# K200869: Gamma3 System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Trauma GmbH
- Decided: Jul 22, 2020 after 112 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). 41 ancestors in all.
9 later devices descend from it; 6 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123401: GAMMA3 and T2 Recon Targeting Devices, Stryker Trauma AG (2013) Summary page 4.
- 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 4.
- K172114: Zimmer Natural Nail System, Zimmer, Inc. (2017) Summary page 4.
- K040212: Trigen Intertan, Smith & Nephew, Inc. (2004) Summary page 4.
- K043431: GAMMA3 Nail System, Howmedica Osteonics Corp. (2005) Summary page 4.
- K034002: GAMMA3 Nail System, Howmedica Osteonics Corp. (2004) Summary page 4.

## Most influential descendants
- K213328: Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System (2022), 3 descendants of its own
- K242247: ARIX Femur Nail System (2025), 1 descendant of its own
- K261043: AUTOBAHN™ Nailing System (2026), 0 descendants of its own
- K252826: ARIX Femur Nail System (2025), 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 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.

Source page: https://510kreport.com/device/K200869
Methodology: https://510kreport.com/methodology