K2M MI System Gains CE Mark and FDA Clearance

K2M Group Holdings, Inc. announced on December 16, 2015 it has received FDA clearance and CE Mark to market the Everest Minimally Invasive XT Spinal System, the company’s newest addition to its Everest family of products.

The system is a cannulated top-loading pedicle screw system featuring rigid closed-top break-off extension tabs for minimally invasive rod passage. According to the company, the system’s implant design “offers a one-step true percutaneous delivery of the screw and built-in extension, which does not require intraoperative assembly. The closed-top design provides a rigid connection for in-situ rotation of the screw heads and internal threads of the extension tabs allow for rod reduction.”

Andrew Kam, M.D., director of spinal trauma at Westmead Hospital in Sydney, Australia, said the screw’s mixed-metal design “allows for a slim profile while maintaining a robust tab-to-screw connection.” He added that some other minimally invasive systems can fail to secure the set screw properly when compression is applied. The XT system “aims to address this by allowing free movement of the polyaxial heads under and compression and during set screw locking.”

According to the company announcement, the system’s streamlined instrumentation “provides surgeons with multiple insertion options in one system and includes several new designs for simplifying surgical application of the implants, including a simple extension tab removal technique.” In addition, the screw head is compatible with all Everest system instrumentation post-tab removal. The XT screw provides a 70° range of polyaxial motion and features a mixed-metal (Ti/CoCr) head, “to minimize 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, M.D., 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, said 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.”

The XT system is the fourth offering in the Everest family of products, which also includes a minimally invasive, a deformity and degenerative spinal system.