K2M Wins FDA 510(k) Clearance, CE Mark for Everest Spinal System
Spinal technology provider K2M has scored 510(k) clearance and CE marking for its Everest Minimally Invasive XT Spinal System.
The cannulated top-loading pedicle screw system features rigid closed-top break-off extension tabs for minimally invasive rod passage.
Andrew Kam, the director of spinal trauma at Westmead Hospital in Sydney, Australia, says the system addresses limitations of current minimally invasive systems by allowing free movement of the polyaxial heads under compression and during set screw locking.
Some systems can fail to secure the set screws properly when compression is applied to the pedicle screws with inadequately tightened set screws, Kam says. — Michael Cipriano