# K221808: InterOss Collagen

- Pathway: 510(k) (Traditional)
- Applicant: Sigmagraft, Inc.
- Decided: Mar 18, 2023 after 269 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: 4 generations back to K871773 (1987). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142040: Ocs-B Collagen, Nibec Co., Ltd. (2015) Summary page 4.

## Indications for use
InterOss® Collagen is indicated for filling of extraction sockets to enhance preservation of the alveolar ridge. InterOss Collagen is recommended for: Filling of extraction sockets to enhance preservation of the alveolar ridge Filling of periodontal defects in extraction sockets in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)

Source page: https://510kreport.com/device/K221808
Methodology: https://510kreport.com/methodology