# K141245: Etex Mixing and Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Etex Corporation
- Decided: Jul 9, 2014 after 56 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: 8 generations back to K013966 (2002). 25 ancestors in all.
31 later devices descend from it; 3 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133021: Mixing Syringe System, Zimmer Knee Creations, Inc. (2014) Summary page 2.
- K121124: Arthrex Mixing and Delivery System, Arthrex, Inc. (2012) Summary page 2.

## Most influential descendants
- 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
- K181255: PRODENSE Bone Graft Substitute (2018), 7 descendants of its own
- K180937: Graftgun Universal Graft Delivery System (2018), 6 descendants of its own

## Indications for use
The ETEX Mixing and 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/K141245
Methodology: https://510kreport.com/methodology