26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for StelKast company. The logo features a stylized letter "S" above the company name. The word "StelKast" is in a bold, italicized font, with a horizontal line running through the middle of the word. Below "StelKast" is the word "company" in a smaller, non-italicized font. May 4, 1999 ## 26 MM CAST CoCr HEAD AND POLYETHYLENE ACETABULAR SHELL LINER ## Summary of Safety and Effectiveness Information Upon Which The Substantial Equivalence Determination is Based [510(k) Summarv] The 26 mm CoCr Head and Hooded Liner are manufactured from biocompatible materials: Co-Cr-Mo alloy and ultra-high molecular-weight polyethylene (UHMWPE). These materials are in current use in numerous hip systems and their use has been established through many years of successful clinical application. Fatigue testing of the stem and 26 mm head was satisfied under previously released 510(k) submissions. Likewise, the liner testing was satisfied under previous 510(k) submissions since only the I.D. has been changed. A smaller CoCr head with appropriate liner was manufactured to increase polyethylene minimal thickness in the smaller diameter acetabular cups. These components will supplement 28 mm CoCr heads and liners already released in the ProForm and Provident Hip Systems. ▲ Phone: (412) 322-8280 ◀ {1}------------------------------------------------ Image /page/1/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 resembling an eagle or bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 14 1999 Mr. Donald A. Stevens President StelKast Company 800 Vinial St., Suite B-210 Pittsburgh, Pennsylvania 15212 Re: K991622 Trade Name: 26 mm CoCr Head and Polyethylene Liner Regulatory Class: II Product Code: JDI/LPH Dated: May 4, 1999 Received: May 11, 1999 Dear Mr. Stevens: 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 control provisions of the Act. The general control 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 (Premarket Approval), 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 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 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 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. {2}------------------------------------------------ Page 2 -- Mr. Donald A. Stevens 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 at (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 {3}------------------------------------------------ 510(K) Number (if known): 26 mm Cast CoCr Head and Polyethylene Acetabular Shell Liner Device Name: Indications For Use: 1. Joint impairment from arthritis (rheumatoid, osteo and post traumatic). 2. Revision of failed femoral head replacements. 3. When alternative reconstructive techniques are not viable. - 4. When arthrodesis is contraindicated. - 5. Avascular necrosis or fracture of the femoral head. - 6. Congenital defects that will allow adequate function of the system. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) OR \$\infty\$ neral Restorative Devices **Prescription Use** **(Per 21 CFR 801.109)** Over-The-Counter Use se HB (Optional Format 1-2-96)