# K153676: Osteon Iii

- Pathway: 510(k) (Traditional)
- Applicant: Genoss Co., Ltd.
- Decided: Sep 14, 2016 after 268 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- 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 K990131 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051885: MBCP, Biomatlante (2005) Summary page 4.

## Indications for use
OSTEON III is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects. - Periodontal/infrabony defects - Ridge augmentation - Extraction Sites(implant preparation/ placement) - Sinus lifts - Cystic cavities

Source page: https://510kreport.com/device/K153676
Methodology: https://510kreport.com/methodology