# P140019: I-Factor Peptide Enhanced Bone Graft

- Pathway: PMA
- Applicant: Cerapedics, LLC
- Decided: Nov 3, 2015 after 433 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
- Apr 14, 2022 · Class III · Z-1056-2022: Patient chart label contains incorrect Part Number and volume amount.

Source page: https://510kreport.com/device/P140019
Methodology: https://510kreport.com/methodology