# K222309: Gamma4 System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Nov 15, 2022 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: 10 generations back to K970097 (1997). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213328: Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System, Stryker GmbH (2022) Summary page 5.

## 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).

Source page: https://510kreport.com/device/K222309
Methodology: https://510kreport.com/methodology