ULNAR HEAD IMPLANT
Device Facts
| Record ID | K010786 |
|---|---|
| Device Name | ULNAR HEAD IMPLANT |
| Applicant | Avanta Orthopaedics, Inc. |
| Product Code | KXE · Orthopedic |
| Decision Date | Apr 11, 2001 |
| Decision | SESE |
| Submission Type | Special |
| 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.
