K2M’s Spinal Disease Device Receives 510(k) Clearance

K2M Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Everest Degenerative Spinal System, a top-loading polyaxial pedicle screw system that can accommodate multiple levels of fixation rigidity to help surgeons individualize patient care. The announcement was made at the International Society for the Advancement of Spine Surgery Conference in Las Vegas, Nev.

The Everest features a locking set screw with a modified square thread, which could reduce the potential of cross-threading. In addition, the mixed material screw head minimizes splay in comparison to the titanium screw head, which improves biomechanical performance.

“In my opinion, the strength, range of motion, and stiffness of Everest provides surgeons the intraoperative flexibility to address a variety of surgical pathologies,” said John Carbone, M.D., orthopedic surgeon at Harborview Reconstructive Spine and Orthopedic Specialists in Maryland.

K2M President and CEO Eric Major called the FDA clearance for Everest an important expansion of his company’s product offering for treatment of degenerative disc disease and other complex pathologies.

K2M is a spinal device manufacturer headquartered in Leesburg, Va.