# K253640: T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Feb 3, 2026 after 76 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: 21 generations back to K954385 (1996). 332 ancestors in all.
1 later device descends 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)
- K250163: T2 Alpha Femur Retrograde Nailing System, Stryker GmbH (2025) 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
- K261481: Pangea Femur Reconstruction System (2026), 0 descendants of its own

## Indications for use
The T2 Alpha Femur Retrograde Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved. 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 Pangea Femur Reconstruction System is indicated for the internal fixation and stabilization of femur bone fractures and osteotomies in normal and osteopenic bone, including: • Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures. • Non-unions, malunions, and deformities. • Peri-implant fractures. When used with the T2 Alpha Femur Retrograde Nailing System, the Pangea Femur Reconstruction System is used for the indications of the T2 Alpha Femur Retrograde Nailing System.

Source page: https://510kreport.com/device/K253640
Methodology: https://510kreport.com/methodology