Stryker (NYSE:SYK) said today it won FDA 510(k) clearance for its Serrato pedicle screw, designed for use in the non-cervical spine as part of its Xia 3 spinal system.
The Serrato pedicle screws feature enhanced serrated cutting flutes, a dual-thread pattern with increased leads for rapid insertion and a buttress thread locking mechanism designed to reduce cross threading and screw head splaying, the Kalamazoo, Mich.-based company said.
“Pedicle screws have been used for decades with very few changes to their design. The design innovations incorporated into Serrato reinforce our commitment to making industry-leading investments focused on providing the advanced spinal products and differentiated technologies that our surgeon customers have come to expect,” Stryker spine division prez Bradley Paddock said in a press release.
Stryker said the newly cleared pedicle screws can be used with a variety of rod sizes.
Last month, Stryker said it won FDA 510(k) clearance for its MultiGen 2 radiofrequency energy generator designed for RF ablation procedures.
The MultiGen 2 generator is designed with double the industry standard for power to achieve its target temperature faster with fewer errors and increased reliability and efficiency, the company said.