# K200606: O-Genesis Graft Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: May 1, 2020 after 53 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: 11 generations back to K013966 (2002). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170675: Graftgun Universal Graft Delivery System, SurGenTec, LLC (2017) Summary page 4.

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

Source page: https://510kreport.com/device/K200606
Methodology: https://510kreport.com/methodology