# K083858: Bond Bone

- Pathway: 510(k) (Traditional)
- Applicant: Augma Biomaterials, Ltd.
- Decided: Mar 17, 2009 after 83 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K121177: Bond Apatite (2013), 0 descendants of its own
- K101014: Bond Bone (2010), 0 descendants of its own

## Indications for use
Bond Bone™ is indicated for use in the following ways: by itself in bone regenerative techniques, mixed with other suitable bone filling agents to prevent particle migration in an osseous defect, and to provide a resorbable barrier over other bone graft material.

Source page: https://510kreport.com/device/K083858
Methodology: https://510kreport.com/methodology