FDA clears the Everest Degenerative spinal system

100

K2M announced at the International Society for the Advancement of Spine Surgery (SAS) Conference that it has received 510(k) clearance from the FDA to market the Everest Degenerative spinal system, a versatile top-loading polyaxial pedicle screw system featuring the ability to accommodate multiple levels of fixation rigidity to help surgeons individualise patient care.

The system provides for titanium and cobalt chrome rods of two different diameters, 5.5 and 6.0mm, limiting inventory and increasing adaptability.

 

Everest is designed to maximise both osteoporotic and dense bone fixation and the modified square thread of the locking set screw may reduce the potential for cross-threading. Additionally, the mixed material screw head minimises splay compared to a screw head made entirely of titanium, which improves the biomechanical performance of the construct.

“A combined team of surgeons and engineers worked closely together to design the Everest Degenerative spinal system, which utilises both titanium and cobalt chrome and optimises thread pitch for use in both osteoporotic and dense bone fixation,” said John Carbone, orthopaedic surgeon at Harborview Reconstructive Spine & Orthopedic Specialists, USA. “In my opinion, the strength, range of motion, and stiffness of Everest provide surgeons the intraoperative flexibility to address a variety of surgical pathologies.”