DEPUY ATTUNE KNEE SYSTEM

{0}------------------------------------------------ K101433 #1/6 | Submitted by: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, IN 46581<br>Phone: (574) 371-4923<br>Fax: (574) 371-4987 | DEC 10 2010 | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | Contact Person: | Nancy Friddle, Project Manager Regulatory Affairs | | | Date Prepared: | Aug 2, 2010 | | | Proprietary Name: | DePuy Attune™ Knee System | | | Common Name: | Total Knee Replacement Prosthesis | | | Classification Name: | 21 CFR 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-<br>constrained cemented prosthesis. Class II | | | Product Code: | JWH<br>OIY | | | Predicate Devices: | The DePuy Attune Knee System is substantially equivalent to currently marketed<br>devices including:<br>PFC Sigma® Knee System (cleared as the Darwin Knee System), K943462 Sigma Patella (cleared as the Darwin Knee System), K950010 PFC Cruciate Retaining Knee System, Size 1.5, K961685 Sigma Co-Cr Tibial Trays, K032151 Sigma XLK Tibial Inserts, K040166 Sigma CR 150 Femoral Components, K082500 Zimmer NexGen CR Knee System, K933785 AMK® Fixed Stem Tibial Tray, K922620 | | | Device Description: | The Attune™ femoral components are available in a cruciate retaining (CR)<br>version. The CR femoral components have an asymmetric trochlear groove and<br>are available in sizes 1-10 in right and left options. Sizes 3-6 are available in<br>standard and narrow options. The fixation surface is textured. It incorporates<br>two lugs (pegs) to provide additional stability and recessed cement pockets for<br>enhanced cement fixation. The Attune Femoral Components are manufactured<br>from cast Co-Cr-Mo alloy conforming to ASTM F75.<br><br>The Attune fixed bearing CR tibial insert is designed with a topography that, in<br>the sagittal view, consists of multiple radii. The sagittal anterior radii are tight<br>to aid in anterior constraint while the posterior radius is larger to allow rollback.<br>The Attune design allows for the retained posterior cruciate ligament and/or | | - {1}------------------------------------------------ 101433 #2/6 balanced posterior capsule to assist in appropriate rollback of the femur. The design offers minimal but appropriate constraint in the posterior direction for maximal rollback and full range of motion. The Attune fixed bearing CR tibial inserts are available in sizes 1-10 and in thicknesses of 5, 6, 7, 8, 10, 12, 14, 16, and 18mm. The inserts are manufactured from AOX ultra high molecular weight polvethvlene conforming to ASTM F648. The Attune tibial bases are available in sizes 1-10. The Attune tibial base fixation surface is textured. It incorporates a stem and keel to provide additional stability and recessed cement pockets for enhanced cement fixation. The Attune tibial base utilizes a central universal locking mechanism to capture the tibial insert. The Attune tibial bases are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. The Attune patellae are available in sizes 29, 32, 35, 38, and 41mm. The fixation surface incorporates 3 pegs to provide stability and recessed cement pockets for enhanced cement fixation. The patella components are manufactured from AOX ultra high molecular weight polyethylene conforming to ASTM F648. The Attune Knee System is designed to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knee flexion. Total knee replacement is intended to provide increased patient mobility and Intended Use: reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. The Attune Knee System is intended to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knee flexion. The DePuy Attune Knee System is intended for cemented use as a total knee Indications for Use: replacement system. Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. Technological As shown in the following tables, the technological characteristics of the Attune Characteristics: femoral components and tibial baseplates are similar to the predicate devices including design and CoCr material. The technological characteristics of the Attune patellae and tibial inserts are similar to the predicate devices in terms of design. The AOX material has also been proven to be similar to that of predicate materials. {2}------------------------------------------------ K101433*3/6 | Characteristic. | AttuneTM CR Femoral<br>Component | PFC Sigma CR<br>Femoral Component<br>(K943462, K961685), PFC<br>Sigma CR150 Femoral<br>Component (K082500), and<br>NexGen (K933785) | |---------------------|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Material | Cast Co-Cr-Mo alloy<br>conforming to ASTM F75 | Cast Co-Cr-Mo alloy<br>conforming to ASTM F75 | | Sizes | Sizes 1 to 10 