regenerex™ ringloc®+
Transcription
regenerex™ ringloc®+
clinically proven material. advanced porous technology. Regenerex ringloc + ™ ® Modular Acetabular System RingLoc +: Next Generation Cup Features ® Building on the success of unparalleled RingLoc® technology, the new RingLoc®+ shell design offers next generation cup features paired with advanced Regenerex™ porous titanium construct. Extended rim Designed to prevent soft tissue entrapment between shell and liner Regenerex™ Porous Titanium Construct Unites clinical history of titanium with an enhanced interconnecting pore structure for rapid bone ingrowth. Un-lock/re-lock mechanism Allows for easy disassembly without damaging the liner** Solid Limited hole Large dome hole Designed for ease of insertion Multi-hole **Any time the liner is removed, it is recommended that the locking ring be removed and replaced with a new one. If the liner is damaged in any way, a new liner should be utilized. 1 RingLoc : Unparalleled locking technology ® Biomet’s RingLoc® acetabular components have redefined the standard of acetabular technology. Testing by independent laboratories has rated RingLoc® technology among the highest in terms of push-out, lever-out and congruity of the implant as well as the lowest in micromotion.2–5 Unparalleled RingLoc® locking technology Achieves maximum push-out and lever-out strength with lowest micromotion of independently tested competitive systems2–5 Fully congruent design Maximizes congruency at the liner-to-shell interface to help minimize micromotion 2 Volumetric Wear1 5 million cycles on a hip simulator 28mm head size 60 53.3 50 Six or eight tabs create an interference fit with the notches on the liner to provide for maximum rotational stability and minimum micromotion Volumetric Wear Rate mm3/106 Cycles Anti-rotational tabs 40 29.4 30 20 10 0 0.24 Non-HXLPE ArComXL® HXLPE E-Poly™ HXLPE Ultra-low wear with large heads Combine with E-Poly™ HXLPE for the optimal combination of fixation and low wear. 40mm E-Poly™ liners demonstrated 95% lower wear than 36mm clinically proven ArCom® liners6 3 versatile modular design featuring Regenerex porous titanium construct ™ Regenerex™ Porous Titanium Construct is a revolutionary technology engineered for rapid bone ingrowth by uniting the proven clinical history of titanium with an enhanced interconnecting pore structure. Integrated with Biomet’s unparalleled RingLoc® technology, only the Regenerex™ RingLoc®+ Modular Shell offers new next generation RingLoc®+ cup features, which have been engineered to meet the needs of the orthopedic community. Rapid bone integration Initial stability • Two weeks after insertion, Regenerex™ implants • 16% rougher than Trabecular Metal,™ 6 the initial displayed bony integration and vascularization. • In similar canine studies, Regenerex material ™ scratch-fit, stability and fixation of Regenerex™ implants is well-suited for acetabular reconstruction. demonstrated more rapid ingrowth than Zimmer’s Trabecular Metal.™6 BONE INGROWTH1,6 Average Roughness (Ra) 2500 100 100 2079.2 80 2000 40 60 40 Regenerex™ material6,7 Trabecular Metal ™5 20 0 20 Microinch % Bone in Void Area % Bone in Void Area 80 60 2485.6 1500 1000 No testing data available 2 Weeks 4 Weeks 16 Weeks 26 Weeks 52 Weeks 500 0 2 Weeks 4 Weeks 16 Weeks 26 Weeks 52 Weeks 0 4 Regenerex ™ 6 Trabecular Metal ™ 6 Strong, yet flexible • 300% stronger than Trabecular Metal™ under compressive loads1, which reduces the risk of material failure. • Maintains a compressive modulus similar to cancellous bone. Peak compressive stress 300 compressive modulus 20 270 18 250 15 157 GPa MPa 200 150 10 100 50 50 5 2 21 0 Cortical Bone8,9 Cancellous Regenerex™ 6 Trabecular Bone8,9 Metal™10 0 Cortical Bone8,9 1.9 Cancellous Regenerex™ 6 Bone8,9 1.5 Trabecular Metal™10 5 RingLoc technology: Proven after 15 years of clinical use ® Maximum Motion Any Sensor, Any Condition 200 Various forces including toggling, levering and rotation are present 150 component life and help reduce potential debris generation, the shell-to-liner locking mechanism must be sound. Independent labs have consistently rated Biomet’s RingLoc® cups among the best. • Proven to be a superior locking mechanism for polyethylene Micrometers during normal acetabular kinematics. To extend acetabular 100 50 liners2–5 • High strength of the locking mechanism helps prevent liner disassociation from the shell • Fully supported liner for even stress distribution • Lowest micromotion of all tested systems to help eliminate debris generation 6 0 Biomet Ringloc® Smith & Nephew Reflection® Zimmer Trilogy® Data derived from Fehring TK, Smith SE, Braun ER, Mobley CE, Wang PL, Griffin WL: Motion at the Modular Acetabular Interface: A Competitive Study. Scientific Exhibit presented at the American Academy of Orthopaedic Surgeons. 