# K170675: Graftgun Universal Graft Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: SurGenTec, LLC
- Decided: Jul 19, 2017 after 135 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: 10 generations back to K013966 (2002). 28 ancestors in all.
11 later devices descend from it; 7 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161568: Bone Solutions Mixing and Delivery System, Bone Solutions, Inc. (2016) Summary page 4.
- K142661: Bi-Portal Bone Graft Delivery Device, Spinal Surgical Strategies, LLC (2014) Summary page 4.

## Most influential descendants
- K180937: Graftgun Universal Graft Delivery System (2018), 6 descendants of its own
- K201338: Allograft MIS Delivery System (2020), 2 descendants of its own
- K243580: GraftGun Universal Graft Delivery System (GDS) (2025), 1 descendant of its own
- K241426: GPS Advanced; 5 cc GPS Advanced Cannula (2024), 1 descendant of its own
- K200431: 3D GraftRasp System (2020), 1 descendant of its own

## Indications for use
The Graftgun Universal Graft Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

Source page: https://510kreport.com/device/K170675
Methodology: https://510kreport.com/methodology