K2M Addresses High Demand for Treating Complex Cervico-Thoracic Pathologies; CASPIAN Spinal System Receives 510(k) and CE Mark Clearance

LEESBURG, Va.--(BUSINESS WIRE)--K2M, Inc., a spinal device company developing innovative solutions for the treatment of complex spinal pathologies, today announced the introduction of an all-inclusive solution for rigid posterior fixation of the cervico-thoracic regions of the spine. The CASPIAN™ Spinal System has received FDA 510(k) and CE Mark clearance for domestic and international distribution, expanding the global presence of K2M technologies.

This comprehensive system provides two different polyaxial screw options, Mini MESA™ and Mini DENALI™, as well as Mini Hooks and 3.5 mm Rods. The Mini MESA screws feature K2M’s flagship Zero-Torque Technology™ which applies zero torsional loads, or twisting forces, to the spine when locking the system. The Mini DENALI screws feature off-axis screw height adjustment, whereby the screwdriver does not need to be co-linear with the screw shaft to adjust the screw during surgery.

According to Dr. Pierce Nunley, Director of the Spine Institute of Louisiana, “The Zero-Torque locking mechanism and ability to do complex manipulations easily on individual screws across multi-level constructs is superior to any other posterior cervico-thoracic reconstruction system on the market.”

“The CASPIAN Spinal System is an important introduction for K2M, because it addresses the increasing demand from the surgeon community to offer our innovative MESA Zero-Torque Technology for the upper regions of the spine,” stated Eric Major, K2M’s President and CEO. “The CASPIAN clearance moves us one step closer to our goal of providing a complete product portfolio of best-in-class systems for treating all types of complex spine pathologies.”

K2M, Inc. is an innovative spinal device company that develops simplified solutions for the treatment of complex spinal pathologies and procedures. Chief Medical Officer, Chairman and co-founder, Dr. John Kostuik, former Chief of Spine Surgery at The Johns Hopkins University School of Medicine, drives K2M’s commitment to redefining the market. K2M’s comprehensive line of products include: spinal stabilization systems, minimally invasive systems, and other advancements in spine solutions for Degenerative Disc Disease (DDD), as well as deformity, trauma, and tumor. Additional information is available online at www.K2M.com.

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