Medical device company K2M Group Holdings has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its MESA 2 Deformity Spinal System.
The pedicle screw system has been developed to address the complex spinal pathologies, noted K2M.
The system features MESA 2 screw that offer a dual-lead thread pattern for fast insertion and Zero-Torque Technology, which provides surgeons the ability to one-step lock without torsional stress being applied to the spine.
MESA 2 Deformity Spinal System features both polyaxial and uniplanar screws.
K2M Group Holdings president and CEO Eric Major said: "The development of MESA 2 reflects K2M’s continued commitment to developing innovative products and providing surgeons with tools that facilitate their management of the most challenging spinal conditions.
"MESA 2 carries forward the hallmarks of our MESA and Cricket rod reduction technologies, while offering new capabilities with the goal of enhancing user experience."
K2M is involved in developing complex spine and minimally invasive spine technologies and techniques to treat challenging spinal pathologies.