# K160978: LITe BIO Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Jul 8, 2016 after 92 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 K960978 (1996). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121124: Arthrex Mixing and Delivery System, Arthrex, Inc. (2012) Summary page 4.
- K140710: Biomet Graft Delivery Syringes, Biomet Spine (Aka Ebi, LLC) (2014) Summary page 4.
- K112773: Novabne Putty Bioactive Synthetic Bone Graft, Novabone Products, LLC (2011) Summary page 4.

## Indications for use
The LITe® BIO Delivery System is intended to deliver autograft, allograft, or synthetic bone grafting materials to all orthopedic surgical sites.

Source page: https://510kreport.com/device/K160978
Methodology: https://510kreport.com/methodology