# K190996: Bonus Therapeutics Mixing and Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Bonus Therapeutics, Ltd.
- Decided: Jul 28, 2019 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: 9 generations back to K013966 (2002). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 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.

## Indications for use
The Bonus Therapeutics Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to surgical sites.

Source page: https://510kreport.com/device/K190996
Methodology: https://510kreport.com/methodology