# K180436: T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Trauma GmbH
- Decided: Jun 6, 2018 after 106 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: 6 generations back to K970097 (1997). 33 ancestors in all.
16 later devices descend from it; 1 cites 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)
- K003018: Titan Tibial Nail, Howmedica Osteonics Corp. (2000) Summary page 8.
- K082770: Zimmer Natural Nail System Tibial Nail, Zimmer, Inc. (2008) Summary page 8.
- K040762: Synthes (Usa) Tibial Nail System EX, Synthes (Usa) (2004) Summary page 8.
- K172774: T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System, Stryker Trauma GmbH (2018) Summary page 8.

## Most influential descendants
- 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
- K213328: Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System (2022), 3 descendants of its own

## Indications for use
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. 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

Source page: https://510kreport.com/device/K180436
Methodology: https://510kreport.com/methodology