both
tendons folded together
as a single unit)
LB-064 R00
SteriGraft™ – Tibialis Tendon Anterior
Product
Code
896
Description
Tibialis Tendon
Anterior
Size &
Measurements
L> 230 mm
D > 6 mm
Source: Anterior Tibialis Tendon
Measurement Description: W = midpoint width. L = length.
D = folded diameter.
Common Surgical Applications: Reconstruction of knee, ankle,
wrist or shoulder ligaments
SteriGraft™ – Tibialis Tendon Posterior
Product
Code
897
Description
Tibialis Tendon
Posterior
Size &
Measurements
L > 230 mm
D > 6 mm
Source: Posterior Tibialis Tendon
SteriGraft™ – Peroneus Longus Tendon
Product
Code
995
Description
Peroneus
Longus Tendon
Size &
Measurements
L > 230 mm
D > 6 mm
Source: Peroneus Longus Tendon
LB-064 R00
SteriGraft™ - Fascia Lata
Product
Code
701
702
703
704
Description
Fascia Lata,
40 x 60 mm
Fascia Lata,
50 x 80 mm
Fascia Lata,
60 x 100 mm
Fascia Lata,
70 x > 150 mm
Size &
Measurements
W = 40 mm
L = 60 mm
W = 50 mm
L = 80 mm
W = 60 mm
L = 100 mm
W = 70 mm
L > 150 mm
Source: Lateral surface of the thigh
Preservation Method: Lyophilized
Containers must be stored at ambient temperature
Description: Fascia may or may not include the iliotibial bands. The
width (W) will be perpendicular to the grain, and the length (L) will
be taken along the grain.
Common Surgical Applications: Ligament reconstruction, repair of
craniotomy and dural defects, eye lid repair, or bladder suspension
SteriGraft™ - Fascia Lata - Frozen
Product
Code
791
792
793
794
Description
Fascia Lata,
40 x 60 mm – Frozen
Fascia Lata,
50 x 80 mm – Frozen
Fascia Lata,
60 x 100 mm - Frozen
Fascia Lata,
70 x >150 mm - Frozen
Size &
Measurements
W = 40 mm
L = 60 mm
W = 50 mm
L = 80 mm
W = 60 mm
L = 100 mm
W = 70 mm
L > 150 mm
Source, Description, Common Surgical Application: Same as above
LB-064 R00
SteriGraft™ – Pericardium
Product
Code
720
721
722
723
724
Description
Pericardium, 15 x 20 mm
Size &
Measurements
15 x 20 mm (+/- 0.5 mm)
20 x 30 mm (+/- 0.5 mm)
30 x 40 mm (+/- 0.5 mm)
60 x 60 mm (+/- 5 mm)
80 x 80 mm (+/- 5 mm)
Source: Pericardial sac
Common Surgical Applications: Pericardial defect, dura matter repair,
and periodontal reconstruction
SteriGraft™ - Costal Cartilage - Saline
Product
Code
280
290
Description
Costal Cartilage,
30 - 59 mm
FROZEN
Costal Cartilage,
> 60 mm
FROZEN
Size &
Measurements
W > 10 mm
L = 30 - 59 mm
W > 10 mm
L > 60mm
Source: Rib
Common Surgical Applications: Maxillofacial, nasal or ear
reconstruction
LB-064 R00
STERILE TRADITIONAL BONE ALLOGRAFTS
SteriGraft™ – Cancellous Block 30 x 15 x 15 mm
Product
Code
303
Description
Cancellous Block
30 x 15 x 15 mm
Size &
Measurements
L = 30 mm
W = 15 mm
T = 15 mm
Source: Proximal / distal tibia, distal femur, femoral head
or humeral head
Common Surgical Applications: Spinal fusion or general
orthopaedic reconstruction
SteriGraft™ – Cancellous Crushed 1 – 4 mm
Product
Code
316
309
308
306
307
Description
Cancellous Crushed
1 – 4 mm, 5 cc
Cancellous Crushed
1 – 4 mm, 10 cc
Cancellous Crushed
1 – 4 mm, 15 cc
Cancellous Crushed
1 – 4 mm, 30 cc
Cancellous Crushed
1 – 4 mm, 60 cc
Size &
Measurements
Vol = 5 cc
Vol = 10 cc
Vol = 15 cc
Vol = 30 cc
Vol = 60 cc
Source: Proximal and distal ends of long bones, ilium,
calcaneus or talus
Common Surgical Applications: Filling of bone defects, prosthetic or bone graft augmentation for spinal
fusion, oral and maxillofacial, ankle and foot, or general orthopaedic reconstruction
LB-064 R00
SteriGraft™ – Cancellous Crushed 4 - 10 mm
Product
Code
317
312
313
310
Description
Size &
Measurements
Cancellous Crushed
4 – 10 mm, 10 cc
Cancellous Crushed,
4 – 10 mm, 15 cc
Cancellous Crushed,
4 – 10 mm, 30 cc
Cancellous Crushed,
4 – 10 mm, 60 cc
Vol = 10 cc
Vol = 15 cc
Vol = 30 cc
Vol = 60 cc
calcaneus or talus
Common Surgical Applications: Same as above
SteriGraft™– Cancellous Cubes 5 mm
Product
Code
318
315
304
305
Description
Cancellous Cubes
5 mm, 10 cc
Cancellous Cubes
