BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS
Device Facts
| Record ID | P960053 |
|---|---|
| Device Name | BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS |
| Applicant | Stryker Corporation |
| Product Code | KWG · Orthopedic |
| Decision Date | Jun 19, 1997 |
| Decision | APPR |
| Regulation | 21 CFR 888.3220 |
| Device Class | Class 3 |
Regulatory Classification
Identification
A finger joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. The device prevents dislocation in more than one anatomic plane, and consists of two components which are linked together. This generic type of device includes prostheses that are made of alloys, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).
