# K191737: The Graft Bone Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Purgo Biologics, Inc.
- Decided: Feb 14, 2020 after 231 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: 5 generations back to K871773 (1987). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173188: The Graft Natural Bone Substitute, Purgo Biologics, Inc. (2018) Summary page 4.
- K162158: Porcine Anorganic Bone Mineral in Delivery Applicator, Collagen Matrix, Inc. (2017) Summary page 4.

## Indications for use
The Graft Bone Substitute is intended for use as a bone grafting material in dental surgery such as: - Filling of extraction sockets to enhance preservation of the alveolar ridge - Elevation of maxillary sinus floor

Source page: https://510kreport.com/device/K191737
Methodology: https://510kreport.com/methodology