# K083372: Arrowbone-a, Arrowbone-B

- Pathway: 510(k) (Traditional)
- Applicant: Brainbase Corporation
- Decided: Dec 8, 2009 after 389 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: 4 generations back to K941780 (1995). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
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) Summary page 2.
- K050260: Bioresorb Macro Pore, Oraltronics Dental Implant Technology GmbH (2005) Summary page 2.

## Most influential descendants
- K110198: Blue Sky Bio TCP (2011), 0 descendants of its own

## Indications for use
Intended for use in reconstruction of natural or surgical periodontal defects of the oral and maxillofacial region, including sinus floor elevation and augmentation of the alveolar crest. Intended for filling into the site of a bony defect in combination with patient blood, autologous bone, membranes or sterile saline after removal of cysts or surgical removal of retained teeth.

Source page: https://510kreport.com/device/K083372
Methodology: https://510kreport.com/methodology