# K221737: InstaFill Graft Delivery System, SIGNIFY Bioactive

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Aug 11, 2022 after 57 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: 12 generations back to K960978 (1996). 85 ancestors in all.
No later device cites it as a predicate yet.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180937: Graftgun Universal Graft Delivery System, SurGenTec, LLC (2018) Summary page 4.
- K170675: Graftgun Universal Graft Delivery System, SurGenTec, LLC (2017) Summary page 4.
- K130977: Signify Bioactive, Globus Medical, Inc. (2013) Summary page 4.

## Indications for use
The InstaFillm 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/K221737
Methodology: https://510kreport.com/methodology