FDA product code NJL: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

NJL is the FDA product code for prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing. It is a Class III device, reviewed by the Orthopedic panel. Devices under NJL reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 269 recalls for NJL devices.

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.

Classification

Recalls for NJL devices

269 product recalls in 15 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-08-10.

Frequently asked questions

What is FDA product code NJL?

NJL is the FDA product code for prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing. It is a Class III device, reviewed by the Orthopedic panel.

What device class is NJL?

Class III. Typical premarket route: PMA.

Have NJL devices been recalled?

Yes: 269 product recalls across 15 recall events; the most recent began 2021-08-10.

Next steps

• Run an FDA pathway report with predicate devices for product code NJL
• Run a recall and safety report across every NJL manufacturer
• Watch product code NJL for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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