NJL
- Product code
- NJL
- Device name
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
- Device class
- Class 3
- Medical specialty
- Unknown
- Marketing pathway
- PMA
- Flag
- Implant
FDA classification 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.
Official FDA classification page: NJL
Classification and pathway per current FDA publications. Data from openFDA (CC0).