# P100006: Augment Bone Graft

- Pathway: PMA
- Applicant: Biomimetic Therapeutics, LLC
- Decided: Sep 1, 2015 after 2,035 days
- Product code: NOX (Filler, Bone Void, Synthetic Peptide)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jul 23, 2021 · Class II · Z-2335-2021: The kit contains the wrong vial tray in the package.

Source page: https://510kreport.com/device/P100006
Methodology: https://510kreport.com/methodology