# K101014: Bond Bone

- Pathway: 510(k) (Traditional)
- Applicant: Mis Implants Technologies, Ltd.
- Decided: Oct 21, 2010 after 192 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: 1 generation back to K083858 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083858: Bond Bone, Augma Biomaterials, Ltd. (2009) Summary page 2.

## Indications for use
Bond BoneTrm 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 bsseous defect, and to provide a resorbable barrier over other bone graft material.

Source page: https://510kreport.com/device/K101014
Methodology: https://510kreport.com/methodology