# K091722: Coaxial Applicator System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Mar 12, 2010 after 274 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: 2 generations back to K011032 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011032: Smartjet Bone Graft Liquid Applicator (Spray Tip), Model SK/S, Smartjet Bone Graft Liquid Applicator (Dual Lumen Cannula, Harvest Technologies, Corp. (2001)
- K020252: Smartjet Grafting Liquid Applicator, Models SK/S & LK/2, Harvest Technologies, Corp. (2002) Summary page 1.
- K883338: Surgical Sealant Applicator, Micromedics, Inc. (1988) Summary page 1.

## Indications for use
The CoAxial Applicator System is designed to facilitate pre-mixing of allograft, autograft, or synthetic bone graft materials for application to an orthopedic surgical site,,with autologous blood, plasma, platelet-rich plasma, or other specific blood component(s) as deemed necessary by the clinical use requirements. In addition, the CoAxial Applicator System is intended for the application of autologous blood, plasma, platelet-rich plasma, or other specific blood component(s), as deemed necessary by the surgeon's determination of the clinical use requirements to facilitate the preparation of soft tissue autograft or allograft material prior to the application of the graft material to a repair site.

Source page: https://510kreport.com/device/K091722
Methodology: https://510kreport.com/methodology