NATURAL-KNEE TIBIAL AND FEMORAL SPACERS
Device Facts
| Record ID | K915240 |
|---|---|
| Device Name | NATURAL-KNEE TIBIAL AND FEMORAL SPACERS |
| Applicant | Intermedics Orthopedics |
| Product Code | HSX · Orthopedic |
| Decision Date | Jan 31, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3520 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A knee joint femorotibial metal/polymer non-constrained cemented 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 generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).
