# K121177: Bond Apatite

- Pathway: 510(k) (Traditional)
- Applicant: Augma Biomaterials, Ltd.
- Decided: Dec 5, 2013 after 596 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: 7 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)
- K083858: Bond Bone, Augma Biomaterials, Ltd. (2009) Summary page 2.
- K090871: Cerament Ibone Void Filler High Contrast, Model a 0210-12, Bonesupport AB (2009) Summary page 2.
- K910432: Hapset Hydroxylapatite Bone Graft Plaster, Lifecore Biomedical, Inc. (1991) Summary page 2.

## Indications for use
Bond Apatite is a synthetic osteoconductive, bioresorbable bone grafting material composed of hydroxyapatite and biphasic calcium sulfate in granulated powder form, intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Source page: https://510kreport.com/device/K121177
Methodology: https://510kreport.com/methodology