KWE · Prosthesis, Finger, Constrained, Metal, Uncemented
Orthopedic · 21 CFR 888.3200 · Class 3
Overview
| Product Code | KWE |
|---|---|
| Device Name | Prosthesis, Finger, Constrained, Metal, Uncemented |
| Regulation | 21 CFR 888.3200 |
| Device Class | Class 3 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A finger joint metal/metal constrained uncemented 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 made of alloys, such as cobalt-chromium-molybdenum, or protheses made from alloys and ultra-high molecular weight polyethylene. This generic type of device is limited to prostheses intended for use without bone cement (§ 888.3027).
Classification Rationale
Class III.
Cleared Devices (0)
No cleared devices on record.
