# K060285: Bonegen - TR

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Lok Intl., Inc.
- Decided: Mar 16, 2006 after 41 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: 3 generations back to K960978 (1996). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011403: Surgiplaster Calcium Sulfate Hemihydrate, Orthogen Corp. (2001) Summary page 1.
- K041324: Calmatrix Calcium Sulfate Bone Graft Binder, Lifecore Biomedical, Inc. (2004) Summary page 1.
- K030288: Polygraft Bone Graft Substitute, Osteobiologics, Inc. (2003) Summary page 1.
- K982865: Atrisorb Bioabsorbable Guided Tissue Regeneration (GTR) Barrier Kit, Atrix Laboratories, Inc. (1998) Summary page 1.

## Most influential descendants
- K102208: Nanogen (2011), 0 descendants of its own

## Indications for use
1. Oral Surgery: Post-extraction. 2. Periodontics: Infra-osseous defects. 3. Endodontics: Apioectomy, Root perforations, Open apices. 4. Implantology: Dehiscences, fenestrations, sinus lifts.

Source page: https://510kreport.com/device/K060285
Methodology: https://510kreport.com/methodology