# K241484: Atlas™ Humeral Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Orthopedic Designs North America, Inc. (Odi-Na)
- Decided: Nov 5, 2024 after 165 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: 2 generations back to K033071 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173255: Talon DistalFix Humeral Nail, Orthopedic Designs North America, Inc. (2018) Summary page 5.

## Indications for use
The Atlas™ 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/K241484
Methodology: https://510kreport.com/methodology