# K201338: Allograft MIS Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Lifenet Health
- Decided: Jul 13, 2020 after 54 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: 12 generations back to K013966 (2002). 30 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180937: Graftgun Universal Graft Delivery System, SurGenTec, LLC (2018) Summary page 4.

## Most influential descendants
- K241426: GPS Advanced; 5 cc GPS Advanced Cannula (2024), 1 descendant of its own
- K251648: GPS Advanced; GPS Advanced Cannula (2025), 0 descendants of its own

## Indications for use
The Allograft MIS Delivery System is intended to be used for the delivery of hydrated allograft bone graft material to an orthopedic surgical site.

Source page: https://510kreport.com/device/K201338
Methodology: https://510kreport.com/methodology