THE POSTERIOR STABILISED NUFFIELD TOTAL KNEE SYSTEM

{0}------------------------------------------------ DEC 19 1997 | Name of Company: | Corin Medical Ltd | |------------------|---------------------| | | The Corinium Centre | | | Cirencester | | | Gloucestershire | | | GL7 1YJ | | | England | Posterior Stabilised Nuffield Total Knee System Name of Device: The Posterior Stabilised Total Knee Replacement System is a line Device Description: extension of the previously cleared Nuffield Total Knee System which has been on the market since 1989. 510(k) SUMMARY The device is used to restore knee function in patients with degenerative rheumatoid or osteoarthritis in cases where the degenerative process has led to non or inadequate function of the posterior cruciate ligament. The device incorporates cobalt-chrome alloy femoral and tibial components and a UHMWPE tibial insert. Alternatively, an all-polyethylene tibial component may be implanted. ## SUBSTANTIAL EQUIVALENCE AND SAFETY AND SUMMARY OF EFFECTIVENESS The Posterior Stabilised Nuffield Total Knee System is substantially equivalent to both the Insall Burstein II Knee System promoted by Zimmer in the USA since 1987 and the Nuffield Total Knee System promoted by Corin Medical since 1989. The reasons for this are summarised below. - All are three part knees utilising cobalt-chrome alloy femoral and tibial components a) and a UHMWPE tibial insert. - All three have a range of sizes of components and thicknesses of polyethylene inserts. b) - c) All are designed for cemented use only. : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : Company - d) All contain within the range an all-polyethylene monoblock tibial component for low demand patients. This submission is supported by extensive mechanical test data confirming the devices' safety and effectiveness. The Posterior Stabilised Nuffield Total Knee System has been in clinical use outside the United States for eight years and no significant post-operative problems have been reported. {1}------------------------------------------------ Image /page/1/Picture/2 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 a stylized image of an eagle with three profiles, representing the department's mission to protect the health of all Americans and provide essential human services. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ........... DEC 1 9 1997 Mr. Craig Corrance ·President Corin U.S.A. 10500 University Center Drive, Suite 130 Tampa, Florida 33612 K973595 Re: Posterior Stabilised Trade Name: Nuffield Total Knee System Requlatory Class: II Product Code: ਹੈਕਸ September 4, 1997 Dated: Received: September 22, 1997 Dear Mr. Corrance: 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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. {2}------------------------------------------------ ## Page 2 - Mr. Craig Corrance This letter will allow you to begin marketing your device as described in your 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 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 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, lia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ K97 - 3595 510(k) Number (if known): The Posterior Stabilised Nuffield Total Knee System Device Name: ## INDICATIONS FOR USE Relief of pain and restoration of knee function following the effects of osteo, rheumatoid and inflammatory arthritis, post-trauma disease effects, avascular necrosis, and total knee revision with or without varus, valgus or flexion deformity. The tibial and femoral components are intended for use with bone cement. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation colee (Division) Sign-Off) Division of General Restorative Devices K973595 510(k) Number Prescription Use _ X (per 21 CFR 801.109) હતું. તું તે જેન્દ્રનું રહ્યું છે. સુરત પુરસ્ત્ર જીવની સાંતર પ્રદૂધની ડેરી જેવી સાંતર પ્રદાતના પાકની ખેતી કરવામાં આવેલું છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________