K2M receives FDA clearance to market new minimally invasive spine system
K2M Group Holdings Inc. recently announced it received 510(k) clearance from the FDA to market its Everest Minimally Invasive XT Spinal System.
The company also received a CE Mark for the system, which allows global sales of the product. “Whereas our Serengeti Minimally Invasive Retractor System offers a flexible design, the Everest MI XT System further strengthens our minimally invasive surgery portfolio by offering a rigid design and providing surgeons another innovative minimally invasive option,” Eric Major, K2M president and chief executive officer, said in a press release.
The minimally invasive surgical system provides surgeons with multiple insertion options and includes designs for simplifying surgical application of the implants, including an extension tab removal technique. The screw head is compatible with all Everest system instrumentation post-tab removal, according to the press release.
The system screw features the Everest platform technology, which provides 70° range of polyaxial motion and features a mixed-metal (Ti/CoCr) head, a dual-lead thread pattern, a set screw featuring a modified square thread design and the ability to accept rods in diameters of 5.5 mm and 6 mm.
This is the fourth system in the Everest portfolio.