# K140710: Biomet Graft Delivery Syringes

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Spine (Aka Ebi, LLC)
- Decided: Sep 4, 2014 after 167 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: 7 generations back to K013966 (2002). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072330: Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation System, Biomet, Inc. (2007) Summary page 4.
- K121124: Arthrex Mixing and Delivery System, Arthrex, Inc. (2012) Summary page 4.
- K121476: Infill Graft Delivery System, Pinnacle Spine Group, LLC (2012) Summary page 4.
- K111632: Infill Graft Delivery System, Pinnacle Spine Group, LLC (2011) Summary page 4.
- K021071: PCCS Graft Delivery System, Biomet, Inc. (2002) Summary page 4.

## Most influential descendants
- K160978: LITe BIO Delivery System (2016), 0 descendants of its own

## Indications for use
The Biomet Graft Delivery Syringes are intended to deliver autograft, allograft or synthetic bone grafting materials to all orthopedic surgical sites.

Source page: https://510kreport.com/device/K140710
Methodology: https://510kreport.com/methodology