# 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

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Feb 26, 2021 after 59 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: 8 generations back to K970097 (1997). 53 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200880: T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System, Stryker GmbH (2020) Summary page 9.
- K101622: Zimmer Natural Nail System Retrograde Femoral Nails, Zimmer, Inc. (2010) Summary page 9.
- K191271: T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System, Stryker Trauma GmbH (2019) Summary page 9.

## Most influential descendants
- 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
- 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
- K251400: T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System (2025), 0 descendants of its own

## Indications for use
The indications for use of this internal fixation device include: • Open and closed femoral fractures • Pseudoarthrosis and correction osteotomy • Pathologic fractures, impending pathologic fractures, and tumor resections • Supracondylar fractures, including those with intra-articular extension • Fractures involving osteopenic and osteoporotic bone • Fractures distal to a total hip prosthesis • Periprosthetic fractures • Nonunions and malunions 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 Compression Screw Femur may also be used in conjunction with the T2 Alpha Femur Retrograde System. The T2 Tibial Nailing System is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The T2 Tibial Nailing System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following: • Open and closed tibial fractures • Pseudoarthrosis and correction osteotomy • Pathologic fractures, impending pathologic fractures, and tumor resections • Nonunion and malunion The Locking Screws may also be used in conjunction with the T2 Alpha Systems. The T2 Femoral Nail is indicated for long bone fracture fixation specifically femoral fracture fixation which may include the following: • Open and closed femoral fractures • Pseudoarthrosis and correction osteotomy • Pathologic fractures, impending pathologic fractures, and tumor resections • Supracondylar fractures, including those with intra-articular extension • Ipsilateral femur fractures • Fractures proximal to a total knee arthroplasty • Fractures distal to hip joint • Nonunions and malunions The Condyle Nut and Condyle Screws may also be used in conjunction with the T2 Alpha Femur Retrograde System. The T2 Supracondylar Nail System is indicated for: • Open and closed femoral fractures • Pseudoarthrosis and correction osteotomy • Pathologic fractures, impending pathologic fractures, and tumor resections • Supracondylar fractures including those with intra-articular extension • Fractures distal to a total hip prosthesis • Nonunions and malunions The End Cap may also be used in conjunction with the T2 Alpha Femur Retrograde System.

Source page: https://510kreport.com/device/K203819
Methodology: https://510kreport.com/methodology