K2M Group Holdings, a medical spine device company, received FDA clearance to market its EVEREST Minimally Invasive XT Spinal System. The company's new system also received a CE Mark.
Here are five key notes:
1. The EVEREST MI XT Spinal System is a cannulated top-loading pedicle screw system.
2. The design provides a one-step percutaneous delivery of the screw and built-in extension. It offers a rigid connection for in-situ rotation of the screw heads.
3. The system provides surgeons various insertion options, and is compatible with all EVEREST system instrumentation post-tab removal.
4. Addressing limitations of other minimally invasive systems, the EVEREST MI XT system provides a robust tab-to-screw connection.
5. This EVEREST system is the fourth in the EVEREST series, joining EVEREST Minimally Invasive Spinal System, EVEREST Deformity Spinal System and EVEREST Degenerative Spinal System.
"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," said Kornelis Poelstra, MD, chairman of the department of surgery at Sacred Heart Hospital on the Emerald Coast in Destin, Fla.