Stryker’s Spine Division Receives FDA Clearance for Serrato Pedicle Screw

Stryker Corp.’s Spine division today announced that its Serrato Pedicle Screw, intended for use in the non-cervical spine as part of the company’s Xia 3 Spinal System, has received 510(k) clearance from the U.S. Food and Drug Administration.
 
Serrato Pedicle Screws feature enhanced serrated cutting flutes, a unique dual-thread pattern with an increased number of leads for rapid insertion, and a patented buttress thread locking mechanism designed to minimize cross threading and splaying of the screw head.^1,2  The screws accommodate a variety of rod diameters and materials to suit the patient’s needs—5.5 and 6 mm diameter rods in commercially pure titanium, titanium alloy, and Vitallium.
 
“Pedicle screws have been used for decades with very few changes to their design,” said Bradley Paddock, president of Stryker’s Spine division. “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.”
 
Serrato leverages the broad portfolio of the Xia 3 Spinal System, an orthopaedic spinal system comprised of a variety of shapes and sizes of screws, blockers, and hooks that affix several different types of rods and connectors to vertebrae or the spinal column for purposes of stabilization, or corrective action through the application of force.
 
Intended Use
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.
 
Stryker is one of the world’s leading medical technology companies offering an array of products and services in orthopaedics, medical and surgical, and neurotechnology and spine. Stryker is active in more than 100 countries around the world.

References
1. Stryker Patent #6,074,391
2. Stryker Design History File DHF0000016688