# K121476: Infill Graft Delivery System

- Pathway: 510(k) (Special)
- Applicant: Pinnacle Spine Group, LLC
- Decided: Aug 29, 2012 after 103 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: 6 generations back to K013966 (2002). 17 ancestors in all.
40 later devices descend from it; 4 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111632: Infill Graft Delivery System, Pinnacle Spine Group, LLC (2011) Summary page 2.

## Most influential descendants
- 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
- K142661: Bi-Portal Bone Graft Delivery Device (2014), 15 descendants of its own
- K170675: Graftgun Universal Graft Delivery System (2017), 11 descendants of its own

## Indications for use
The InFillTM Graft Delivery System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site.

Source page: https://510kreport.com/device/K121476
Methodology: https://510kreport.com/methodology