LEESBURG, Va., Dec. 16, 2015 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (Nasdaq:KTWO) (the “Company” or “K2M”), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques, and minimally invasive procedures, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the EVEREST® Minimally Invasive (MI) XT Spinal System, the Company’s latest addition to the family of EVEREST products. In addition to U.S. regulatory clearance, K2M also received a CE Mark for the system, which allows the Company to expand the global availability of the product.
The EVEREST MI XT Spinal System is a cannulated top-loading pedicle screw system featuring rigid closed-top break-off extension tabs for minimally invasive rod passage. 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.
“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,” said Dr. 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 and includes several new designs for simplifying surgical application of the implants, including a simple extension tab removal technique. The screw head is compatible with all EVEREST system instrumentation post-tab removal. The EVEREST MI XT screw features the EVEREST platform technology providing 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 6.0 mm.*
“The EVEREST MI XT System exemplifies K2M’s commitment to advancing their Minimally Invasive Spine technology platform,” said Dr. 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. “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. K2M’s SERENGETI®Retractor and XT technology both create new avenues for addressing the complexities associated with minimally invasive spinal deformity correction procedures.”
“We are excited to receive U.S. regulatory clearance and a CE Mark for our EVEREST Minimally Invasive XT Spinal System, and are pleased with surgeon feedback following the completion of the first surgical cases in the U.S. and Australia,” stated Eric Major, K2M’s President and CEO. “Whereas our SERENGETI Minimally Invasive Retractor System offers a flexible design, the EVEREST MI XT System further strengthens our MIS portfolio by offering a rigid design and providing surgeons another innovative minimally invasive option.”
The EVEREST MI XT Spinal System is the fourth offering in the EVEREST family of products, which also includes the EVEREST Minimally Invasive Spinal System, the EVEREST Deformity Spinal System, and the EVEREST Degenerative Spinal System.
For more information on the EVEREST MI XT Spinal System and K2M’s complete product portfolio, visit www.K2M.com.
*Support data available upon request. Mechanical testing may not represent clinical results.
K2M Group Holdings, Inc. is a global medical device company focused on designing, developing and commercializing innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most difficult and challenging spinal pathologies. K2M has leveraged these core competencies to bring to market an increasing number of products for patients suffering from degenerative spinal conditions. These technologies and techniques, in combination with a robust product pipeline, enable the Company to favorably compete in the global spinal surgery market. Additional information is available online at www.K2M.com.