KERBOULL CROSS

{0}------------------------------------------------ ## 510(k) Summary Proprietary Name: Kerboull Cross Common Name: Acetabular Reinforcement Shell Classification Name and Reference: Prosthesis, Hip, Acetabular Mesh 21 CFR 878.3300 NOV - 3 1997 Proposed Regulatory Class: Class II Device Product Code: OR(79) JDJ 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: 8-8-97 The Kerboull Cross is intended to be used to reconstruct the acetabulum in primary and/or revision total hip arthroplasty. Specifically, this device is used to reinforce the medial wall of the acetabulum to achieve stable fixation of the acetabular component in the presence of a deficient or weakened medial wall caused by severe inflammatory disease, fracture of the medial wall, or failed total hip arthroplasty. This device will be manufactured in three materials; Stainless Steel, Vitallium, and Titanium alloy. The Kerboull Cross is a hemi-spherical, metal shell that incorporates several flanges and screw holes and is shaped to fit into the acetabulum. These devices are available in a range a outer diameters to fit varying anatomical requirements. The substantial equivalence of the Kerboull Cross is based on an equivalence in intended use, materials, design, and relative indications and contraindications to Depuy's Protrusio Cage (K962007). {1}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV - 3 1997 Mr. Frank Maas Manager, Regulatory Affairs Howmedica Incorporated Pfizer Medical Technology Group 359 Veterans Boulevard 07070-2584 Rutherford, New Jersey Re: K972928 Kerboulli Cross Acetabular Reinforcement Shell Requlatory Class: İI Product Code: JDI Dated: August 8, 1997 Received: August 8, 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 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 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 regulations. {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 requlation (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, Celia M. Witten, Ph.D., M Ph.D., M.D. Cella M. Witten, 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): K972928 Device Name: Kerboull Cross Indications for Use: The Kerboull Cross is intended to be used to reconstruct the acetabulum in primary and/or revision total hip arthroplasty. Specifically, this device is used to reinforce the medial wall of the acetabulum to achieve stable fixation of the acetabular component in the presence of a deficient or weakened medial wall caused by severe inflammatory disease, fracture of the medial wail, or failed total hip arthroplasty. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use (Per 21 CFR 801.109) | X | |---------------------------------------|----------------------| | OR | Over-The-Counter Use | (Division Sign-Off) (Optional Format 1-2-96) Division of General Restorative Devices | 510(k) Number | K972928 | |---------------|---------| |---------------|---------| . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .