# K234075: Flow-Nail

- Pathway: 510(k) (Special)
- Applicant: Flow-Fx, LLC
- Decided: Feb 5, 2024 after 26 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- 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 K970097 (1997). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221115: Flow-Nail, Flow-Fx, LLC (2022) Summary page 5.

## Indications for use
The Flow-Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric, and high subtrochanteric fractures and combinations of these fractures. The Flow-Nail can also be used to deliver injectable bone void fillers to a surgical site.

Source page: https://510kreport.com/device/K234075
Methodology: https://510kreport.com/methodology