# K210997: PreferX Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Md3, LLC
- Decided: Sep 7, 2021 after 158 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: 11 generations back to K013966 (2002). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 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 4.

## Indications for use
The PREFERX 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/K210997
Methodology: https://510kreport.com/methodology