# K244006: FG Bone Graft M

- Pathway: 510(k) (Traditional)
- Applicant: Full Golden Biotech Co., Ltd.
- Decided: Sep 17, 2025 after 265 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 6.

## Indications for use
FG Bone Graft M is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Typical uses include: - Periodontal/Intrabony defects filling - Ridge augmentation - Implant preparation, placement in extraction sites - Sinus lifts - Cystic cavities filling

Source page: https://510kreport.com/device/K244006
Methodology: https://510kreport.com/methodology