FDA product code NRA: Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

NRA is the FDA product code for prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing. It is a Class III device, reviewed by the Orthopedic panel. Devices under NRA reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 32 recalls for NRA devices.

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.

Classification

Recalls for NRA devices

32 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-01-05.

Frequently asked questions

What is FDA product code NRA?

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

What device class is NRA?

Class III. Typical premarket route: PMA.

Have NRA devices been recalled?

Yes: 32 product recalls across 4 recall events; the most recent began 2016-01-05.

Next steps

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