RADIAL HEAD PROSTHESIS

{0}------------------------------------------------ ## 510(k) Summary Radial Head Prosthesis K 92220 | Submitter's name: | Smith & Nephew, Inc., Orthopaedic Division | |-------------------------------------|---------------------------------------------------------------------| | Submitter's address: | 1450 Brooks Road, Memphis, TN 38116 | | Submitter's telephone number: | 901/399-5153 | | Contact person: | Janet Johnson Green | | Date summary prepared (amended): | February 1, 2000 | | Trade or proprietary device name: | Radial Head Prosthesis | | Common or usual name: | Radial Head Implant | | Classification name: | Title 21 CFR 888.3170<br>Elbow joint radial (hemi-elbow) prosthesis | | Device Class: | Class II | | Device Product Code and Panel Code: | 87KWI | Panel: Orthopaedics/87 # Substantially Equivalent, Legally Marketed Predicate Devices: | Avanta Orthopaedics Radial Head Implant | Avanta Orthopaedics | (K982288) | |-----------------------------------------|---------------------------|-----------| | Swanson Titanium Radial Head Implant | Wright Medical Technology | (K944507) | | Implex Radial Head Replacement System | Implex Corporation | (K984290) | #### Subject device description: The Radial Head Prosthesis, like the predicate devices, includes various sizes of implants to accommodate the requirements of patient anatomy. #### Subject device intended use: The Radial Head Prosthesis is intended for replacement of the proximal end of the radius due to: - degenerative or post-traumatic disabilities presenting pain, crepitation and decreased ● motion at the radiohumeral and/or proximal radio-ulnar joint with: - joint destruction or subluxation visible on x-ray ● - . resistance to conservative treatment - . primary replacement after fracture of the radial head - symptomatic sequelae after radial head resection ● The Radial Head Prosthesis is for single use only. ## Technolocgical Characteristics: The Radial Head Prosthesis is similar to legally marketed devices listed above in that all of these devices are indicated for radial head replacement and are similar in technological characteristics. The Radial Head Prosthesis is manufactured from Cobalt-Chrome, ASTM F 90, ISO 5832-5. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. Public Health Service FEB 2 5 2000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Janet Johnson Green Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc. 1450 Brooks Road Memphis, Tennessee 38116 Re: K992220 Trade Name: Radial Head Prosthesis Regulatory Class: II Product Code: KWI Dated: February 7, 2000 Received: February 10, 2000 Dear Ms. Green: 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 - Ms. Janet Johnson Green 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, Russell Sage رمه James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ 510(k) Number (if known): Device Name: Radial Head Prosthesis Indications for Use: The Radial Head Prosthesis is intended for replacement of the proximal end of the radius due to degenerative or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and/or proximal radio-ulnar joint involving joint destruction or subluxation visible on xray, resistance to conservative treatment; primary replacement after fracture of the radial head; and symptomatic sequelae after radial head resection. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE AS NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Xavier Jugan (Division Sign-Off) Division of General Re 510(k) Number Prescription Use X (Per 21 CFR 601.109) OR Over-The-Counter Use