# K140601: Flow-Nail

- Pathway: 510(k) (Traditional)
- Applicant: Flow-Fx, LLC
- Decided: Jul 2, 2014 after 114 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: 7 generations back to K970097 (1997). 29 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120715: Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short, Zimmer GmbH (2012) Summary page 1.
- K091566: Zimmer Natural Nail System Cephalomedullary Nails, Zimmer GmbH (2009) Summary page 1.
- K032244: Gamma 3 Nail System, Howmedica Osteonics Corp. (2003) Summary page 1.
- K103533: ES Trochanteric Nail, Left and Right, 10MM, Advanced Orthopaedic Solutions, Inc. (2011) Summary page 1.
- K021008: Advanced Orthopaedic Solutions Trochanteric Nail, Advanced Orthopaedic Solutions, Inc. (2002) Summary page 1.

## Most influential descendants
- K221115: Flow-Nail (2022), 1 descendant of its own
- K234075: Flow-Nail (2024), 0 descendants of its own

## 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/K140601
Methodology: https://510kreport.com/methodology