# K151543: Graft Delivery Device with Integrated Stylet

- Pathway: 510(k) (Special)
- Applicant: Micromedics, Inc. (D/B/A Nordson Medical)
- Decided: Jul 7, 2015 after 29 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.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100754: Graft Delivery System Model SA-6115, Micromedics, Inc. (2010) Summary page 4.
- K072330: Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation System, Biomet, Inc. (2007) Summary page 4.

## Indications for use
The graft preparation and delivery device is intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as IV fluids, blood, plasma concentrate, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.

Source page: https://510kreport.com/device/K151543
Methodology: https://510kreport.com/methodology