PROFIX CONFORMING PLUS TIBIAL INSERT
Device Facts
| Record ID | K946236 |
|---|---|
| Device Name | PROFIX CONFORMING PLUS TIBIAL INSERT |
| Applicant | Smith & Nephew Richards, Inc. |
| Product Code | KWH · Orthopedic |
| Decision Date | Jul 6, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3720 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.
