# K173255: Talon DistalFix Humeral Nail

- Pathway: 510(k) (Traditional)
- Applicant: Orthopedic Designs North America, Inc.
- Decided: Feb 22, 2018 after 135 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: 1 generation back to K033071 (2003). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033071: Synthes (Usa) Cannulated Titanium Humeral Nail System, Synthes (Usa) (2003) Summary page 5.

## Most influential descendants
- K241484: Atlas™ Humeral Nail System (2024), 0 descendants of its own

## Indications for use
The Talon™ DistalFix™ Humeral Nail System is indicated to aid in the alignment and stabilization of humeral fractures, including: * Diaphyseal fractures of the humeral shaft * Proximal humeral fractures with diaphyseal extension * Impending pathologic fractures

Source page: https://510kreport.com/device/K173255
Methodology: https://510kreport.com/methodology