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Legal & Regulatory Feature

Xia Spinal System / Courtesy of Stryker Spine

Stryker Pedicle Screw Cleared by FDA

Walter Eisner • Thu, August 17th, 2017

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On August 16, 2017, the company announced the screw, used in the non-cervical spine, received 510(k) Clearance from the agency.

The company says the screw features 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. 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.

Walking the fine line between receiving clearance for something "substantially equivalent" to a previously approved device and something groundbreaking requiring full FDA approval, Brad Paddock, the spine division president, said, “Pedicle screws have been used for decades with very few changes to their design. 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.”

The screw is part of the company's Xia 3 Spinal System. The system is 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 purposes of stabilization, or corrective action through the application of force.

The company said the system was developed with the aim to develop better implants and is represented by the patented buttress thread closure mechanism. “What started as a top-loading pedicle screw system for treatment of degenerative spine pathologies has grown to include deformity solutions and a recently introduced trauma/tumor line extension.”

“The Xia Spinal System is comprised of implants and instruments for stabilization of the spine during fusion in the thoracic, lumbar and sacral regions, with many features including:

  • Reduced profile and implant volume
  • Patented buttress thread closure mechanism
  • Ergonomically designed instruments
  • Available in stainless steel and titanium alloy”

According to the company, the intended use of the system is for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the 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.

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