SYNATOMIC VARIABLE FIT TIBIAL PLATEAU
Device Facts
| Record ID | K851341 |
|---|---|
| Device Name | SYNATOMIC VARIABLE FIT TIBIAL PLATEAU |
| Applicant | Depuy, Inc. |
| Product Code | KYK · Orthopedic |
| Decision Date | Jul 15, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3500 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A knee joint femorotibial metal/composite semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component with the articulating surfaces made of ultra-high molecular weight polyethylene with carbon-fibers composite and is limited to those prostheses intended for use with bone cement (§ 888.3027).
