MJS POSTERIOR STABILIZED KNEE SYSTEM

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is an abstract image of an eagle. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Sam Son Vice President, Technical Affairs Osteoimplant Technology Inc. 11201 Pepper Road Hunt Valley, Maryland 21031 DEC 1 1 2001 Re: K012762 . Trade/Device Name: MJS™ Posterior Stabilized Knee System Regulation Number: 21 CFR §888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HRY Dated: August 14, 2001 Received: August 17, 2001 Dear Mr. Son: We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becated on the device is substantially equivalent (for the indications for referenced above and nave acterially marketed predicate devices marketed in interstate commerce use stated in the energiant date of the Medical Device Amendments, or to devices that provision with the provisions with the provisions of the Federal Food, Drug, and Cosmetic have been roomsonical and 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 therefore, manier the act include requirements for annual registration, listing of devices, good controls provisions and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your de rice to such additional controls. Existing major regulations affecting your device can be may be subject to sam adam 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 r that FDA has made a determination that your device complies with other requirements of the Act or that I Dri has made a doceministered 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. {1}------------------------------------------------ Page 2 - Mr. Sam Son 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 premies in a classification for your device and thus, permits 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 Sincerely yours, Mark N. Millerson 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 {2}------------------------------------------------ Page 1 of 1 Kola762 510(k) Number (if known): 510(k) Device Name: MJS Posterior Stabilized Knee System - Line extension ## Indications For Use: The MJS Posterior Stabilized Knee System is indicated for use in total knee replacement procedures for patients suffering from: - Rheumatoid arthritis. ● - Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose . age, weight, and activity level are compatible with an adequate long-term result. - Failed osteotomies, unicompartmental replacement, or total knee replacement. . The Posterior stabilized system is intended for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact and extra joint stability is required. | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | |----------------------------------------------------------------------------| |----------------------------------------------------------------------------| Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General Restorative Devices 510(k) Number Prescription Use (Per 21 CFR 801.109) X Mark N Millerson Over-The-Counter Use (Optional Format 1-2-96) Division Sign. O 1. Restorative 510(k) Numb K012762