5 mm, 15 cc
Cancellous Cubes
5 mm, 30 cc
Cancellous Cubes
5 mm, 60 cc
Size &
Measurements
Vol = 10 cc
Vol = 15 cc
Vol = 30 cc
Vol = 60 cc
femur, calcaneus or talus
LB-064 R00
SteriGraft™ – Cortical - Cancellous Crushed 1 - 4 mm
Product
Code
449
458
464
465
397
398
385
Description
Cortical - Cancellous Crushed
1-4 mm, 5 cc
1-4 mm, 10 cc
1-4 mm, 15 cc
1-4 mm, 30 cc
1-4 mm, 15 cc, FROZN
Size &
Measurements
Vol = 5 cc
Vol = 10 cc
Vol = 15 cc
Vol = 30 cc
Vol = 15 cc
FROZEN
Vol = 30 cc
FROZEN
Vol = 60 cc
FROZEN
Source: Proximal and distal ends of long bones, ilium, calcaneus or talus
Preservation Method: Lyophilized (Except as noted: Frozen item containers must be stored at -40°C or colder)
Lyophilized item containers must be stored at ambient temperature
Common Surgical Applications: Filling of bone void defects, augments prosthetic or other implants used
for spinal fusion, oral and maxillofacial, ankle and foot, or general orthopaedic reconstruction
SteriGraft™ – Cortical - Cancellous Crushed 4 - 10 mm
Product
Code
459
467
468
Description
Cortical - Cancellous
Crushed 4 – 10 mm, 10 cc
Size &
Measurements
Vol = 10 cc
Vol = 15 cc
Vol = 30 cc
Source: Same as above
Containers must be stored at ambient temperature and checked for the presence of a seal.
Common Surgical Applications: Same as above
LB-064 R00
SteriGraft™ – Ilium Tricortical Block
Product
Code
103
124
125
126
127
128
114
101
116
115
Description
Ilium Tricortical
Block, 5 mm
Ilium Tricortical
Block, 6 mm
Ilium Tricortical
Block, 7 mm
Ilium Tricortical
Block, 8 mm
Ilium Tricortical
Block, 9 mm
Ilium Tricortical
Block, 10 mm
Ilium Tricortical
Block, 12 mm
Ilium Tricortical
Block, 15 mm
Ilium Tricortical
Block, 18 mm
Tricortical Block,
25 mm
Size &
Measurements
W = 5 mm L = 14–30 mm
T1 > 10 mm T2 > 7 mm
W = 6 mm L = 14–30 mm
T1 > 10 mm T2 > 7 mm
W = 7 mm L = 14–30 mm
T1 > 10 mm T2 > 7 mm
W = 8 mm L = 14–30 mm
T1 > 10 mm T2 > 7 mm
W = 9 mm L = 14–30 mm
T1 > 10 mm T2 > 7 mm
W = 10 mm L = 14–30 mm
T1 > 10 mm T2 > 7 mm
W = 12 mm L = 25–30 mm
T1 > 10 mm T2 > 7 mm
W = 15 mm L = 25–30 mm
T1 > 10 mm T2 > 7 mm
W = 18 mm L = 25–30 mm
T1 > 10 mm T2 > 7 mm
W = 25 mm L = 25–30 mm
T1 > 15 mm T2 > 15 mm
Source: Iliac crest
Common Surgical Applications: Spinal fusion or general orthopaedic
reconstruction
SteriGraft™ – Ilium Tricortical Strip
Product
Description
Code
118
Ilium Tricortical Strip,
40 mm
121
50 mm
123
60 mm
Size &
Measurements
W = 40 mm L = 25–30 mm
T1 > 10 mm T2 > 7 mm
W = 50 mm L = 25–30 mm
T1 > 10 mm T2 > 7 mm
W = 60 mm L = 25–30 mm
T1 > 10 mm T2 > 7 mm
LB-064 R00
SteriGraft™ – Ilium Bicortical Strip
Product
Code
504
Description
Ilium Bicortical
Strip, 40 mm
505
Ilium Bicortical
Strip, 45 mm
506
Ilium Bicortical
Strip, 50 mm
507
Ilium Bicortical
Strip, 55 mm
508
Ilium Bicortical
Strip, 60 mm
Size &
Measurements
L = 38 - 42 mm
W = 19 - 25 mm
T1 > 9 mm T2 > 5 mm
L = 43 - 47 mm
W = 19 - 25 mm
T1 > 9 mm T2 > 5 mm
L = 48 - 52 mm
W = 19 - 25 mm
T1 > 9 mm T2 > 5 mm
L = 53 - 57 mm
W = 19 - 25 mm
T1 > 9 mm T2 > 5 mm
L = 58 - 62 mm
W = 19 - 25 mm
T1 > 9 mm T2 > 5 mm
Source: Ilium
Common Surgical Applications: Spin al fusion/corpectomy
or general orthopaedic reconstruction
SteriGraft™ – Ilium Bicortical Plug
Product
Code
111
112
113
Description
Ilium Bicortical Plug,
12 mm
14 mm
16 mm
Size &
Measurements
D = 12 mm
L = 10 - 14 mm
D = 14 mm
L = 10 - 14 mm
D = 16 mm
L = 10 - 14 mm
Source: Ilium
Common Surgical Applications: Spinal fusion
LB-064 R00
SteriGraft™ – Unicortical Dowel
Product
Code
201
202
203
204
Description
Unicortical Dowel,
12 mm
Unicortical Dowel,
14 mm
Unicortical Dowel,
16 mm
Unicortical Dowel,
18 mm
Size &
Measurements
D = 12 mm L > 25 mm
D = 14 mm L > 25 mm
D = 16 mm L > 25 mm
D = 18 mm L > 25 mm
Source: Proximal and distal ends of long bones
Common Surgical Applications: Spinal fusion, ORIF or general
SteriGraft™ – Strut
Product
Code
109
404
401
402
Description
Cortical - Cancellous Struts,
