# K253883: Bonalive Maxillofacial

- Pathway: 510(k) (Special)
- Applicant: Bonalive, Ltd.
- Decided: May 14, 2026 after 161 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 K960978 (1996). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070055: Bonalive Granules and Bonalive Plates, Vivoxid, Ltd. (2007) Summary page 6.

## Indications for use
Bonalive@ Maxillofacial is a sterile medical device consisting of bioactive glass. Bioactive glass is a bone grafting material that is intended to fill, augment or reconstruct bony defects. Bonalive@ Maxillofacial is indicated for use in the maxillofacial area.

Source page: https://510kreport.com/device/K253883
Methodology: https://510kreport.com/methodology