# K250163: T2 Alpha Femur Retrograde Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Aug 13, 2025 after 204 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: 20 generations back to K954385 (1996). 331 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 334 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203819: T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System, Stryker GmbH (2021) Summary page 5.
- K201346: DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm, Synthes (USA) Products, LLC (2020) Summary page 5.
- K160545: Gap Endo-Exo Medullary System, Pega Medical, Inc. (2016) Summary page 5.
- K231262: Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System, Stryker GmbH (2023) Summary page 5.

## Most influential descendants
- K253640: T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (2026), 1 descendant of its own
- K261481: Pangea Femur Reconstruction System (2026), 0 descendants of its own

## Indications for use
The indications for use of these internal fixation devices include: - Open and closed femoral fractures - Pseudoarthrosis and correction osteotomy - Pathologic fractures, impending pathologic fractures and tumor resections - Supracondylar fractures, including those with intraarticular extension - Fractures involving osteopenic and osteoporotic bone - Fractures distal to a total hip prosthesis - Periprosthetic fractures - Nonunions and malunions The struts of the T2 Alpha Femur Retrograde Nailing System are intended to be used only with the nails of this system; they are not to be used as stand-alone devices.

Source page: https://510kreport.com/device/K250163
Methodology: https://510kreport.com/methodology