# K043261: Harvest Graft Delivery Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Harvest Technologies, Corp.
- Decided: Mar 11, 2005 after 107 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K013966 (2002). 8 ancestors in all.
51 later devices descend from it; 4 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003286: Symphony Graft Delivery System, Depuyacromed (2001) Summary page 1.
- K023088: Bone Graft Syringe, Model 8600-00X0, Wrightmedicaltechnologyinc (2002) Summary page 1.
- K031817: Cellplex TCP Synthetic Cancellous Bone, Wrightmedicaltechnologyinc (2003) Summary page 1.
- K041991: Aspirex - Bone Marrow Aspirate Kit, Isotis Orthobiologics, Inc. (2004) Summary page 1.

## Most influential descendants
- K100754: Graft Delivery System Model SA-6115 (2010), 45 descendants of its own
- K111632: Infill Graft Delivery System (2011), 41 descendants of its own
- K121476: Infill Graft Delivery System (2012), 40 descendants of its own
- K062986: Medtronic Graft Delivery Syringe (2006), 37 descendants of its own
- K121124: Arthrex Mixing and Delivery System (2012), 36 descendants of its own

## Recalls of this device
- Oct 20, 2017 · Class II · Z-0075-2018: Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch.
- Sep 11, 2013 · Class II · Z-0022-2014: Potential for leur connector to leak or have cracks.

## Indications for use
The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for the delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with the aspirate(s), 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/K043261
Methodology: https://510kreport.com/methodology