# K992856: Magellan Humeral Intramedullary Nail

- Pathway: 510(k) (Traditional)
- Applicant: Orthomatrix, Inc.
- Decided: Mar 10, 2000 after 199 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The MAGELLAN™ Intramedullary Humeral Nail System is indicated for use in long bone shaft fractures of the humerus which require stabilization of the axis of the bone. These include shaft fractures, segmented fractures, fractures with bone loss, comminuted fractures, proximal and distal fractures, non-unions and malunions.

Source page: https://510kreport.com/device/K992856
Methodology: https://510kreport.com/methodology