# K133021: Mixing Syringe System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Knee Creations, Inc.
- Decided: Jan 13, 2014 after 109 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: 7 generations back to K013966 (2002). 24 ancestors in all.
32 later devices descend from it; 1 cites 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)
- K121124: Arthrex Mixing and Delivery System, Arthrex, Inc. (2012) Summary page 1.
- K121476: Infill Graft Delivery System, Pinnacle Spine Group, LLC (2012) Summary page 1.
- K111632: Infill Graft Delivery System, Pinnacle Spine Group, LLC (2011) Summary page 2.

## Most influential descendants
- 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
- K181255: PRODENSE Bone Graft Substitute (2018), 7 descendants of its own

## Indications for use
The Mixing Syringe 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/K133021
Methodology: https://510kreport.com/methodology