October 24, 2017
ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced that it will commercially launch its Serrato™ pedicle screw, a unique dual-lead screw intended for use in the non-cervical spine, at the North American Spine Society (NASS) Annual Meeting, Oct. 25-28, 2017, Orlando, Fla. (booth No. 500).
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, MD, PhD, 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.
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. For the full Indications for Use, please refer to the Xia 3 Spinal System Instructions for Use.
About Stryker
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. Follow Stryker’s Spine division on Twitter @stryker_spine.
References
1. Serrato Claims Validation Report | DHF 0000052658
Dr. Vaccaro 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.
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Contacts
Sullivan & Associates
Barbara Sullivan, 714-374–6174
bsullivan@sullivanpr.com
