The latest expansion received FDA 510(k) clearance in June 2023.
Since its 2022 launch, Gamma4 has been used in more than 19,000 cases across more than 850 facilities. Kalamazoo, Michigan-based Stryker now incorporates the RC Lag screw and an anti-rotation clip with sleeve components in the Gamma4.
Gamma4 is indicated for the treatment of stable and unstable fractures. It also offers an option for the stabilization of bones and correction of bone deformities. This extends to cases with the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur.
New features of Gamma4 include increased cutout resistance. Stryker says the new screw increases this by 15% compared to the standard Gamma4 lag screw. Additionally, it offers increased fixation, with 2mm of additional surface area contact within the femoral head.
Stryker’s new intermediate nail option offers more isthmus support than a trochanteric nail. It also enables faster procedural time compared to a long nail. Gamma4 also now has controlling intraoperative rotation. Its anti-rotation clip and sleeve components offer intraoperative stability in rotationally unstable femoral head neck fragments.
“The Gamma4 System, with its rich 30-year legacy of innovation and clinical history, has ushered in a new era of intramedullary nailing systems for hip fractures,” said Eric Tamweber, VP and GM of Stryker’s Trauma business. “Stryker remains unwavering in our commitment to providing cutting-edge orthopedic solutions to meet the needs of our customers. While Gamma4 has already made a significant impact, the new line extension expands our nailing portfolio and provides surgeons with options that are designed to streamline operative flow and improve procedural efficiency.”
