September 26, 2017
ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced that Serrato™ Pedicle Screws have been implanted by more than 100 surgeons across the U.S. 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 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!”
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 2017. 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 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.
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.
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Dr. Luhmann is a paid consultant of Stryker. His statements represent his own opinions based on personal experience and are not necessarily those of Stryker. Individual experiences may vary. A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.
The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.
Sullivan & Associates
Barbara Sullivan, 714-374–6174