# K231714: Graftys Quickset

- Pathway: 510(k) (Special)
- Applicant: Graftys
- Decided: Jul 12, 2023 after 30 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: 3 generations back to K011897 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093343: Grafty Quickset, Graftys (2010) Summary page 4.

## Indications for use
GRAFTYS® QUICKSET is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS® QUICKSET is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., the extremities and 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/K231714
Methodology: https://510kreport.com/methodology