Design innovations pioneered by Stryker elevate one of the most basic spinal surgery tools, with the goal of reducing work, increasing speed, and enhancing surgical efficiency. The Serrato pedicle screw is the first dual-thread screw with enhanced cutting flutes (serrations) that are designed to reduce work by lowering the insertion torque,1 and True-Tip geometry, which allows for precise insertion and immediate bone engagement.1
“We are thrilled to announce the full commercial launch of the Serrato pedicle screw during this important spinal surgery conference,” said Bradley Paddock, President of Stryker’s Spine division. “We have been receiving exceptional feedback from our surgeon customers since the initial launch and are excited to now make Serrato more broadly available to surgeons.”
According to Alexander R. Vaccaro, M.D., Ph.D., MBA, one of the first surgeons to integrate Serrato, “The Serrato pedicle system from Stryker has added a new level of versatility to the armamentarium that a spine surgeon has in all complex spinal procedures. The new screw design affords excellent screw purchase.”
The Serrato pedicle screw, part of Stryker’s Xia 3 Spinal System, received 510(k) clearance from the U.S. Food and Drug Administration in May 2017. The screws accommodate a variety of rod diameters and materials to suit the patient’s needs—5.5 and 6.0mm diameter rods in commercially pure titanium, titanium alloy, and Vitallium.
The Xia 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia 3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, and failed previous fusion. For the full Indications for Use, please refer to the Xia 3 Spinal System Instructions for Use.
1Serrato Claims Validation Report | DHF 0000052658