KWG · Prosthesis, Finger, Constrained, Metal/Polymer
Orthopedic · 21 CFR 888.3220 · Class 3
Overview
| Product Code | KWG |
|---|---|
| Device Name | Prosthesis, Finger, Constrained, Metal/Polymer |
| Regulation | 21 CFR 888.3220 |
| Device Class | Class 3 |
| Review Panel | Orthopedic |
| Implant | Yes |
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).
Classification Rationale
Class III.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P960053 | BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS | Stryker Corporation | Jun 19, 1997 | APPR |
Top Applicants
- Stryker Corporation — 1 clearance
