# K121124: Arthrex Mixing and Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: May 16, 2012 after 33 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: 5 generations back to K013966 (2002). 16 ancestors in all.
36 later devices descend from it; 5 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062986: Medtronic Graft Delivery Syringe, Medtronic Sofamor Danek USA, Inc. (2006) Summary page 1.
- K012738: Symphony Graft Delivery System (GDS), Depuyacromed (2001) Summary page 1.
- K062365: Arthrex Aspirate Kit, Arthrex, Inc. (2006) Summary page 1.

## Most influential descendants
- K133021: Mixing Syringe System (2014), 32 descendants of its own
- K141245: Etex Mixing and Delivery System (2014), 31 descendants of its own
- K161568: Bone Solutions Mixing and Delivery System (2016), 21 descendants of its own
- K170675: Graftgun Universal Graft Delivery System (2017), 11 descendants of its own
- K161447: HydroSet XT (2016), 10 descendants of its own

## Indications for use
The Arthrex Mixing and Delivery System is indicated for the delivery of allograft, autograft, or synthetic bone graft materials to all orthopedic surgical sites. In addition, it is designed to facilitate pre-mixing of allograft, autograft, or synthetic bone graft materials with I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.

Source page: https://510kreport.com/device/K121124
Methodology: https://510kreport.com/methodology