NRA · Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
· Class 3
Overview
| Product Code | NRA |
|---|---|
| Device Name | Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
Identification
This type of device is designed to allow for motion between the plastic tibial bearing and metal tibial baseplate components of a unicompartmental knee prosthesis. It is intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis and avascular necrosis.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P010014 | OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM | Biomet Manufacturing Corp | Apr 21, 2004 | APPR |
| P910016 | NEW JERSEY LCS(R) TOTAL KNEE SYSTEM | Depuy, Inc. | Oct 30, 1992 | APWD |
Top Applicants
- Biomet Manufacturing Corp — 1 clearance
- Depuy, Inc. — 1 clearance