62nd Annual Meeting. Atlanta, GA. 1996. Strength of the locking mechanism to help prevent liner disassociation from the shell System Name Initial Push-Out Initial Lever-Out Zimmer Trilogy® 722+ 408+ Biomet Ringloc® 660+ 660+ DePuy Duraloc® 663 647 Smith & Nephew Reflection® 65 92 0 100 200 300 400 500 600 700 800 0 100 200 300 400 500 600 700 800 Torque [in-lbf] Force [lbf] Trodonsky, S. et al.: Performance Characteristics of Two-Piece Acetabular Cups. Scientific Exhibit presented at the American Academy of Orthopaedic Surgeons. 59th Annual Meeting. San Francisco, CA. 1992. Trodonsky, S. et al.: Performance Characteristics of Two-Piece Acetabular Cups Series II. Scientific Exhibit presented at the American Academy of Orthopaedic Surgeons. 62nd Annual Meeting. Atlanta, GA. 1996. This data is the property of the Orthopaedic Research Laboratories of the Mt. Sinai Medical Center, Cleveland Ohio. The reproduction and distribution of this data are restricted. Support of the liner leading to even stress distribution to help improve liner life System Name Percent (%) of Unsupported Polyethylene Contact Area of Supported Polyethylene (sq. cm) Smith & Nephew Reflection® 13.5 24.1 Biomet Ringloc® 15.4 21.1 Zimmer Trilogy® 27.6 20.8 DePuy Duraloc® 34.1 16.7 0 5 10 15 20 25 30 35 0 5 10 15 20 25 Data derived from Rosner BI, Postak PD, Greenwald AS: Cup Liner Conformity of Modular Acetabular Designs. Scientific Exhibit presented at the American Academy of Orthopaedic Surgeons. 61st Annual Meeting. Orlando, FL. 1995. Data derived from Rosner BI, Postak PD, Greenwald AS: Cup/Liner Incongruity of Two Piece Acetabular Designs: Implications in the Generation Polyethylene Debris. Scientific Exhibit presented at the American Academy of Orthopaedic Surgeons. 60th Annual Meeting. New Orleans, LA. 1994. This data is the property of the Orthopaedic Research Laboratories of the Mt. Sinai Medical Center, Cleveland Ohio. The reproduction and distribution of this data are restricted. 7 versatility when you need it most… Multiple augment options • Designed to help maximize acetabular stability • Available in 12 sizes with multiple screw holes • Augments can be stacked for complex reconstruction • Ideal option for complicated revision surgery Multiple liner configurations • Available in… 8 Max-Rom™ Liner 10-Degree Liner Hi-Wall Liner +5mm Hi-Wall Liner Ultra-low wear with large heads • Combine with E-Poly™ HXLPE for the optimum combination of fixation and low wear • 40mm E-Poly™ liners demonstrated 95% lower wear than 36mm ArCom® liners6 Maximum resistance to dislocation • Combine with Biomet’s Freedom® Constrained Liner for patients at high dislocation risk • Allows for 110 degrees range of motion • Multiple liner options References 1. Data on file at Biomet. Bench test results not necessarily indicative of clinical performance. 2. Fehring, T.K. et al. Motion at the Modular Acetabular Interface: A Competitive Study. Scientific Exhibit presented at the American Academy of Orthopaedic Surgeons. 62nd Annual Meeting. Atlanta, GA. 1996. 3. Rosner, B.I. et al. Cup Liner Conformity of Modular Acetabular Designs. Scientific Exhibit presented at the American Academy of Orthopaedic Surgeons. 61st Annual Meeting. Orlando, FL. 1995. 4. Rosner, B.I. et al. Cup/Liner Incongruity of Two Piece Acetabular Designs: Implications in the Generation of Polyethylene Debris. Scientific Exhibit presented at the American Academy of Orthopaedic Surgeons. 60th Annual Meeting. New Orleans, LA. 1994. 5. Trodonsky, S. et al. Performance Characteristics of Two-piece Acetabular Cups. Scientific Exhibit presented at the American Academy of Orthopaedic Surgeons. 59th Annual Meeting. San Francisco, CA. 1992. 6. Data on file at Biomet. Testing done on animal models. 7. Bobyn, J.D. et al. Characteristics of Bone Ingrowth and Interface Mechanics of a New Porous Tantalum Biomaterial. Journal of Bone and Joint Surgery (British). 81-B(5): 907, 1999. 8. Keaveny, T.M. and Hayes, M.C. Bone, Volume 7: Bone Growth – B. B. Hall BL (Ed). CRC Press. Boca Raton, FL. 285–344, 1992. 9. Wirtz, D.C. et al. Critical Evaluation of Known Bone Material Properties to Realize Anisotropic FE-simulation of the Proximal Femur. Journal of Biomechanics. 33(10): 1325–30, 2000. 10. Zardiackas, L.D. et al. Structure, Metallurgy and Mechanical Properties of a Porous Tantalum Foam. University of Mississippi Medical Center. 2000. All trademarks belong to Biomet Manufacturing Corp. unless otherwise noted. Trabecular Metal™ and Trilogy® are trademarks of Zimmer, Inc. Duraloc® is a registered trademark of DePuy. Reflection® is a registered trademark of Richards Smith & Nephew, Inc. For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert and Biomet’s website. This material is intended for the sole use and benefit of the Biomet sales force and physicians. It is not to be redistributed, duplicated or disclosed without the express written consent of Biomet. P.O. Box 587, Warsaw, IN 46581-0587 • 800.348.9500 ext. 1501 ©2007 Biomet Orthopedics, Inc. All Rights Reserved • www.biomet.com BOI0052.0 • REV083107