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FDA approves Stryker’s Serrato pedicle screw for use in non-cervical spine

MDBR Staff Writer Published 17 August 2017

Stryker has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Serrato pedicle screw for use in the non-cervical spine, which is part of the firm’s Xia 3 spinal system.

Serrato pedicle screws include enhanced serrated cutting flutes, which feature dual-thread pattern with an increased number of leads for rapid insertion.

They will also feature patented buttress thread locking mechanism that will enable to minimize cross threading and splaying of the screw head.

Screws provide flexibility to be used with a variety of rod diameters and materials to suit the patient’s needs.

They can be used with 5.5mm and 6.0mm diameter rods, which are available in pure titanium, titanium alloy and Vitallium forms.

Serrato is said to leverage the wide portfolio of the Xia 3 spinal system, which is an orthopaedic spinal system that includes different shapes and sizes of screws, blockers, and hooks.

They are developed to be used for affixing various different types of rods and connectors to vertebrae or the spinal column for purposes of stabilization or corrective action through the application of force.

When used as an anterior or anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, Xia 3 spinal system will offer additional support during fusion using autograft or allograft in skeletally mature patients to treat various acute and chronic instabilities or deformities.

Stryker’s spine division president Bradley Paddock 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.”


Image: The FDA campus in New Hampshire Ave, Silver Spring, Maryland. Photo: courtesy of The U.S. Food and Drug Administration.