# K230305: THE Graft Collagen

- Pathway: 510(k) (Traditional)
- Applicant: Purgo Biologics, Inc.
- Decided: Jul 24, 2024 after 537 days
- Product code: NPM (Bone Grafting Material, Animal Source)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K924408 (1995). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122894: Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich Perio System Combi Pack, Geistlic, Geistlich Pharma AG (2013) Summary page 5.

## Indications for use
THE Graft Collagen is recommended for: - Filling of extraction sockets to enhance preservation of the alveolar ridge.

Source page: https://510kreport.com/device/K230305
Methodology: https://510kreport.com/methodology