Identity
- Trade Name
- AUGMENT BONE GRAFT FDA PMA
- Generic Name
- Filler, bone void, synthetic peptide FDA PMA
Identifiers
- PMA Number
- P100006 FDA PMA
- FDA Product Code
- NOX FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Orthopedic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
Augment Bone Graft is a synthetic peptide bone void filler. It is indicated for use as an alternative to autograft in arthrodesis (surgical fusion procedures) of the ankle (tibiotalar joint) and/or hindfoot (including subtalar, talonavicular, and calcaneocuboid joints, alone or in combination).
This device is supplied by Biomimetic Therapeutics, LLC and has received FDA PMA approval (P100006). It is classified as a Class III device under product code NOX and is intended for patients with preoperative or intraoperative evidence indicating the need for supplemental graft material due to various arthritic or structural joint conditions.
Frequently asked questions
What is Augment Bone Graft made of?
Augment Bone Graft is a synthetic peptide bone void filler, as specified in the generic name and device name fields, which identify it as a filler for bone void composed of synthetic peptide material.
For which joints is Augment Bone Graft indicated?
Augment Bone Graft is indicated for use in arthrodesis procedures of the ankle (tibiotalar joint) and/or hindfoot, including the subtalar, talonavicular, and calcaneocuboid joints, either alone or in combination, based on the approval statement in the device data.
Is Augment Bone Graft a replacement for autograft?
Yes, Augment Bone Graft is indicated for use as an alternative to autograft in arthrodesis procedures, meaning it is intended to replace the need for harvesting bone from the patient’s own body in ankle and hindfoot fusion surgeries.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P100006 | Class III | Active |
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Manufacturer
- Manufacturer
- Biomimetic Therapeutics, LLC
Sources (1)
- FDA PMA P100006 24 fields · synced Oct 6, 2026