# K062986: Medtronic Graft Delivery Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Dec 8, 2006 after 70 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: 4 generations back to K013966 (2002). 11 ancestors in all.
37 later devices descend from it; 1 cites it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043261: Harvest Graft Delivery Syringe, Harvest Technologies, Corp. (2005) Summary page 1.
- K003286: Symphony Graft Delivery System, Depuyacromed (2001) Summary page 1.
- K011087: Orthovita Piston Syringe or Imbibe Bone Marrow Aspiration Syringe, Orthovita, Inc. (2001)
- K023074: Imbibe Bone Marrow Aspiration Syringe, Orthovita, Inc. (2003) Summary page 1.
- K030208: Imbibe II Syringe, Orthovita, Inc. (2003) Summary page 1.

## Most influential descendants
- K121124: Arthrex Mixing and Delivery System (2012), 36 descendants of its own
- K133021: Mixing Syringe System (2014), 32 descendants of its own
- 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

## Indications for use
The Medtronic Graft Delivery Syringe is intended to provide the surgeon with a means to mix autologous blood or bone marrow with allograft, autograft, demineralized bone, or synthetic bone graft materials and to deliver these materials to all orthopaedic surgical sites.

Source page: https://510kreport.com/device/K062986
Methodology: https://510kreport.com/methodology