NEXGEN COMPLETE KNEE SOLUTION CONVEX INSET PATELLA COMPONENT

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a logo with the letter 'Z' inside a circle above the word 'zimmer'. The 'Z' is bold and black, contrasting with the white background of the circle. The word 'zimmer' is written in a lowercase, sans-serif font, also in black. The overall design is simple and modern. K97-2270 P.O. Box 708 Warsaw, IN 46581-0708 219-267-6131 Summary of Safety and Effectiveness Convex Inset Patella NOV 2 4 1997 - Submitted By: . Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708 219-267-6131 - Contact Person: . Ruth Ann Wood Senior Regulatory Affairs Associate Telephone: 219-372-4944 Fax: 219-372-4605 - Date: . November 4, 1997 - Trade Name: ● NexGen® Complete Knee Solution, Convex Inset Patella - Common Name: . - . Classification Name: Class II 21 CFR 888.3530 - Predicate Devices: . Johnson & Johnson Universal Inset Patella, Insall/Burstein® Patellar Dome Image /page/0/Picture/20 description: The image shows a black and white geometric design labeled with the letter A. The design is a hexagon composed of smaller triangles. Each triangle is further divided into smaller triangles, creating a complex, tessellated pattern within the hexagon. ¹Trademark of the Hospital for Special Surgery {1}------------------------------------------------ - . Device Description The NexGen Convex Inset Patella is made of ultra-high molecular-weight polyethylene (UHMWPE). This patellar component is axisymmetrical. The fixation side geometry is convex in shape. It tapers toward a single post that is coincident with the symmetry axis. - . Intended Use Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. These devices may also be indicated in the salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. Intended for cemented use only. - . Performance Data Shear Testing and Pull-Out Testing - . Clinical Data Studies in the literature demonstrate that satisfactory results are obtained through the use of cemented patellar components. Relevant articles are provided in the 510(k). RA02701K.510 {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Ruth Ann Wood Senior Regulatory Affairs Associate Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708 NOV 2 4 1997 K972270 Re: NexGen® Complete Knee Solution, Convex Inset Patella Requlatory Class: II Product Code: JWH September 30, 1997 Dated: Received: October 2, 1997 Dear Ms. Wood: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone You may, therefore, market your device subject to cement . " the general controls provisions of the Act and the following limitations: - 1. This device may not be labeled or promoted for noncemented use. - 2. All labeling for this device, including package label and labeling included within the package, must prominently state that the device is intended for cemented use only. - 3. Any non-cemented fixation of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for noncemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation. {3}------------------------------------------------ Page 2 - Ms. Ruth Ann Wood The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations. This letter will allow you to beqin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be {4}------------------------------------------------ ## Page 3 - Ms. Ruth Ann Wood obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ 510(k) Number (if known): 长9722270 Device Name: NexGen® Complete Knee Solution, Convex Inset Patella Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, post traumatic loss of joint configuration, particularly when there is patellafemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus or flexion deformities. These devices may also be indicated in the salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. Intended for cemented use only. ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use X (Per 21 CFR 801.109) OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ RA02701K.510 to (Optional Format 1-2-96) (Division Sign-Off) Division of General Restorative Devices 510(k) Number K972270