# K161568: Bone Solutions Mixing and Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Bone Solutions, Inc.
- Decided: Sep 16, 2016 after 101 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: 9 generations back to K013966 (2002). 26 ancestors in all.
21 later devices descend from it; 3 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141245: Etex Mixing and Delivery System, Etex Corporation (2014) Summary page 4.

## Most influential descendants
- K170675: Graftgun Universal Graft Delivery System (2017), 11 descendants of its own
- K181255: PRODENSE Bone Graft Substitute (2018), 7 descendants of its own
- K180937: Graftgun Universal Graft Delivery System (2018), 6 descendants of its own
- K182823: PRODENSE Bone Graft Substitute (2018), 5 descendants of its own
- K212083: Tactoset Injectable Bone Substitute (2021), 2 descendants of its own

## Indications for use
The Bone Solutions Mixing and 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/K161568
Methodology: https://510kreport.com/methodology