# K142535: ConMed Mixing and Delivery Kit

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Corporation
- Decided: Apr 23, 2015 after 226 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: 6 generations back to K013966 (2002). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 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 4.

## Indications for use
The CONMED Mixing and Delivery Kit is intended for 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 IV 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/K142535
Methodology: https://510kreport.com/methodology