FDA product code NTG: Prosthesis, Ankle, Uncemented, Non-Constrained

NTG is the FDA product code for prosthesis, ankle, uncemented, non-constrained. It is a Class III device, reviewed by the Orthopedic panel. Devices under NTG reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 4 recalls for NTG devices, 2 initiated in the last five years.

Definition

An ankle joint metal/polymer non-constrained uncemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a tibial component made of alloys, such as cobalt-chromium-molybdenum, and a talar component made of ultra-high molecular weight polyethylene.

Classification

Recalls for NTG devices

4 product recalls in 3 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2026-03-24.

Frequently asked questions

What is FDA product code NTG?

NTG is the FDA product code for prosthesis, ankle, uncemented, non-constrained. It is a Class III device, reviewed by the Orthopedic panel.

What device class is NTG?

Class III. Typical premarket route: PMA.

Have NTG devices been recalled?

Yes: 4 product recalls across 3 recall events; the most recent began 2026-03-24.

Next steps

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