50 mm (5 / pkg)
Cortical - Cancellous Strut >
50 mm (1 / pkg)
Cortical Struts, 50 mm
(5 / pkg)
Cortical Struts, 100 mm
(5 / pkg)
Size &
Measurements
L = 49 - 51 mm
W = 4 - 6 mm
T = 4 - 8 mm
Same as above
L = 49 - 51 mm
W = 4 - 6 mm
T = 4 – 8 mm
L = 99 - 101 mm
W = 4 - 6 mm
T = 4 - 8 mm
Source: Tibia, femur or ilium
Common Surgical Applications: Spinal fusion, oral
and maxillofacial reconstruction or general orthopaedic
reconstruction
LB-064 R00
SteriGraft™ – Rib Section
Product
Code
501
Description
Size &
Measurements
Varies - see
diagram
Rib Section
Source: Rib
Common Surgical Applications: Oral and maxillofacial
reconstruction
SteriGraft™ – Patella Block
Product
Code
Description
100
Patella Block
Size &
Measurements
W = 18 - 30 mm
T1 > 9 mm; T2 > 5 mm
L = varies, see diagram
Source: Center of the patella
Common Surgical Applications: Spinal fusion, tibial tubercle
elevation/osteotomy or general orthopaedic reconstruction
LB-064 R00
SteriGraft™ – Cortical Plate
Product
Code
440
Description
Cortical Plate
10 x 100 mm
441
Cortical Plate
10 x 150 mm
442
Cortical Plate
10 x 200 mm
443
Cortical Plate
20 x 100 mm
444
Cortical Plate
20 x 150 mm
445
Cortical Plate
20 x 200 mm
Size &
Measurements
L = 98 - 102 mm
W = 9 - 11 mm
T > 3 mm
L = 148 - 152 mm
W = 9 - 11 mm
T > 3 mm
L = 198 - 202 mm
W = 9 - 11 mm
T > 3 mm
L = 98 - 102 mm
W = 19 - 21 mm
T > 3 mm
L = 148 - 152 mm
W = 19 - 21 mm
T > 3 mm
L = 198 - 202 mm
W = 19 - 21 mm
T > 3 mm
Source: Femur or tibia
Common Surgical Applications: Hip revision or general orthopaedic
reconstruction
SteriGraft™ – Cortical Plate – Frozen
Product
Code
599
Description
Cortical Plate 20 x 200 mm
- Frozen
Size &
Measurements
L = 198 - 202 mm W = 19 - 21 mm T > 3 mm
Source & Common Surgical Applications: Same as above
LB-064 R00
SteriGraft™ – Fibula Shaft
Product
Code
426
432
433
425
434
435
Description
Fibula Shaft, 40 mm
Fibula Shaft, 60 mm
Fibula Shaft, 80 mm
Fibula Shaft, 100 mm
Size &
Measurements
L= 38 - 42 mm D> 10 mm
L= 58 - 62 mm D> 10 mm
L= 78 - 82 mm D>10 mm
L= 98 - 102 mm D> 10 mm
L= 118 - 122 mm D> 10 mm
L= 148 - 152 mm D> 10 mm
Distributed as individual grafts
Source: Fibula
Common Surgical Applications: Cervical fusion/corpectomy
or general orthopaedic reconstruction
SteriGraft™ – Fibula Shaft - Frozen
Product
Code
496
497
498
495
499
Description
Fibula Shaft, 60 mm - Frozen
Fibula Shaft, 80 mm – Frozen
Fibula Shaft, 150 mm - Frozen
Size &
Measurements
L= 58 - 62 mm D> 10 mm
L= 78 - 82 mm D>10 mm
L= 98 - 102 mm D> 10 mm
L= 118 - 122 mm D> 10 mm
L= 148 - 152 mm D> 10 mm
Source, Common Surgical Applications: Same as above
LB-064 R00
SteriGraft™ – Tibia Whole
Product
Code
490
Description
Tibia Whole
Size &
Measurements
Condyle to Condyle
Source and Common Surgical Applications: Same as below
SteriGraft™ – Tibia Section
Product
Code
406
407
Description
Tibia Section,
80 – 100 mm
Tibia Section,
101 - 200 mm
Size &
Measurements
L = 80 - 100 mm
D = mm (varies)
L = 101 - 200 mm
D = mm (varies)
Source: Tibia
Common Surgical Applications: Spinal fusion or general
SteriGraft™ – Tibia Section - Frozen
Product
Code
494
Description
Tibia Section,
100 - 200 mm Frozen
Size &
Measurements
L = 100 - 200 mm
D = mm (varies)
ID = mm (varies)
Source and Common Surgical Applications: Same as above
LB-064 R00
SteriGraft™ – Femoral Head
Product
Description
Code
692
Femoral Head - Frozen
Size &
Measurements
D > 45 mm
Common Surgical Applications: Hip revision or general
SteriGraft™ – Femur Whole
Product
Code
581
582
591
592
Description
Femur Whole Left Frozen
Femur Whole Left
w/o head - Frozen
Femur Whole Right Frozen
Femur Whole Right
w/o head - Frozen
Size &
Measurements
Condyle to
Condyle
Condyle to
Condyle
SteriGraft™ – Femur Proximal
Product
Code
593
594
Description
Femur Proximal Left
w/Head
Femur Proximal Right
w/Head
Size &
Measurements
L > 200 mm
(see diagram)
L > 200 mm
(see diagram)
Source: Femur
