PARTNERSHIP CALCAR FEMORAL COMPONENTS

{0}------------------------------------------------ APR 1 6 1998 Image /page/0/Picture/1 description: The image shows the text "K9800239" on the top line and "510(k) Summary" on the second line. The top line appears to be handwritten, while the second line is typed. The text is black and the background is white. Proprietary Name: Partnership Calcar Femoral Components Common Name: Hip Prosthesis 21 CFR 888.3353 Classification Name and Reference: Hip Joint Metal/Ceramic/Polymer semi-constrained cemented or nonporous uncemented prosthesis. Proposed Regulatory Class: Class II Device Product Code: LZO Frank Maas For information contact: Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 (201) 507-6870 Fax: Date Summary Prepared: 1-22-98 The Partnership Calcar Femoral Components consist of a family of Titanium femoral stems with Titanium plasma spray coating. The stems are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components in primary and revision total hip arthroplasty. These femoral stems are designed to be press fit into the proximal femur. They do not achieve fixation by biological ingrowth. These femoral components are manufactured from Titanium alloy, Ti-6Al-4V, which meets the requirements of ASTM specification F 136. The Titanium plasma spray coating is CP titanium, which conforms to ASTM specification F 1580. The substantial equivalence of the Partnership Calcar Femoral stems is based on an equivalence in intended use, materials, design, and relative indications and contraindications to Howmedica's Partnership Revision Femoral Components (K972893). Biomet's Mallory-Head Revision System (K945115) and Osteonics' Restoration Monolithic Calcar Replacement Hip Stems (K951932). Testing has demonstrated that the fatigue load carrying capacity of the Partnership Calcar Femoral stems exceeds the minimum ISO load requirements. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract design of a stylized eagle or bird-like figure with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 16 1998 Mr. Frank Maas Manager, Requlatory Affairs Howmedica, Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584 Re: K980239 Partnership Calcar Femoral Components Trade Name: Requlatory Class: II Product Code: LZO and LPH Dated: January 22, 1998 Received: January 23, 1998 Dear Mr. Maas: 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 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 (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. ਜੋ 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 Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlations. {2}------------------------------------------------ ## Page 2 - Mr. Frank Maas 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, for 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}------------------------------------------------ Indications for Use 510(k) Number (if known): k980239 Device Name: Partnership Calcar Femoral Components Indications for Use: The Partnership Calcar Femoral Components consist of a series of Titanium femoral stems with Titanium plasma spray coating that are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components in primary and revision total hip arthroplasty. These femoral stems are designed to be press fit into the proximal femur. They do not achieve fixation by biological ingrowth. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use X OR (Per 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96) Stepten Rhode (Division Sign-Off) Division of General Restorative Devices 5980239 510(k) Number _