TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS
Device Facts
| Record ID | K002740 |
|---|---|
| Device Name | TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS |
| Applicant | Smith & Nephew, Inc. |
| Product Code | JWH · Orthopedic |
| Decision Date | Nov 30, 2000 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 888.3560 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace 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 or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).
