NJL

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: NJL
Classification and pathway per current FDA publications. Data from openFDA (CC0).