SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS

{0}------------------------------------------------ P. 1/2 # 510(k) Summary of Safety and Effectiveness | Device: | Scorpio® X3™ UHMWPE Tibial Inserts and Scorpio®<br>X3™ UHMWPE Patellar Components | |--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification: | 21 CFR 888.3560 - Knee joint patellofemorotibial<br>polymer/metal/polymer semi-constrained cemented<br>prosthesis | | | 21 CFR 888.3565 - Knee joint patellofemorotibial<br>metal/polymer porous-coated uncemented prosthesis | | Product Code | 87 JWH, 87 MBH | | Predicate Devices: | Scorpio® Polyethylene Tibial Inserts and Scorpio®<br>Polyethylene Patellar Components | | Contact Person: | Karen Ariemma<br>Senior Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>(201) 831-5718<br>(201) 831-6038 (FAX)<br>karen.ariemma@stryker.com | Date Summary Prepared: September 28, 2005 #### Device Description The device includes tibial and patellar components of a total knee system. These components are used for the replacement of the bearing and/or articulating surfaces of the proximal tibia and patclla. The modification to the device subject of this premarket notification is the sequentially crosslinking and annealing of the UHMWPE material by a proprietary process. Tibial inserts will be made in Cruciate Retaining, Posterior Stabilized and Total Stabilizing designs. Patellar components will be made in Medialized Dome, Concentric Dome, Universal Dome, Recessed and Inset designs #### Indications For Use The Scorpio® X3™ UHMWPE Cruciate Retaining and Posterior Stabilized tibial inserts and the Scorpio® X3TM UHMWPE all polyethylene patellar components are intended to be used with cemented or cementless Scorpio femoral components, cemented or ccmcntless Series 7000 tibial tray components and cemented Scorpio® tibial tray components in primary or revision total knee arthroplasty. The all polyethylene Scorpio 6 X3™ UHMWPE patellar components are intended for implantation with bone cement only. {1}------------------------------------------------ 051977 The Scorpio® X3™ Total Stabilizer tibial inserts are intended to be used with the cemented Scorpio TS femoral components and the cemented Scorpio or Series 7000 tibial trays in primary or revision total knec arthroplasty. The Scorpio® Knee System components are for use in total knee atthroplasty as a result of: - Painful, disabling joint disease of the knee resulting from degencrative athritis, 후 rheumatoid arthritis or post-traumatic arthritis. - Post-traumatic loss of knee joint configuration and function. . - Moderate varus, valgus or flexion deformity in which the ligamentous structures . can be returned to adequate function and stability. - Revision of previous unsuccessful knee replacement or other procedure. ● Additional indications for Posterior Stabilized Components: - Ligamentous instability requiring implant bearing surface geometries with ● increased constraint. - Absent or non-functioning posterior cruciate ligament. . Additional indications for Total Stabilized (TS) Components: - Severe anteroposterior and medial/lateral instability of the knee. . ### Summary of Data Sunning you Data equivalence of the subject products to the predicate devices. Testing and analysis includes material properties characterization, wear testing, disassembly force evaluation, multi-axis fatigue testing, patella shear testing and finite element modeling of contact stresses. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular pattern around the eagle. The logo is black and white. Public Health Service 0CT 1 2 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Karen Ariemma Senior Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430 Re: K051977 Trade/Device Name: Scorpio Knee System-Tibial Inserts and Patellar Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH, MBH Dated: July 19, 2005 Received: July 21, 2005 Dear Ms. Ariemma: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Docker on (c) f referenced above and have determined the device is substantially equivalent (for the indications for referented in the enclosure) to legally marketed predicate devices marketed in interstate commerce uss stated in the energies in the Medical Device Amendments, or to devices that provision in the provisions 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 general thereone, manier the act include requirements for annual registration, listing of devices, good controls pro risions one labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it rr your are rise to such additional controls. 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ ## Page 2- Karen Ariemma This letter will allow you to begin marketing your device as described in your Section 510(k) rms leter watification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html. Sincerely yours, Mark N. Mello Co Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # K051977 510(k) Number (if known): _ Device Name: Scorpio Knec System - Tibial Inserts and Patellar Components Indications for Use: The Scorpio® X3™ UHMWPE Cruciate Retaining and Posterior Stabilized tibial inserts and the Scorpio X3™ UHMWPE all polyethylene patcllar components are intended to be used with Scorpio X3 ™ UHM WFL all polychylono parents, cemented or cementless Senies 7000 tibian total local cemented of cementiess Scopio" ithink tibiable and components in primary or revision total knews are interested arthroplasty. The all polyethylene Scorpio X3M UHMWPE patellar components are intended for implantation with bone cement only. The Scorpio® X3™ Total Stabilizer tibial inserts are intended to be used with the cemented The Scorpio" X31" Total Stannisci dollar inserts are theirder woo cores. Scorpio" TS femoral components and the cemented Scorpio" or Series 7000 tibial trays in primary or revision total knee arthroplasty. The Scorpio " Knee System components are for use in total kncc arthroplasty as a result of: - Painful, disabling joint disease of the knee resulting from degenerative arthritis, . rheumatoid arthritis or post-traumatic arthritis. - Post-traumatic loss of knee joint configuration and function. . - Fost-traumance 1033 or know John version ity in which the ligamentous structures can be . returned to adequate function and stability. - Revision of previous unsuccessful knee replacement or other procedure. . Additional indications for Posterior Stabilized Components: - hial intuceatous for I overlex oring implant bearing surface geometries with increased . constraint - Absent or non-functioning posterior cruciate ligament. . Additional indications for Total Stabilized (TS) Components: - Severe anteroposterior and medial/lateral instability of the knee joint. . Prescription Use X (Per 21 CFR 801.109) OR Over-the-Counter Use (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEBDED) Concurrence of CDRH, Office of Device Evaluation (ODE) 2 Page 1 of l (Division Sign-Off) Division of General, Restorative, and Neumlogical De 510(k) Number K051977