standard, Left<br>and Right<br>Sizes 3-6 narrow, Left and<br>Right<br>Proportional Sizing | Sigma:<br>CR Size 1.5, Left and Right<br>(K961685)<br>CR Sizes 2 - 6, Left and Right<br>(K943462)<br>CR150 Sizes 1.5 - 6, Left and<br>Right (K082500)<br>Constant Sizing<br>NexGen:<br>CR sizes A micro - H macro<br>(K933785) | | Fixation<br>Surface | Cemented | Cemented | | Characteristic | Attune™ Fixed Bearing<br>Tibial Inserts | Sigma XLK Curved and<br>PLI Tibial Inserts<br>(K040166) | |----------------|-------------------------------------------------------------|--------------------------------------------------------------| | Material | AOX UHMWPE conforming<br>to ASTM F648 | XLK UHMWPE conforming<br>to ASTM F648 | | Sizes | Proportional sizing<br>CR inserts, sizes 1 to 10 | Constant sizing<br>Curved and PLI inserts, sizes<br>1.5 to 6 | | | Actual thicknesses 5, 6, 7, 8,<br>10, 12, 14, 16, and 18mm. | Composite thicknesses 8, 10,<br>12.5, 15, 17.5, and 20mm. | {3}------------------------------------------------ K101433 #4/6 | Characteristic | Attune™ Tibial Base | Sigma Co-Cr<br>Tibial Trays (K032151) | |---------------------|-----------------------------------------------|--------------------------------------------------| | Material | Cast Co-Cr-Mo alloy<br>conforming to ASTM F75 | Forged Co-Cr-Mo alloy<br>conforming to ASTM F799 | | Sizes | Sizes 1 to 10 | Sizes 1.5 to 6 | | Fixation<br>Surface | Cemented | Cemented | | Characteristic | Attune™ Patellae | Sigma 3-Peg Oval Patella<br>(K961685, K950010) | |---------------------|---------------------------------------|-------------------------------------------------| | Material | AOX UHMWPE conforming<br>to ASTM F648 | UHMWPE conforming to<br>ASTM F648 | | Sizes | Sizes 29, 32, 35, 38, 41mm | Size 32 (K961685)<br>Sizes 35, 38, 41 (K950010) | | Fixation<br>Surface | Cemented | Cemented | # Summary of Substantial Equivalence: The DePuy Attune Total Knee System is substantially equivalent to currently marketed devices as demonstrated with preclinical data. ### Non-Clinical Testing: Physical and mechanical testing was conducted on the AOX ultra high molecular weight polyethylene in accordance with ASTM F648. This testing includes the following characterization: - Yield Strength ● - Ultimate Tensile Strength . - Elongation to Break - . Young's Modulus - . Impact Resistance - Fatigue Crack Propagation - ◆ Compression Modulus - Crystallinity (Differential Scanning Calorimetry) . - Peak Melting Temperature (Differential Scanning Calorimetry) . - . Ash Content - Gravimetric Swell Ratio ● - Oxidation Index (Fourier Transform Infrared Spectroscopy) . {4}------------------------------------------------ The biocompatibility test plan developed to evaluate the AOX material was in ্ accordance with the ISO draft Guidance on the Conduct of Biological Evaluation within a Risk Management Process (ISO/DTR 15499). Discussions of Risk Assessment with NAMSA provided additional guidance for establishing the series of biocompatibility tests to evaluate the AOX material. The test plan included methods that address FDA guidance documents and specifically ISO 10993 parts 3-6, 10, and 11. In addition to the ISO 10993 tests, other USP tests to characterize leachable components were conducted. Functional testing was conducted in compliance with FDA guidance, Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA, to verify that the implant performance would be substantially equivalent to predicate devices for anticipated in vivo loading via various constraint and fatigue tests. In vitro knee simulator wear testing provided in the submission demonstrated that the Attune CR femoral component/tibial insert couple exhibited a significant volumetric wear reduction as compared to a control total knee system. The results of in-vitro wear simulation testing have not been proven to quantitatively predict clinical wear performance. Attune CR Fixed Bearing Wear Claim Information: DePuy manufactured both the Attune CR fixed bearing total knee (subject) and the Sigma CR Curved fixed bearing total knee (control) in this wear test. All Attune CR products tested were size 5 while all Sigma CR products tested were size 3. The actual insert thicknesses used were 6mm for the Attune CR tibial AOX polyethylene insert (composite insert and base thickness of 10mm) and actual insert thickness of 8mm for the Sigma Curved tibial XLK polyethylene insert (composite insert and tray thickness of 10mm). The Attune CR inserts were manufactured from antioxidant stabilized compression molded GUR 1020 UHMWPE. The Sigma Curved inserts were manufactured from crosslinked (50 kGy) compression molded GUR 1020 UHMWPE. The Attune CR CoCr femoral and fixed bearing