Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
The Unicompartmental Semi-Constrained Mobile Bearing Femorotibial Knee Prosthesis is a surgical implant designed to replace part of the knee joint in order to relieve pain and restore function in conditions such as osteoarthritis and avascular necrosis. The mobile bearing design allows motion between the plastic tibial bearing and the metal tibial baseplate, which distinguishes it from fixed-bearing unicompartmental knee systems. As an FDA Class 3 device, it requires Premarket Approval (PMA) from the FDA, reflecting the highest level of regulatory scrutiny for devices posing significant patient risk. The product code is NRA, reviewed by the Orthopedic panel, and this device is flagged as an implant.
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Basic Information
- Product Code
- NRA
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- OR
- Submission Type
- 2
Device Characteristics
Definition
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.
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.