# K191271: T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System

- Pathway: 510(k) (Special)
- Applicant: Stryker Trauma GmbH
- Decided: Jun 11, 2019 after 29 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: 7 generations back to K970097 (1997). 34 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180436: T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System, Stryker Trauma GmbH (2018) Summary page 8.

## Most influential descendants
- K200869: Gamma3 System (2020), 9 descendants of its own
- 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 (2021), 7 descendants of its own
- K193308: T2 Alpha Tibia Nailing System, IMN Screws System (2020), 4 descendants of its own
- K213328: Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System (2022), 3 descendants of its own
- K250163: T2 Alpha Femur Retrograde Nailing System (2025), 2 descendants of its own

## Indications for use
The indications for use of these internal fixation devices include: - Fixation of subtrochanteric. intertrochanteric. ipsilateral neck/shaft. comminuted proximal femoral shaft fractures - Femoral fixation required as a result of pathological disease - Temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur - Open and closed femoral fractures - Pseudoarthrosis and correction osteotomy - Pathologic fractures. impending pathologic fractures and tumor resections - Ipsilateral femur fractures - Fractures proximal to a total knee arthroplasty - Nonunions and malunions - Fractures involving osteopenic and osteoporotic bone The indications for use of this internal fixation device include: - Open and closed tibial fractures - Pseudoarthrosis and correction osteotomy - Pathologic fractures, impending pathologic fractures. and tumor resections - Fractures involving osteopenic and osteoporotic bone - Nonunion and malunion The End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF may also be used in conjunction with the T2 Alpha Femur Antegrade GT/PF Nailing System. The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization. The IMN Instruments System is intended to enable the implantation and extraction of intramedullary nail and screw.

Source page: https://510kreport.com/device/K191271
Methodology: https://510kreport.com/methodology