Stryker’s Serrato Pedicle Screws Implanted by More Than 100 Surgeons in First Month

Stryker’s Spine division said that Serrato Pedicle Screws have been implanted by more than 100 surgeons across the United States during the first 30 days since release, prior to full commercialization.
 
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, and True-tip geometry, which allows for precise insertion and immediate bone engagement. Stryker’s design innovations elevate one of the most basic spinal surgery tools, with the goal of reducing work, increasing speed, and enhancing surgeon efficiency.
 
“We are very excited by the initial response to Serrato from our early users,” said Bradley Paddock, president of Stryker’s Spine division. “The feedback from surgeons is exceeding expectations.”
 
“Game-changing screw,” said Roderick Sanden, M.D., an orthopedic surgeon with Advanced Neurospinal Care and Sutter Roseville Medical Center in Northern California. “I never thought a pedicle screw made that much of a difference until I put in a Serrato screw.”
 
The Serrato pedicle screw, intended for use in the non-cervical spine as part of the company’s Xia 3 Spinal System, received 510(k) clearance from the U.S. Food and Drug Administration in May. Serrato leverages the broad portfolio of the Xia 3 Spinal System, an orthopedic 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 purpose of stabilization. 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 Serrato screw insertion was exactly what I was hoping for,” said Scott Luhmann, M.D., head of surgery, Pediatric Orthopaedics at Shriners Hospital for Children in St. Louis. “It allowed for easy initiation of the screw, good tactile feedback, and excellent purchase!” Luhmann is a paid consultant of Stryker.
 
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 products and services in Orthopedics, Medical and Surgical, and Neurotechnology and Spine. The company is based in Kalamazoo, Mich.