FDA product code NOX: Filler, Bone Void, Synthetic Peptide

NOX is the FDA product code for filler, bone void, synthetic peptide. It is a Class III device, reviewed by the Orthopedic panel. Devices under NOX reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code. FDA has posted 4 recalls for NOX devices, 2 initiated in the last five years.

Definition

The device acts as a bone void filler and consists of a filling material and a synthetic peptide. It is intended to fill traumatic or surgically-created defects that are not intrinsic to the bony structure of the extremities, spine or pelvis. It will be packed or placed into the defect and will resorb over time to be replaced by bone.

Classification

Recalls for NOX devices

4 product recalls in 4 recall events; 2 initiated in the last five years and 1 still open. Most recent: 2025-12-29.

Frequently asked questions

What is FDA product code NOX?

NOX is the FDA product code for filler, bone void, synthetic peptide. It is a Class III device, reviewed by the Orthopedic panel.

What device class is NOX?

Class III. Typical premarket route: PMA.

Have NOX devices been recalled?

Yes: 4 product recalls across 4 recall events; the most recent began 2025-12-29.

Next steps

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