# K142661: Bi-Portal Bone Graft Delivery Device

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Surgical Strategies, LLC
- Decided: Dec 11, 2014 after 84 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.
15 later devices descend from it; 4 cite it directly.
0 of 34 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.

## Most influential descendants
- K170675: Graftgun Universal Graft Delivery System (2017), 11 descendants of its own
- K180937: Graftgun Universal Graft Delivery System (2018), 6 descendants of its own
- K201338: Allograft MIS Delivery System (2020), 2 descendants of its own
- K243580: GraftGun Universal Graft Delivery System (GDS) (2025), 1 descendant of its own
- K241426: GPS Advanced; 5 cc GPS Advanced Cannula (2024), 1 descendant of its own

## Indications for use
The Bi-Portal Bone Graft Delivery Device is intended to be used for the delivery of hydrated allograft or autograft to an orthopedic surgical site.

Source page: https://510kreport.com/device/K142661
Methodology: https://510kreport.com/methodology