# K082286: Bioactys

- Pathway: 510(k) (Abbreviated)
- Applicant: Graftys
- Decided: Feb 24, 2009 after 197 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: 6 generations back to K990131 (1999). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051885: MBCP, Biomatlante (2005) Summary page 1.
- K073064: Graftys BCP, Graftys (2008) Summary page 1.

## Most influential descendants
- K103820: Reprobone Dental Grafting Material (2011), 0 descendants of its own

## Indications for use
Bioactys ® is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. These defects may be surgically created osseous or defects created from traumatic injury to bone.

Source page: https://510kreport.com/device/K082286
Methodology: https://510kreport.com/methodology