# K070055: Bonalive Granules and Bonalive Plates

- Pathway: 510(k) (Traditional)
- Applicant: Vivoxid, Ltd.
- Decided: Jun 25, 2007 after 172 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 K960978 (1996). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053387: Perioglas Bone Graft Particulate, Novabone Products, LLC (2006) Summary page 1.

## Most influential descendants
- K253883: Bonalive Maxillofacial (2026), 0 descendants of its own

## Indications for use
BonAlive™ Granules are sterile medical devices consisting of bioactive glass. Bioactive glass is a bone grafting material that is intended to fill, augment or reconstruct periodontal or bony defects. BonAlive™ Granules are indicated for use in the cranio-maxillofacial area including jaws.

Source page: https://510kreport.com/device/K070055
Methodology: https://510kreport.com/methodology