Common Surgical Applications: Hip revision
LB-064 R00
SteriGraft™ – Femur Distal
Product
Code
695
696
Description
Size &
Measurements
L > 200 mm
W = mm (varies)
W’ = mm (varies)
D’ = mm (varies)
L > 200 mm
W = mm (varies)
W’ = mm (varies)
D’ = mm (varies)
Femur Distal with
Shaft Left
Femur Distal with
Shaft Right
Source: Distal Femur
Common Surgical Applications: General orthopaedic
reconstruction
SteriGraft™ – Femur Shaft Split
Product
Code
645
650
Description
Femur Shaft Split
(2 pcs)
Femur Shaft Split
(1 pc)
Size &
Measurements
L > 200 mm
W = mm (varies)
L > 200 mm
W = mm (varies)
Source: Femur
Common Surgical Applications: Hip revision or general orthopaedic
reconstruction
SteriGraft™ – Femur Shaft Split - Frozen
Product
Code
796
Description
Femur Shaft Split
(1 pc)
Size &
Measurements
L > 200 mm
LB-064 R00
25
SteriGraft™ – Femur Section
Product
Code
604
Description
Femur Section,
100 mm
Femur Section,
150 mm
Femur Section,
200 mm
Femur Section,
250 mm
605
606
609
Size &
Measurements
L = 98 - 102 mm
D > 20 mm
L = 148 - 152 mm
D > 20 mm
L = 198 - 202 mm
D > 20 mm
L = 248 - 252 mm
D > 20 mm
Source: Femur
Common Surgical Applications: Lumbar fusion, hip revision or general
SteriGraft™ – Femur Section (Frozen)
Product
Code
699
697
694
Description
Femur Section, 150 mm - Frozen
Size &
Measurements
L = 148 - 152 mm D > 20 mm
L = 198 - 202 mm D > 20 mm
L = 248 - 252 mm D > 20 mm
Source & Common Surgical Applications: Same as above
LB-064 R00
SteriGraft™ – Humerus - Frozen
Product
Code
291
Description
Proximal Humerus
Right – Frozen
292
Proximal Humerus
Left - Frozen
298
Distal Humerus
RT/LT - Frozen
Size &
Measurements
L > 160 mm
D = mm (varies)
D2 = mm (varies)
See diagram
L > 160 mm
D = mm (varies)
D2 = mm (varies)
See diagram
L > 150 mm
W’ = mm (varies)
W = mm (varies)
D’ = mm (varies)
Drawing for
291 / 292
Source: Humerus
Common Surgical Applications: ORIF or total shoulder reconstruction
SteriGraft™ – Humerus Section – Frozen
Product
Code
293
Description
Humerus Section Frozen
Size &
Measurements
L > 148 mm; D > 15 mm
D2 = mm (varies)
Source & Common Surgical Applications: Same as above.
SteriGraft
Product
Code
923
™
– Humerus Section – Freeze Dried
Description
Humerus Section
Size &
Measurements
L > 148 mm; D > 15 mm
D2 = mm (varies)
Drawings for
298
Drawing for
293 / 923
Source & Common Surgical Applications: Same as above.
LB-064 R00
DEMINERALIZED BONE MATRIX
DBM Putty and Crunch
Product Code
JHG-007P
JHG-01P
JHG-02P
JHG-05P
JHG-10P
JHG-01C
JHG-02C
JHG-05C
JHG-10C
Description / Volume
DBM Putty 0.7cc
DBM Putty 1.0cc
DBM Putty 2.5cc
DBM Putty 5.0cc
DBM Putty 10.0cc
DBM Crunch 1.0cc
DBM Crunch 2.5cc
DBM Crunch 5.0cc
DBM Crunch 10.0cc
Now available from Bone Bank Allografts, a DBM Putty and
Crunch with the following features:
* 100% Human DBM bone void filler
* No filler / carrier necessary due to a unique processing
method
* Both putty and crunch are flowable and formable
* Does not wash away easily
* Produced under strict c-GMP and ISO 13485 practices
* Recovery and screening performed according to AATB and FDA guidelines
* Terminally sterilized using validated gamma irradiation
* 2 year shelf life
Manufactured by Berkley Advanced Biomaterials and distributed by International Biologics
LB-064 R00
STERILE PRECISION SPECIALTY ALLOGRAFTS
SteriGraft™ – Cervical ACF 11 x 14 mm
Product
Code
70505
70506
70507
70508
70509
Description
Cervical ACF 5 mm
11 x 14 mm 5° Lordosed
Cervical ACF 6 mm
Cervical ACF 7 mm
Cervical ACF 8 mm
Cervical ACF 9 mm
Size &
Measurements
H=5 mm W=14 mm
L=11 mm
H=6 mm W=14 mm
L=11 mm
H=7 mm W=14 mm
L=11 mm
H=8 mm W=14 mm
L=11 mm
H=9 mm W=14 mm
L=11 mm
* Cervical ACF is also available in parallel version
Description: Constructed of 100% human cortical bone. Computer designed and cut for high precision,
tolerances, and consistency. Designed to work with universal inserters. Unique “V groove” surface
serration pattern for improved traction.
