# K193308: T2 Alpha Tibia Nailing System, IMN Screws System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Trauma GmbH
- Decided: Feb 23, 2020 after 86 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). 35 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 6.
- K003018: Titan Tibial Nail, Howmedica Osteonics Corp. (2000) Summary page 6.
- K040762: Synthes (Usa) Tibial Nail System EX, Synthes (Usa) (2004) Summary page 6.

## Most influential descendants
- K213328: Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System (2022), 3 descendants of its own
- K251400: T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System (2025), 0 descendants of its own
- K230512: Gamma4 System (2023), 0 descendants of its own
- K222309: Gamma4 System (2022), 0 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.

Source page: https://510kreport.com/device/K193308
Methodology: https://510kreport.com/methodology