SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)
Device Facts
| Record ID | K812053 |
|---|---|
| Device Name | SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) |
| Applicant | Dow Corning Corp. Healthcare Industries Materials |
| Product Code | KXE · Orthopedic |
| Decision Date | Aug 18, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3810 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.
