V40 ZIRCONIA FEMORAL HEADS

{0}------------------------------------------------ 197236 510(k) Summary Proprietary Name: V40 Zirconia Femoral Heads Common Name: Ceramic Femoral Head Classification Name and Reference: 21 CFR 888.3353 This device is a component of a hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis. Proposed Requlatory Class: Class II Device Product Code: OR(87) LZO For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 (201) 507-6870 Fax: Date Summary Prepared: 6/24/97 This device is a modular femoral head component which is affixed to a femoral stem component and articulates with a polvethylene acetabular cup or a metal backed polvethylene acetabular cup to reconstruct painful and/or severely disabled hip ioints resulting from osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, avascular necrosis, subcapital fracture or a revision of a failed femoral prosthesis. The Zirconia Femoral Heads described in this submission are a modification of a previously cleared Zirconia head (K952418). The modification is a change in the supplier of the device and the introduction of additional sizes. The substantial equivalence is based on an equivalence in intended use, materials, design, operational principles, and relative indications and contraindications to several devices currently in commercial distribution including: Howmedica® V40 Zirconia Femoral Head (K952418) and Howmedica® 32mm Zirconia Femoral Head (2° 52') (K920577). All of the named devices are intended to be used as the modular femoral head component of a total hip replacement. The basic design of these devices is generally the same, with varving diameters and lengths of internal tapers to accommodate individual patient needs. The material used in the manufacture of these heads is also the same. {1}------------------------------------------------ Assembly of all the named femoral head components to an appropriate femoral stem component requires similar instrumentation and preparation. All of the named V40 Zirconia heads are intended to articulate with the femoral components of the previously released Partnership Total Hip System. Relative indications and contraindications for all of the zirconia heads named are the same. Testing of the V40 Zirconia Femoral Heads included ultimate compression strength and axial distraction. All heads tested for ultimate compression strength failed at loads higher than 46 kN as specified in the FDA Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract design of three human profiles facing to the right, with three curved lines above them. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 2 3 1997 Mr. Frank Maas Manager, Regulatory Affairs Howmedica, Inc. Pfizer Hospital Products Group 359 Veterans Boulevard 07070-2584 Rutherford, New Jersey Re: K972361 V40 Zirconia Femoral Heads Regulatory Class: II Product Code: LZO Dated: June 24, 1997 Received: June 25, 1997 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 and the following limitation that the package insert must reflect that the V40 Zirconia Ceramic Femoral Heads are to be used only with Howmedica® Partnership Hip System with 5° 40' taper trunnions. 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 Regulations, Title 21, Parts 800 to 895. ਉ 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 {3}------------------------------------------------ Page 2 - Mr. Frank Maas comply with the GMP requlation 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 Requlations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 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, Celĩa M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K9 7 2 3 C I Device Name: V40 Zirconia Femoral Heads Indications for Use: The V40 Zirconia Femoral Heads are intended to be used with modular femoral components in primary and secondary cementless total hip replacement procedures. These devices are intended to articulate with a polyethylene cup or a metal backed polyethylene cup component to reconstruct painful and/or severely disabled hip joints resulting from osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, avascular necrosis, subcapital fracture, or a revision of a failed femoral prosthesis. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | Complete of the control control and the proportunities and concerners and annual provinces and annual proposes and annon- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | | |---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | Concurrence of CDRH, Office of Device Evalyation (QOB) (O | | | | valuation (ODE) (Division Sign-Off) Division of General Restorative Devices 510(k) Number K972361 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) (