# K133376: Aequalis Humeral Nail; Sizes 7MM & 8MM X 210, 230, 250, 270MM; Left and Right

- Pathway: 510(k) (Special)
- Applicant: Tornier, Inc.
- Decided: Dec 5, 2013 after 31 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: 3 generations back to K951740 (1995). 8 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082754: Aequalis Humeral Nail System, Tornier (2009) Summary page 1.

## Most influential descendants
- K230352: Tornier Humeral Nail and Tornier Long Humeral Nail (2023), 1 descendant of its own
- K251400: T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System (2025), 0 descendants of its own
- K200127: TELEGRAPH® EVOLUTION Humeral Nailing System (2020), 0 descendants of its own

## Indications for use
The Tornier Aequalis 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/K133376
Methodology: https://510kreport.com/methodology