OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM
Device Facts
| Record ID | K862837 |
|---|---|
| Device Name | OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM |
| Applicant | Osteonics Corp. |
| Product Code | HSX · Orthopedic |
| Decision Date | Dec 22, 1986 |
| Decision | SN |
| 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).
