KWM · Prosthesis, Wrist, Semi-Constrained
Orthopedic · 21 CFR 888.3800 · Class 2
Overview
| Product Code | KWM |
|---|---|
| Device Name | Prosthesis, Wrist, Semi-Constrained |
| Regulation | 21 CFR 888.3800 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have either a one-part radial component made of alloys, such as cobalt-chromium-molybdenum, with an ultra-high molecular weight polyethylene bearing surface, or a two-part radial component made of alloys and an ultra-high molecular weight polyethylene ball that is mounted on the radial component with a trunnion bearing. The metallic portion of the two-part radial component is inserted into the radius. These devices have a metacarpal component(s) made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).
Classification Rationale
Class II.
Cleared Devices (6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K880156 | VOLZ TOTAL WRIST PROSTHESIS | Biomet, Inc. | Feb 17, 1988 | SESE |
| K872502 | M.W.P. WRIST PROSTHESIS | Protek, Inc. | Jul 23, 1987 | SESE |
| K803031 | LAURE WRIST IMPLANT | Laure Prosthetics, Inc. | Jun 29, 1982 | SESE |
| K800602 | TALEISNIK TOTAL WRIST PROSTHESIS | Dow Corning Wright | Aug 27, 1980 | SESE |
| K801157 | WEBER-MAYO WRIST | Depuy, Inc. | Aug 4, 1980 | SESE |
| K790774 | LODA WRIST PROSTHESIS | Depuy, Inc. | Aug 3, 1979 | SESE |
Top Applicants
- Depuy, Inc. — 2 clearances
- Protek, Inc. — 1 clearance
- Laure Prosthetics, Inc. — 1 clearance
- Dow Corning Wright — 1 clearance
- Biomet, Inc. — 1 clearance
