KYK · Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite
Orthopedic · 21 CFR 888.3500 · Class 2
Overview
| Product Code | KYK |
|---|---|
| Device Name | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite |
| Regulation | 21 CFR 888.3500 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
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).
Classification Rationale
Class II.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K880826 | MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM | Johnson & Johnson Professionals, Inc. | Mar 14, 1988 | SESE |
| K871118 | MODIFIED TOWNLEY UNICONDYLAR KNEE | Depuy, Inc. | Apr 6, 1987 | SN |
| K851341 | SYNATOMIC VARIABLE FIT TIBIAL PLATEAU | Depuy, Inc. | Jul 15, 1985 | SESE |
Top Applicants
- Depuy, Inc. — 2 clearances
- Johnson & Johnson Professionals, Inc. — 1 clearance
