# K251400: T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Aug 20, 2025 after 106 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: 10 generations back to K970097 (1997). 69 ancestors in all.
No later device cites it as a predicate yet.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032523: T2 Nailing System, Howmedica Osteonics Corp. (2003) Summary page 5.
- K230352: Tornier Humeral Nail and Tornier Long Humeral Nail, Tornier, Inc. (2023) Summary page 5.
- K213328: Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System, Stryker GmbH (2022) Summary page 5.

## Indications for use
The T2 Alpha Humerus Nailing System is indicated for the treatment of humerus fractures. Fractures can include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization. The T2 Humeral Nail is intended to provide temporary stabilization of various types of fractures, malunions, and non-unions of the humerus. The nails are inserted using an open or closed technique and can be static, dynamic, or compression locked. The subject and predicate devices are indicated for use in the humerus. Types of fractures include, but are not limited to, fractures of the humeral shaft, non-unions, malalignments, pathological humeral fractures, and impending pathological fractures.

Source page: https://510kreport.com/device/K251400
Methodology: https://510kreport.com/methodology