US FDA clears Stryker’s Serrato pedicle screw


Stryker’s Spine division has announced that its Serrato pedicle screw, intended for use in the non-cervical spine as part of the company’s Xia 3 spinal system, has received 510(k) clearance from the US Food and Drug Administration (FDA).

Serrato pedicle screws feature enhanced serrated cutting flutes—a dual-thread pattern with an increased number of leads for rapid insertion—and a patented buttress thread locking mechanism designed to minimise cross-threading and splaying of the screw head. The screws are designed to accommodate a variety of rod diameters and materials to suit the patient’s needs—5.5 and 6mm diameter rods in commercially pure titanium, titanium alloy, and Vitallium.

Stryker’s Xia 3 is an orthopaedic spine 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 stabilisation, or corrective action through the application of force.

Xia 3 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, it is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of certain acute and chronic instabilities or deformities.


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