# K142776: Flow-Screw

- Pathway: 510(k) (Traditional)
- Applicant: Flow-Fx, LLC
- Decided: Mar 23, 2015 after 178 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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). 80 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962823: Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer, Synthes (Usa) (1996) Summary page 4.
- K962011: Synthes 7.0/7.3 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 4.
- K102528: N-Force Fixation System, Innovision, Inc. (2011) Summary page 4.
- K132244: N-Force Fixation System, Innovision, Inc. (2014) Summary page 4.

## Most influential descendants
- K173556: Injection Screw (2018), 0 descendants of its own

## Indications for use
The Flow-Screw is intended for the fixation of bone fractures and bone reconstructions. When used for these indications, the Flow-Screw can also be used to deliver injectable bone void fillers to a surgical site.

Source page: https://510kreport.com/device/K142776
Methodology: https://510kreport.com/methodology