K2M receives US FDA 510(k) clearance for Everest MI XT spinal system

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K2M has received 510(k) clearance to market the Everest minimally invasive (MI) XT spinal system from the US Food and Drug Administration (FDA). K2M has also received CE mark for the system.

The Everest MI XT spinal system is a cannulated top-loading pedicle screw system featuring rigid closed-top break-off extension tabs, designed for minimally invasive rod passage. The system’s implant design is intended to offer a one-step true percutaneous delivery of the screw and built-in extension, which does not require intraoperative assembly. The closed-top design is designed to provide a rigid connection for in-situ rotation of the screw heads and internal threads of the extension tabs should allow for rod reduction.

“The Everest MI XT spinal system has been developed to simplify minimally invasive spinal surgery for a wide range of clinical applications. The XT screw’s mixed-metal design allows for a slim profile while maintaining a robust tab-to-screw connection,” says Andrew Kam, director of Spinal Trauma at Westmead Hospital in Sydney, Australia. “The Everest MI XT instrumentation was designed to address the limitations of some minimally invasive systems. For example, some systems can fail to secure the set screws properly when compression is applied to the pedicle screws due to inadequately tightened set screws under load. The new Everest MI XT Kampressor aims to address this by allowing free movement of the polyaxial heads under compression and during set screw locking.”

The system’s streamlined instrumentation provides surgeons with multiple insertion options in one system, according to K2M, and includes several new designs for simplifying surgical application of the implants, including a simple extension tab removal technique. The Everest MI XT screw features the Everest platform technology, designed to provide a 70° range of polyaxial motion and features a mixed-metal (Ti/CoCr) head designed to minimise head splay (when compared to an all-titanium screw), a dual-lead thread pattern for faster insertion and increased pullout strength, a set screw featuring a modified square thread design to facilitate set screw introduction, and the ability to accept rods in diameters of 5.5 and 6.0mm.

Kornelis Poelstra, chairman of the Department of Surgery at Sacred Heart Hospital on the Emerald Coast in Destin, Florida, and co-chairman of the Global Forum for the Society for Minimally Invasive Spinal Surgery, says, “With the addition of the XT system, the Everest MI platform becomes one of the most comprehensive minimally invasive screw systems on the market, offering both rigid extensions and flexible retractors that can be used with the same screw system.”

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