# K082498: Graftys HBS

- Pathway: 510(k) (Abbreviated)
- Applicant: Graftys
- Decided: Feb 25, 2009 after 180 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011897 (2001). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011897: Norian SRS Bone Void Filler, Synthes (Usa) (2001)

## Most influential descendants
- K093343: Grafty Quickset (2010), 1 descendant of its own
- K231714: Graftys Quickset (2023), 0 descendants of its own

## Indications for use
GRAFTYS®HBS is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS®HBS is intended to be placed or injected into bony voids or gaps of the skeletal system (the extremities and the pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K082498
Methodology: https://510kreport.com/methodology