tibial base components were not sterilized for the tests. The Attune CR AOX fixed bearing inserts were sterilized and crosslinked via gamma radiation (75.0 - 90.0 kGy) and packaging (vacuum in foil pouch). The Sigma CR CoCr femoral and fixed bearing tibial tray components were sterilized via gamma radiation (28.5 kGy). The Sigma Curved XLK fixed bearing inserts were sterilized via gas plasma sterilization. Wear testing was performed via AMTI multi-axial displacement controlled knee joint simulator per ISO 14243-3 loads combined with published physiological kinematics at a frequency of 1 Hz for 5 million cycles utilizing a lubricant of 25% bovine serum with an average protein content of 16.5 mg/ml . The Attune mean gravimetric wear rate was 3.6 ± 0.3 {5}------------------------------------------------ K101433 # 6/6 mg/million cycles while the Sigma mean gravimetric wear rate was 7.12 ± 1.2 mg/million cycles. Thus the Attune CR fixed bearing total knee system exhibits 50% less overall mean gravimetric wear than the previously cleared DePuy Sigma Curved fixed bearing total knee system for the same composite thickness. The wear debris was analyzed at 1, 3, and 5 million cycles via LALLS and SEM analysis. The Attune AOX mean particle diameter (LALLS volume analysis), aspect ratio (SEM), roundness (SEM), and perimeter (SEM) measured 118,8um. 2.10, 0.56, and 3.56um while Sigma XLK measured 64.4um, 2.06, 0.56, and 3.17um respectively. No significant difference between the AOX and XLK debris samples was found. Wear testing to 10 million cycles was also performed utilizing the thinnest available insert thicknesses, actual insert thickness of 5mm for the Attune CR tibial AOX polyethylene insert (composite insert and base thickness of 9mm) and actual insert thickness of 6mm for the Sigma Curved tibial XLK polyethylene insert (composite insert and tray thickness of 8mm). The Attune mean gravimetric wear rate for the thin inserts was 5.4 ± 0.5 mg/million cycles while the Sigma mean gravimetric wear rate for the thin insert was 5.7 ± 0.7 mg/million cycles with no statistical difference in wear rate. In vitro knee wear simulator tests have not been shown to quantitatively predict clinical wear performance. #### Clinical Testing: None provided as it was not necessary to determine substantial equivalence between the Attune Knee System and the predicate devices. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 DePuy Orthopaedics, Inc. % Ms. Nancy Friddle 700 Orthopaedic Drive Warsaw, Indiana 46581 DEC 1 0 2010 Re: K101433 Trade/Device Name: DePuy Attune™ Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi- constrained cemented prosthesis Regulatory Class: Class II Product Code: OIY, JWH Dated: December 6, 2010 Received: December 7, 2010 Dear Ms. Friddle: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelore, manel of the Act include requirements for annual registration, listing of general obtarely proficturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulticlation. Trease note: ODICI abos not be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (boo acove). Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease be advised that I DA 3 issuance or or device complies with other requirements of the Act that I DA has made a acterimances as administered by other Federal agencies. You must or any Federal statutes and regulations and instituting, but not limited to: registration and listing (21 comply with an the Fee orequirements of the more reporting (reporting of medical {7}------------------------------------------------ # Page 2 – Ms. Nancy Friddle device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set device-related adverse events) (2) CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you ucare specific advice to: your cornices/CDRH/CDRHOffices/ucm115809.htm for go to millib.row.rou.gov.rt.badiological Health's (CDRH's) Office of Compliances and Radiological Health the comer for Dorroes and Nations. note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulation onlined, "including of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Tou may other of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ DEC 1 0 2010 # 2. INDICATIONS FOR USE 510(k) Number (if known): _KLO1Y 33 Device Name: DePuy Attune™ Knee System Indications for Use: The DePuy Attune™ Knee System is intended for cemented use as a total knee replacement system. Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, theumatoid arthritis, or a failed previous implant. AND/OR Prescription Use _ X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 for U. Melkerson (Division Sign-Off) (Division Surgical, Orthopedic, and Restorative Devices 510(k) Number K101433