# K172774: T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Trauma GmbH
- Decided: Jan 12, 2018 after 120 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: 5 generations back to K970097 (1997). 25 ancestors in all.
17 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102992: T2 Recon Nail, R1500, Left/Right 125 Degrees / 120 Degrees / 130 Degrees, Howmedica Osteonics Corp. (2010) Summary page 7.
- K101438: T2 Greater Trochanter Nail, Howmedica Osteonics Corp. (2010) Summary page 7.
- K083497: Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails, Zimmer, Inc. (2009) Summary page 7.
- K003018: Titan Tibial Nail, Howmedica Osteonics Corp. (2000) Summary page 7.
- K123401: GAMMA3 and T2 Recon Targeting Devices, Stryker Trauma AG (2013) Summary page 7.

## Most influential descendants
- K180436: T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (2018), 16 descendants of its own
- K191271: T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System (2019), 15 descendants of its own
- 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

## Indications for use
The indications for use of these internal fixation devices include: - Fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, comnunuted 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 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/K172774
Methodology: https://510kreport.com/methodology