FDA product code NXT: Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

NXT is the FDA product code for prosthesis, hip, semi-constrained, metal/metal, resurfacing. It is a Class III device, reviewed by the Orthopedic panel. Devices under NXT reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code. FDA has posted 6 recalls for NXT devices.

Definition

Prosthesis, hip, semi-constrained, metal/metal, resurfacing device relieves hip pain and improves hip function by replacing the parts of the hip that have been severely damaged by degenerative joint diseases. This device is indicated for patients with degenerative joint diseases including osteoarthritis, rheumatoid arthritis, traumatic arthritis, dysplasia, or avascular necrosis and for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip replacement due to an increased possibility of requiring future hip joint revision.

Classification

Recalls for NXT devices

6 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-07-14.

Frequently asked questions

What is FDA product code NXT?

NXT is the FDA product code for prosthesis, hip, semi-constrained, metal/metal, resurfacing. It is a Class III device, reviewed by the Orthopedic panel.

What device class is NXT?

Class III. Typical premarket route: PMA.

Have NXT devices been recalled?

Yes: 6 product recalls across 3 recall events; the most recent began 2021-07-14.

Next steps

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