Common Surgical Applications: Cervical spinal fusion
LB-064 R00
SteriGraft™ – Cortical Ring Castled and Lordosed 5°
Product
Code
70005
70006
70007
70008
70009
70010
70011
Description
Size & Measurements
Cortical Ring Castled
and Lordosed 5°, 5 mm
Cortical Ring Castled &
Lordosed 5°, 10 mm
Cortical Ring Castled &
Lordosed 5°, 11 mm
H = 5 mm W =13 mm
L = 11 mm
H = 6 mm W =13 mm
L = 11 mm
H = 7 mm W = 13 mm
L = 11 mm
H = 8 mm W = 13 mm
L = 11 mm
H = 9 mmW = 13 mm
L = 11 mm
H = 10 mm W = 13 mm
L = 11 mm
H = 11 mm W = 13 mm
L = 11 mm
L
Source: Radius or ulna
SteriGraft™ – Cortical Ring Castled
Product
Code
71005
71006
71007
71008
71009
71010
71011
Description
Size & Measurements
Cortical Ring Castled, 5 mm
H: 5mm (+0.3/-0.2) W: 13mm (+/-1.0mm) L: 11mm (+/-1.0mm)
H: 6mm (+0.3/-0.2) W: 13mm (+/-1.0mm) L: 11mm (+/-1.0mm)
H: 7mm (+0.3/-0.2) W: 13mm (+/-1.0mm) L: 11mm (+/-1.0mm)
H: 8mm (+0.3/-0.2) W: 13mm (+/-1.0mm) L: 11mm (+/-1.0mm)
H: 9mm (+0.3/-0.2) W: 13mm (+/-1.0mm) L: 11mm (+/-1.0mm)
H: 10mm (+0.3/-0.2) W: 13mm (+/-1.0mm) L: 11mm (+/-1.0mm)
H: 11mm (+0.3/-0.2) W: 13mm (+/-1.0mm) L: 11mm (+/-1.0mm)
LB-064 R00
SteriGraft™ – PLIF 9 x 23 mm
Product
Code
85007
85009
85011
85013
85015
Description
PLIF 9 x 23 mm 7 mm height
Size
H=7 mm
H=9 mm
H=11 mm
H=13 mm
H=15 mm
Description: Constructed of 100% human cortical bone. Computer
designed and cut for high precision, tolerances, and consistency.
Designed to work with universal inserters. Unique groove surface
Common Surgical Applications: Posterior lumbar interbody fusion
LB-064 R00
SteriGraft™ - ALIF 28 x 28 mm 7º and 12º Lordosed
Product
Code
80710
Description
ALIF 10 mm 28 x
28 mm 7º Lordosed
ALIF 12 mm 28 x
28 mm 7º Lordosed
ALIF 14 mm 28 x
28 mm 7º Lordosed
ALIF 16 mm 28 x
28 mm 7º Lordosed
ALIF 18 mm 28 x
28 mm 7º Lordosed
ALIF 20 mm 28 x
28 mm 7º Lordosed
Size &
Measurements
H=10mm, L=28 mm
W = 28 mm
H=12mm, L=28 mm
W = 28 mm
H=14mm, L=28 mm
W = 28 mm
H=16mm, L=28 mm
W = 28 mm
H=18mm, L=28 mm
W = 28 mm
H=20mm, L=28 mm
W = 28 mm
ALIF 10 mm 28 x
28 mm 12º Lordosed
ALIF 12 mm 28 x
28 mm 12º Lordosed
ALIF 14 mm 28 x
28 mm 12º Lordosed
ALIF 16 mm 28 x
28 mm 12º Lordosed
ALIF 18 mm 28 x
28 mm 12º Lordosed
ALIF 20 mm 28 x
28 mm 12º Lordosed
H=10mm, L=28 mm
W = 28 mm
H=12mm, L=28 mm
W = 28 mm
H=14mm, L=28 mm
W = 28 mm
H=16mm, L=28 mm
W = 28 mm
H=18mm, L=28 mm
W = 28 mm
H=20mm, L=28 mm
W = 28 mm
80712
80714
80716
80718
80720
81210
81212
81214
81216
81218
81220
Source: Femur
Description: Constructed of 100% human cortical bone. Computer designed and cut for high precision,
tolerances, and consistency. Designed to work with universal inserters. Unique “V groove” surface
Common Surgical Applications: Anterior lumbar interbody fusion
LB-064 R00
SteriGraft™ - Dense Cancellous Block 12 x 14 mm
Product
Code
72205
Description
Dense Cancellous Block
12 x 14 mm, 5 mm
72206
12 x 14 mm, 6 mm
72207
12 x 14 mm, 7 mm
72208
12 x 14 mm, 8 mm
72209
12 x 14 mm, 9 mm
72210
12 x 14 mm, 10 mm
72211
12 x 14 mm, 11 mm
Size &
Measurements
H = 5 mm
L = 12 mm
W = 14 mm
H = 6 mm
L = 12 mm
W = 14 mm
H = 7 mm
L = 12 mm
W = 14 mm
H = 8 mm
L = 12 mm
W = 14 mm
H = 9 mm
L = 12 mm
W = 14 mm
H = 10 mm
L = 12 mm
W = 14 mm
H = 11 mm
L = 12 mm
W = 14 mm
Source: Femoral head, patella, distal tibia, talus or calcaneus
LB-064 R00
SteriGraft™ - Unicortical Dense Cancellous Block 12 x 14 mm
Product
Code
71305
71306
71307
71308
71309
71310
71311
Description
Unicortical Dense Canc
