JWI · Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained
Orthopedic · 21 CFR 888.3800 · Class 2
Overview
| Product Code | JWI |
|---|---|
| Device Name | Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, 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 (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K931265 | FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND | Ferguson Medical | May 22, 1995 | SN |
| K940297 | UNIVERSAL WRIST | Turnkey Intergration USA, Inc. | Feb 6, 1995 | SN |
| K792687 | ASPERGILLUS SP., ANTIGEN | Meridian Diagnostics, Inc. | Jan 17, 1980 | SESE |
Top Applicants
- Turnkey Intergration USA, Inc. — 1 clearance
- Meridian Diagnostics, Inc. — 1 clearance
- Ferguson Medical — 1 clearance
