Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
The Patellofemorotibial Semi-Constrained Mobile Bearing Knee Prosthesis (Metal/Polymer) is a total knee replacement implant designed to allow motion between the plastic bearing and metal baseplate components, intended to replace a knee joint to relieve pain and restore function for conditions including osteoarthritis, inflammatory arthritis, traumatic arthritis, and revision of failed knee prostheses. It is classified as FDA Class 3 (Premarket Approval), requiring PMA approval, under product code NJL in the Orthopedic review panel (no regulation number assigned). The device is flagged as an implant but is not life-sustaining.
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Basic Information
- Product Code
- NJL
- 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 bearing and metal baseplate components of a knee prosthesis. It is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis, inflammatory arthritis, traumatic arthritis, and revision of failed knee prostheses.
FEI Numbers
This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.