# K213328: Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Feb 11, 2022 after 129 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K970097 (1997). 61 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200869: Gamma3 System, Stryker Trauma GmbH (2020) Summary page 8.
- 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, Stryker GmbH (2021) Summary page 8.
- K192312: Zimmer Natural Nail System Cephalomedullary Nails, Zimmer GmbH (2019) Summary page 8.
- K193308: T2 Alpha Tibia Nailing System, IMN Screws System, Stryker Trauma GmbH (2020) Summary page 8.

## Most influential descendants
- 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

## Recalls of this device
- May 28, 2025 · Class II · Z-1914-2025: Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.

## Indications for use
The Gamma4 System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone). The Gamma3 System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone). The U-Blade Lag Screw is also indicated for rotationally unstable fractures. The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization. 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.

Source page: https://510kreport.com/device/K213328
Methodology: https://510kreport.com/methodology