UNICONDYLAR INTERPOSITIONAL SPACER
Device Facts
| Record ID | K003269 |
|---|---|
| Device Name | UNICONDYLAR INTERPOSITIONAL SPACER |
| Applicant | Sulzer Orthopedics, Inc. |
| Product Code | HSH · Orthopedic |
| Decision Date | Jan 4, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3590 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This prosthesis is made of alloys, such as cobalt-chromium-molybdenum, and is intended to resurface one tibial condyle. The generic type of device is limited to those prostheses intended for use without bone cement (§ 888.3027).
