# K230352: Tornier Humeral Nail and Tornier Long Humeral Nail

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Oct 31, 2023 after 264 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). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133376: Aequalis Humeral Nail; Sizes 7MM & 8MM X 210, 230, 250, 270MM; Left and Right, Tornier, Inc. (2013) Summary page 4.

## Most influential descendants
- K251400: T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System (2025), 0 descendants of its own

## Indications for use
The Tornier Humeral Nail System is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact humeral head, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).

Source page: https://510kreport.com/device/K230352
Methodology: https://510kreport.com/methodology