Block 12 x 14 mm, 5 mm
Unicortical Dense Cancs
Block 12 x 14 mm , 11 mm
Size &
Measurements
H=5mm, L=12mm
W=14mm
H=6mm, L=12mm
W = 14 mm
H=7mm, L=12mm
W=14mm
H=8mm, L=12mm
W=14mm
H=9mm, L=12mm
W=14mm
H=10mm, L=12mm
W=14mm
H=11mm, L=12mm
W=14mm
Source: Femoral head, patella, distal tibia, talus or calcaneus
SteriGraft™ - Unicortical Dense Cancellous Block 12x14 Lordosed 5°
Product
Code
70305
70306
70307
70308
70309
70310
70311
Description
Unicortical Dense Canc Blk
12x14 Lordosed 5°, 5 mm
Size &
Measurements
H=5mm, L=12mm
W=14mm
H=6mm, L=12mm
W = 14 mm
H=7mm, L=12mm
W=14mm
H=8mm, L=12mm
W=14mm
H=9mm, L=12mm
W=14mm
H=10mm, L=12mm
W=14mm
H=11mm, L=12mm
W=14mm
LB-064 R00
SteriGraft™ – Unicortical Cancellous Lordotic Bone Wedge
Product
Code
340
341
Description
Unicortical
Cancellous Lordotic
Bone Wedge (Lg)
Unicortical
Cancellous Lordotic
Bone Wedge (Sm)
Size &
Measurements
H = 12 mm L = 38 mm
W = 22 mm (+/-1.0mm)
H = 6 mm L = 24 mm
W = 14 mm (+/-1.0mm)
Source: Ilium, talus, calcaneus, femoral condyles, proximal tibia, or patella
Common Surgical Applications: Foot / Ankle Reconstruction
SteriGraft™ – Lordotic Bone Wedge
Product
Code
330
331
Description
Lordotic Bone
Wedge (Lg)
Lordotic Bone
Wedge (Sm)
Size &
Measurements
H = 10 mm L = 50 mm
W = 40 mm (+/-0.5 mm)
H = 6 mm L = 24 mm
W = 14 mm (+/-0.5 mm)
Source: Ilium, talus, calcaneus, femoral condyles, proximal tibia, or patella
Common Surgical Applications: Foot / Ankle Reconstruction
LB-064 R00
SteriSorb™ - Osteoconductive Sponge Allografts
Product
Code
Description
Size &
Measurements
70808
70810
70812
70814
71800
71801
71802
71805
71810
71815
71830
75810
75815
75830
74810
74815
74818
74830
74840
74805
74801
74850
76810
76812
76814
SteriSorb™ Cube, 8 mm
SteriSorb™ Chips .5 cc
SteriSorb™ Chips 1 cc
SteriSorb™ Strip
SteriSorb™ Strip
SteriSorb™ Strip
SteriSorb™ Strip
SteriSorb™ Strip
SteriSorb™ Strip
SteriSorb™ Strip
SteriSorb™ Strip
SteriSorb™ Cranial Disc
8 x 8 x 8 mm
10 x 10 x 10 mm
12 x 12 x 12 mm
14 x 14 x 14 mm
1 - 4 mm particles
1 - 4 mm particles
1 - 4 mm particles
1 - 4 mm particles
1 - 4 mm particles
1 - 4 mm particles
1 - 4 mm particles
4 - 10 mm particles
4 - 10 mm particles
4 - 10 mm particles
10 x 20 x 5 mm
15 x 40 x 5 mm
15 x 20 x 5 mm
20 x 30 x 5 mm
25 x 40 x 5 mm
5 x 50 x 5 mm
10 x 50 x 5 mm
20 x 50 x 5 mm
10 x 5 mm
12 x 5 mm
14 x 5 mm
Source: Proximal and distal ends of long bones, ilium, calcaneus or talus
Preservation Method: Lyophilized - Containers must be stored at room
temperature
Description: 100% cancellous bone that is compressible, has wicking
characteristics, and maintains the biocompatibility of human bone. A new solution for
“tight space” bone voids, which assumes characteristics of a sponge by absorbing saline,
blood, or bone marrow aspirate. The graft compresses to 1/2 its original size (or less)
then expands back to its former size to secure a better fit. This gives the surgeon more
flexibility, decreases surgery time, reduces the potential for migration, and eliminates the
leaching commonly seen with puttys and gels. Encourages excellent osteoconductivity
and supports rapid vascularization of the allograft to incorporate the recipient’s natural
bone growth factors and stimulate new bone growth. Such rehydration of bone implants
has been discussed in the literature for years (Mulliken, Ann. Surg., 1981), but only
recently has technology allowed us to commercially produce such an innovative solution.
