B2C, ESPACE REVISION CUP SYSTEM

{0}------------------------------------------------ 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an abstract caduceus symbol, which is often associated with healthcare and medicine. The caduceus is depicted with a staff and intertwined snakes. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 3 0 1999 Mr. Douglas W. Stuart Surgical Implants, Inc. 962 South Tamiami Trail Suite 203 Sarasota, Florida 34326 K990523 Re: B2C, "Espace" Revision Cup System Trade Name: Regulatory Class: II Product Codes: LPH and JDI February 12, 1999 Dated: Received: February 19, 1999 Dear Mr. Stuart: 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, qood 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. 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. {1}------------------------------------------------ ## Page 2 - Mr. Douglas W. Stuart 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 che regulation chercred) hrobididing by 2018.000 eral 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.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## EXHIBIT 6 ## A Statement of intended Use 510(K) Number Device Name: B2C Revision C ## Statement of Intended Use Indications For Use: The Groupe Lepine B2C Espace, revision acetabular cup system is intended to be used as the pelvic component of a total hip arthoplasty. The acetabular component geometry has been designed to fill large acetabular defects in the floor and superior aspects of the acetabular cavity. It can be implanted either as a press fit cup with bone screw fixation or cemented into the cavity. **Signed:** Dwstiant (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 K990523 510(k) Number | Labels | Values | |-----------------------------------------------|--------| | Prescription Use (Per 21 CFR 801.109) | Yes | | Over The Counter Use (Optional Format 1-2-96) | No |