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LEESBURG, Va.–(BUSINESS WIRE)–K2M, Inc., a spinal device company developing innovative solutions for the treatment of complex spinal pathologies, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ALEUTIAN^® Spacer Systems as intervertebral body fusion devices. The ALEUTIAN family of five different systems offers a full array of anatomically designed PEEK-OPTIMA^® interbody options, including the Anterior-Lumbar Interbody Fusion (ALIF), Small-Anterior (Cervical), Posterior-Lumbar Interbody Fusion (PLIF), Anatomically Narrow (AN), and Transforaminal-Lumbar Interbody Fusion (TLIF).

ALEUTIAN features radiolucent properties which have the potential to increase visualization of bone graft, while allowing for more accurate fusion assessment. In addition, the elastic modulus, a physical property of the material, more closely matches that of cortical bone for load sharing with the potential to minimize stress shielding and enhance fusion results. The bulleted nose allows for easier insertion and distraction, and the self-retaining teeth can potentially provide post-operative stabilization of the implant.

According to Dr. Raphael Roybal, Orthopedic Spine Surgeon at the Savannah Spine Institute, “The ALEUTIAN family of interbody PEEK cages provides a reproducible bridge where successful arthrodesis crosses over to superior anatomical reconstruction.”

“FDA clearance for the ALEUTIAN Spacer Systems to be marketed as intervertebral body fusion devices provides surgeons with multiple surgical applications in the cervical and lumbar spine for the treatment of Degenerative Disc Disease (DDD) and Spondylolisthesis, as well as more complex applications,” stated Eric Major, K2M’s President and CEO. “The anatomically designed implants and differentiated surgical instruments facilitate and streamline surgical applications. The ALEUTIAN family of products complements our comprehensive product portfolio of best-in-class systems for treating all types of complex spinal pathologies.”

LEESBURG, Va.–(BUSINESS WIRE)–K2M, Inc., a spinal device company developing innovative solutions for the treatment of complex spinal pathologies, today announced the launch of the CASPIAN^™ Spinal System. CASPIAN is an all-inclusive system for rigid posterior fixation addressing the high surgeon demand for treatment of complex cervico-thoracic spinal conditions.

This comprehensive system is the first to provide two completely different polyaxial screw options, Mini DENALI^® and Mini MESA^®, as well as Mini Hooks, Mini Connectors, and 3.5 mm Rods. The Mini DENALI screw is an evolution of a more traditional set screw designed implant featuring 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. The Mini MESA screw features K2M’s flagship Zero-Torque Technology^® which applies zero torsional loads, or twisting forces, to the spine when locking the system.

According to Dr. Juan S. Uribe, Co-Director of Spinal Neurosurgery at the University of South Florida, “The low profile feature is unlike any other posterior cervical system and offers a significant clinical advantage.” Co-Director of Spinal Neurosurgery at the University of South Florida, Dr. Fernando L. Vale, stated, “The low profile and Zero-Torque Technology features of Mini MESA are very beneficial in these applications. CASPIAN offers the versatility and benefits of both MESA and DENALI, providing the surgeon with unmatched intra-operative flexibility.”

“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 rollout of CASPIAN 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.”