# K102015: Osteon, Osteon Sinus, Osteon Lifting

- Pathway: 510(k) (Special)
- Applicant: Genoss Co., Ltd.
- Decided: Nov 19, 2010 after 126 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: 6 generations back to K990131 (1999). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062834: Osteon, Models GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050, Genoss Co., Ltd. (2007) Summary page 1.

## Indications for use
OSTEON, OSTEON Sinus, OSTEON Lifting are 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/K102015
Methodology: https://510kreport.com/methodology