NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a stylized letter Z inside of a circle on the left, followed by the word "zimmer" in lowercase letters on the right. The logo is black and white. 1/3 | JAN 0 9 2002 | Summary of Safety and Effectiveness | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 | | Contact Person: | Stephen McKelvey<br>Manager, Regulatory Affairs<br>Telephone: (219) 372-4944<br>Fax: (219) 372-4605 | | Date: | October 11, 2001 | | Trade Name: | <i>NexGen</i> ® Complete Knee Solution Rotating Hinge<br>Knee | | Common Name: | Total Knee Prosthesis | | Classification Name<br>and Reference: | Knee joint femorotibial metal/polymer constrained<br>cemented prosthesis, 21 CFR § 888.3510 | | Predicate Device: | Finn Knee System, manufactured by Biomet,<br>K945028, cleared February 14, 1996 | | Device Description: | The <i>NexGen</i> Rotating Hinge Knee (RHK) is a knee<br>prosthesis that is constrained in the anterior/<br>posterior and medial/lateral directions but allows<br>flexion/extension and rotation between the femoral<br>and tibial components. Constraint in the anterior/<br>posterior and medial/lateral directions is<br>accomplished by means of a femoral hinge post<br>extension inserted through the polyethylene<br>articular surface into the tibial baseplate.<br><br>This prosthesis is designed to be used with Zimmer<br><i>NexGen</i> ® Complete Knee Solution patellar<br>components, femoral and tibial augments, and stem<br>extensions. The articular surface is available in<br>multiple thicknesses to facilitate soft tissue<br>tensioning and joint line restoration. Tibial<br>baseplate components are available in multiple sizes<br>to allow for optimal bone coverage and surgical<br>options. | {1}------------------------------------------------ 9.213 This device is indicated for moderate to severe knee Intended Use: instability, significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle, valgus, varus, or flexion deformities and/or for the salvage of previously failed surgical attempts. This device is intended for cemented use only. The RHK device is substantially equivalent to the Comparison to Predicate Device: Finn Knee System in that both have similar indications, design (both are constrained, rotating hinge knee prostheses), materials and mechanical safety. Both devices are intended for cemented use only. Non-Clinical Performance and Conclusions: Performance Data (Nonclinical and/or Clinical): Constraint testing is not applicable to a constrained prosthesis. This test was not necessary. Contact area was greater for the RHK than the Finn for the range 0 - 120°. At 130°, the Finn had greater contact area. The RHK interlock mechanism passed all distraction (lift-off) testing. All RHK test samples completed the 10 million cycle Tibial Baseplate Fatigue Strength testing without evidence of fracture or cracking. No additional lateral stability of the patellofemoral joint data was needed because the RHK uses similar patella femoral tracking as previously cleared NexGen femoral components. No additional shear strength or metal-backed patella static tensile data was needed because the RHK uses previously cleared patella devices. The RHK components passed all combined load fatigue and pin loosening testing. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized "Z" inside, followed by the word "zimmer" in a bold, sans-serif font. The "Z" in the circle is black, and the circle itself is white with a black outline. The word "zimmer" is also black and is positioned to the right of the circle. Minimum polyethylene thickness is greater than 6 mm, therefore, wear testing was not needed for the RHK device. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing to the right, arranged in a way that they appear to be connected or overlapping. The profiles are black against a white background. Encircling the profiles is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 0 9 2002 Mr. Stephen McKelvey Manager, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708 Re: K013385 Trade/Device Name: NexGen Complete Knee Solution Rotating Hinge Knee Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: KRO Dated: October 11, 2001 Received: October 12, 2001 Dear Mr. McKelvey: 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 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 (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. {4}------------------------------------------------ Page 2 - Mr. Stephen McKelvey This letter will allow you to begin marketing your device as described in your Section 510(k) premarket 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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 દિવ Sincerely yours, Signature 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 {5}------------------------------------------------ ## Indications for Use KOS382 Page 1 of 1 510(k) Number (if known): Device Name: NexGen® Complete Knee Solution Rotating Hinge Knee Indications for Use: This device is indicated for moderate to severe knee instability, significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle, valgus, varus, or flexion deformities and/or for the salvage of previously failed surgical attempts This device is intended for cemented use only. (Division Sign-Off) Division of General Restorative and Neurological Devices 510(k) Number K ©1338 S (Please do not write below this line - Continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use _ (Optional Format 1-2-96)