# K012738: Symphony Graft Delivery System (GDS)

- Pathway: 510(k) (Traditional)
- Applicant: Depuyacromed
- Decided: Nov 14, 2001 after 90 days
- Product code: GEY (Motor, Surgical Instrument, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 878.4820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003286 (2001). 2 ancestors in all.
38 later devices descend from it; 2 cite it directly.
0 of 41 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.
- K010320: Modification to Symphony Graft Delivery System, Depuyacromed (2001) Summary page 1.

## Most influential descendants
- K062365: Arthrex Aspirate Kit (2006), 37 descendants of its own
- 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

## Indications for use
The Symphony Graft Delivery 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 1.V. 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/K012738
Methodology: https://510kreport.com/methodology