# K262581: GraftGun Universal Graft Delivery System (GDS®)

- Pathway: 510(k) (Special)
- Applicant: SurGenTec, LLC
- Decided: Aug 26, 2026 after 30 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K013966 (2002). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170675: Graftgun Universal Graft Delivery System, SurGenTec, LLC (2017) Summary page 5.
- K180937: Graftgun Universal Graft Delivery System, SurGenTec, LLC (2018) Summary page 5.
- K243580: GraftGun Universal Graft Delivery System (GDS), SurGenTec, LLC (2025) Summary page 5.

## Indications for use
The GraftGun Universal Graft Delivery System (GDS®) is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site, via direct visualization or minimally invasive.

Source page: https://510kreport.com/device/K262581
Methodology: https://510kreport.com/methodology