# K252016: Arthrex Humeral Nails

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Mar 20, 2026 after 266 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: 4 generations back to K951740 (1995). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050241: Aos Humeral Nail, Advanced Orthopaedic Solutions, Inc. (2005) Summary page 5.
- K090478: Aos Proximal Humeral Nail, Advanced Orthopaedic Solutions, Inc. (2009) Summary page 5.
- K103002: Synthes Multiloc Proximal Humeral Nailing System, Synthes (Usa) (2011) Summary page 5.

## Indications for use
The Arthrex Humeral Nail System is intended to treat stable and unstable proximal fractures of the humerus including two and three, and in some cases, four part humerus fractures. The Humeral Nail is also intended to treat proximal and distal one third fractures, midshaft fractures and pathological fractures.

Source page: https://510kreport.com/device/K252016
Methodology: https://510kreport.com/methodology