P.F.C. UNICONDYLAR KNEE SYSTEM
Device Facts
| Record ID | K910968 |
|---|---|
| Device Name | P.F.C. UNICONDYLAR KNEE SYSTEM |
| Applicant | Johnson & Johnson Orthopaedics, Inc. |
| Product Code | HRY · Orthopedic |
| Decision Date | Aug 26, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3530 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).