SteriSorb™ is sterilized with the GraftShield™ process for improved allograft safety.
Common Surgical Applications: Spinal fusion and general orthopaedic
surgeries; and dental reconstruction.
LB-064 R00
SteriFlex™ - Wrappable Bone Allografts
Product
Code
72825
72835
72850
72875
72810
73825
73835
73850
73875
Description
SteriFlex™, 15 x 25 mm
Size &
Measurements
W = 15 mm L = 25 mm
W = 15 mm L = 35 mm
W = 15 mm L = 50 mm
W = 15 mm L = 75 mm
W = 15 mm L = 100 mm
W = 20 mm L = 25 mm
W = 20 mm L = 35 mm
W = 20 mm L = 50 mm
W = 20 mm L = 75 mm
Source: Femur, tibia, ilium or humerus
Description: 100% cortical bone that can be bent, contoured, rolled,
trimmed, molded or sewn, making this flexible bone material incredibly
versatile in surgical settings. Maintains the structure, stability, and
osteoconductivity of human bone and stimulates new bone growth.
Rehydration of bone implants for such a desired use has been discussed in
the literature for years (Mulliken, Ann. Surg., 1981), but only recently has
technology allowed us to commercially produce such an innovative solution.
SteriFlex™ is sterilized with the GraftShield™ process for improved allograft
safety.
Common Surgical Applications: Orthopaedic, neurologic, dental /
maxillofacial, trauma and bone augmentation
LB-064 R00
STERILE BONE POWDER - DENTAL
SteriGraft™ – Mineralized and
Demineralized Bone Powder Dental
4M25025
Mineralized Cortical Bone Powder
Vol = .25cc
4M25050
Vol = .5cc
4M25100
Vol = 1cc
4M25200
Vol = 2cc
4M25250
Vol = 2.5cc
4M25500
Vol = 5cc
5M25050
Mineralized Cort/Canc Bone Powder
Vol = .5cc
5M25100
Vol = 1cc
5M25200
Vol = 2cc
5M25250
Vol = 2.5cc
5M25500
Vol = 5cc
6M25025
Demineralized Cortical Bone Powder
Vol = .25cc
6M25050
Vol = .5cc
6M25100
Vol = 1cc
6M25200
Vol = 2cc
6M25250
Vol = 2.5cc
6M25500
Vol = 5cc
7M25025
Demineralized Cort/Canc Bone Powder
Vol = .25cc
7M25050
Vol = .5cc
7M25100
Vol = 1cc
7M25200
Vol = 2cc
7M25250
Vol = 2.5cc
7M25500
Vol = 5cc
Common Surgical Applications: Bone grafting
applications in dental procedures
LB-064 R00
AMNION ALLOGRAFTS
SteriShield™ – Protective Amnion Patch
Product
Code
730
731
732
733
830
831
832
833
834
835
838
839
Description
SteriShield™ Single Layer
Protective Amnion Patch
Size &
Measurements
1 x 1 cm
SteriShield II™ Double Layer
2 x 2 cm
SteriShield™ Double Layer
Protective Amnion Disc
SteriShield™ Double Layer
Protective Amnion Disc
2 x 2 cm
4 x 4 cm
4 x 6 cm
1 x 1 cm
SteriShield II™ – Dual Layer Protective
Amnion Patch is shown above.
2 x 3 cm
4 x 4 cm
4 x 6 cm
4 x 8 cm
10 mm diameter
16 mm diameter
Source: Human placental tissues
Preservation Method: Desiccated - Containers must be stored at ambient, room temperature
Description: SteriShield™ protective amnion patches provide safe, natural protection for both
superficial and deep wounds, providing a physical cover for the wound bed, even in surgical sites.
Amnion has been shown to be readily accepted in tissue transplantation and does not lead to adverse
immune responses.
Common Surgical Applications: Spinal fusion and other orthopedic
surgeries, tendon / soft tissue procedures, podiatric surgeries,
dental surgeries, ophthalmology surgeries, cosmetic surgeries,
bariatric procedures, and burns or wound care treatments.
LB-064 R00
ORDERING INFORMATION
Contacting Us
Bone Bank Allografts is committed to meeting your needs for safe, high-quality musculoskeletal tissues
for transplantation. Our aim is to meet all product needs and surgery dates with our diverse selection of
available grafts. We are proud to be able to provide over 20,000 allografts per year for transplant
surgeries within the United States and internationally.
Our Certified Tissue Bank Specialists handle the distribution of tissues as well as address any concerns
regarding the tissue or the distribution process. A BBA Account Manager can be reached Monday
through Friday, between 8:00 a.m. and 5:00 p.m. CST, at (800) 397-0088 or at (210) 696-7616. A staff
member is always on call outside regular operating hours to respond to emergency orders and concerns
and will generally respond to your call within 15 minutes.
In addition, Bone Bank Allografts’ technical staff is available to answer questions, offer suggestions, or
discuss custom tissue needs. Our Executive Director and our Director of Quality Assurance are always
available to consult with surgeons or hospital personnel regarding allograft usage.
