SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING

{0}------------------------------------------------ Scorpio" Total Knee System w/ Peri-Apatite® Couting K033971 Page 1 of 2 510(k) Premarket Notification ## MAY 2 8 2004 ## Summary of Safety and Effectiveness | Contact Person: | Denise Duchene<br>Sr. Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Dr.<br>Mahwah, NJ 07430<br>(201) 831-5612 (Phone)<br>(201) 831-6038 (FAX) | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date: | December 10, 2003 | | Device: | Scorpio® Total Knee System | | Classification: | Knee Joint; Patellofemorotibial; Metal/polymer; Porous-coated;<br>Uncemented prosthesis - Class II - 21 CFR 888.3565 | | Predicate Devices: | Scorpio® Total Knee System | | Indications for Use: | The Scorpio® Total Knee System components are for use in total<br>knee arthroplasty to relieve pain and restore knee function for<br>indications such as: painful, disabling joint disease of the knee<br>resulting from degenerative arthritis, rheumatoid arthritis or post-<br>traumatic arthritis; post-traumatic loss of knee joint configuration<br>and function; moderate varus, valgus or flexion deformity in which<br>the ligamentous structures can be returned to adequate function<br>and stability; revision of previous unsuccessful knee replacement<br>or other procedure. Additional indications for the posterior<br>stabilized components include: ligamentous instability requiring<br>implant bearing surface geometries with increased constraint;<br>absent or non-functioning posterior cruciate ligament.<br>These products are intended to achieve fixation without the use of<br>bone cement | | Proposed Modification: | To add a Peri-Apatite® coating and allow for use without bone<br>cement. | | Device Description: | The device includes femoral and tibial components of a total knee<br>system. These components are used for the replacement of the<br>bearing and/or articulating surfaces of the distal femur, proximal<br>tibia to relieve pain, instability and the restriction of motion due to<br>degenerative bone disease, including osteoarthritis, rheumatoid | | | arthritis, failure of other devices or trauma. | {1}------------------------------------------------ ## Summary of Data: A risk analysis and research and development testing have been performed to demonstrate equivalence of the proposed products to the predicate devices. The testing includes porous coating characterization, baseplate fatigue testing, contact area / stress analyses; range of motion range of constraint testing; locking mechanism testing; UHMWPe material properties in accordance with the Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA," dated January 16, 2003. The testing also includes safety testing for the Peri-Apatite® coating and a summary of the effect of the coating on pore size and pore volume. The results demonstrate that the Scorpio Total Knee System with Peri-Apatite® coating is safe and effective for total knee replacement without bone cement. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized stripes or lines, possibly representing the concept of health or human services. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 2 8 2004 Ms. Lorraine T. Montemurro Manager, Regulatory Affairs Stryker Howmedica Osteonics 325 Corporate Drive Mahwah, New Jersey 07430 Re: K033971 Trade/Device Name: Scorpio Total Knee System with Peri-Apatite® Coating Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint, patcllofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: II Product Code: MBH Dated: April 20, 2004 Received: April 21, 2004 Dear Ms. Montemurro: We have reviewed your Scction 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 may be subject 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 comply 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 (OS) 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 - Ms. Lorraine T. Montemurro This letter will allow you to begin marketing your device as described in your Section 510(k) rms istet notification. 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 in you t the Office of Compliance at (301) 594-4659. 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/cdrh/dsma/dsmamain.html Sincerely vours, Sincerely yours, L. Mark A. Mulkerson Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page | 510(k) Number (if known): | K033971 | |---------------------------|---------| |---------------------------|---------| Device Name: Scorpio" Total Knec System with Peri-Apatite® Coating Indications for Use: The Scorpio® Total Knee System components included in this submission are intended for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as: - Painful, disabling joint discase of the knee resulting from degenerative arthritis, . 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 the posterior stabilized components include: - Ligamentous instability requiring implant bearing surface geometrics with increased . constraint - Absent or non-functioning posterior cruciate ligament These components are single use only and are intended for implantation without bone cement. (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Deuce Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices | <strong>Labels</strong> | <strong>Values</strong> | |-------------------------|-------------------------| | Prescription Use | X | | 510(k) Number | K033971 | | Over-the-Counter Use | | (Per 21 CFR 801.109) OR