# K110198: Blue Sky Bio TCP

- Pathway: 510(k) (Traditional)
- Applicant: Blue Sky Bio, LLC
- Decided: Dec 22, 2011 after 332 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 K941780 (1995). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051443: Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio, Curasan Ag, Frankfurt Facility (2005)
- K083372: Arrowbone-a, Arrowbone-B, Brainbase Corporation (2009) Summary page 6.

## Indications for use
Blue Sky Bio TCP Bone Graft Substitute is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects. Filling of periodontal/infrabony defects Ridge augmentation Filling of extraction sites (implant preparation/placement) Sinus lifts Filling of cystic cavities The device gradually resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K110198
Methodology: https://510kreport.com/methodology