Client Services
4808 Research Drive
Main: 210-696-7616
Toll Free: 800-397-0088
Fax: 210-696-7609
Email: [email protected]
LB-064 R00
Placing an Order
When placing tissue orders, the following information is required:
• name of person placing order
• hospital name
• phone number
• purchase order number
• specific tissue type and size
• case date
• procedure to be performed
• surgeon name
Special Orders
Custom grafts may be discussed with the BBA Account Manager at any time. Texas Human Biologics,
our expert processing facility, can customize allografts to meet unique surgical needs. Contact your
Account Manager to coordinate a specific design to suit your surgeon and patients’ need. Please allow a
minimum of 4-6 weeks for custom orders.
We may also provide various bone and soft tissue products which are not featured in this catalog. These
items may not be readily available in our inventory but upon request, may be produced. Please contact
your Account Manager at Bone Bank Allografts to discuss your specific needs.
LB-064 R00
Delivery Options
Local Delivery Services (San Antonio, Texas)
Medcare Express Delivery Service (M.E.D.S.)
• 911 (45 minutes – 1 hour)
• STAT (1-2 hours)
• Routine (3-4 hours or by end of business day)
Cost: $25 (regardless of service)
Fed Ex Delivery Services
•
•
•
•
•
•
First Overnight delivered by 8-8:30am (where available)
Priority One delivered by 10:30am (by noon or 4:30 pm in remote areas)
Standard delivered by 3:30pm (4:30 pm in remote areas)
Two Day delivered on the 2nd business day by 4:30 pm
Express Saver delivered on the 3rd business day by 4:30 pm to a business (7 pm to residences)
Estimated freight costs (as of catalog publication date – call for current rates) are provided below:
Delivery Time
8:00 AM
10:30 AM
3:30 or 4:30 PM
Two Day (by 4:30)
Three Day (by 4:30/7)
Varies
Fed Ex Service
First Overnight
Priority One
Standard
Two Day
Express Saver
Saturday Delivery
Freeze Dried
Estimated Shipping
Cost*
$88.00
$62.00
$52.00
$42.00
$37.00
$25.00 (additional)
Frozen
Estimated Shipping
Cost*
$155.00
$95.00
NA
NA
NA
$25.00 (additional)
*Shipping estimates are subject to change without notice. Actual shipping charges will apply.
Estimates for frozen shipments are based on the amount of dry ice required to ship the package.
International Delivery Services - Contact us at 800-397-0088 for a quote of services available and
estimated shipping costs.
Storage Indications
Freeze-dried or air-dried allograft tissues should be stored at room temperature (approximately 20 to 24
degrees Centigrade). Frozen tissue should be stored at -40 degrees Centigrade or below. Short-term
frozen storage (six months or less) requires storage at -20 degrees Centigrade. If a frozen graft is thawed,
it can be stored up to 24-hours in a 1-6 degrees Centigrade refrigerator.
BBA shipping containers have been validated to maintain appropriate storage temperatures.
LB-064 R00
Returns / Credit Policy
Bone Bank Allografts’ mission is to provide only safe, high quality allograft tissues to health care
professionals. In an effort to meet these goals, Bone Bank Allografts will accept returned human
allograft tissue for exchange or credit provided the tissue has been consistently maintained, and the
following return procedures have been followed. General criteria for returning tissue are as follows:
No Frozen return requests will be accepted at any time.
No return requests for grafts shipped with a 6-month or shorter expiration will be
accepted.
No Freeze-dried return requests will be accepted after thirty (30) days from the invoice
date.
A Return Goods Authorization # must be received from a Bone Bank Allografts Account
Manager and clearly indicated on the outside of the package.
Human allograft tissue must be in its original, unopened and untampered container.
Original labeling must be legible, intact, and not defaced in any manner.
Human allograft tissue must be returned using shipping methods, containers and packing
materials in accordance with Bone Bank Allografts return procedures.
Human allograft tissue must be received in good condition at Bone Bank Allografts.
Freeze-Dried Tissue:
• Freeze-Dried and Saline preserved human allograft tissue must be stored and maintained at
ambient temperatures while at your facility.
• Freeze-dried human allograft tissue should be wrapped in bubble packaging or other material
that will reduce the risk of breakage, damage or puncture during shipment
• Freeze-dried human allograft tissue should be returned for delivery within 5 days from the
date you receive return authorization or the return will no longer be accepted.
Procedures for Returning Human Allograft Tissue
1. Call your Account Manager at 800-397-0088 to receive a Return Authorization Number (RA#).
You will need the serial numbers of the grafts you are returning, the storage information for each
graft, and a detailed reason for the return.
2. Clearly write the RA# on the outside of the package.
3. All returns must be addressed to:
Bone Bank Allografts Returns
4808 Research Drive
4. All returns must be shipped via a courier that offers tracking services. Contact your Account
Manager at 800-397-0088 with tracking number(s) for your return shipment.
Bone Bank Allografts reserves the right to refuse any return that has not met the conditions and
specifications of this policy. Some returns may be subject to further restrictions.
All returns are subject to a 20% restocking fee.
LB-064 R00

Distributed by Bone Bank Allografts

Transcription

Similar documents

Layzie, Krayzie, Bizzy

A message from Dr. Hilt Tatum, Jr. Contents

Maturation of Erythrocytes - Fall River Public Schools

ASBMR 09 Tibia Sedentarios - Poster

On Track April 2016

Brochure

Synthetic Bone Substitute

Institute of Orthopedic Research and Biomechanics, Center of

REJECTION STUDY OF CANCELOUS ALLOGRAFT IN