# K143488: InFill Graft Delivery System

- Pathway: 510(k) (Special)
- Applicant: Pinnacle Spine Group, LLC
- Decided: Dec 17, 2014 after 9 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). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121476: Infill Graft Delivery System, Pinnacle Spine Group, LLC (2012) Summary page 4.

## Indications for use
The InFill™ 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/K143488
Methodology: https://510kreport.com/methodology