Two K2M Spine Devices Get Additional Clearances from FDA

Leesburg, Va.-based K2M Group Holdings Inc., a medical device company that makes proprietary complex spine and minimally invasive spine technologies and techniques, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded indications of its Mesa Mini spinal system and Denali mini spinal system.

The Mesa Mini and Denali Mini spinal systems function as adjuncts to fusion, providing stabilization of the posterior cervical and thoracic spine. Both systems were previously cleared for use in the posterior thoracic spine, from T1-T3. The new clearance now allows for the systems to be used in the posterior cervical spine, from C1-C7, in addition to the thoracic spine.

“With this FDA clearance, we are excited to provide surgeons treating the cervico-thoracic regions of the spine with expanded use of our Mesa Mini and Denali Mini Spinal Systems,” said Eric Major, K2M’s president and CEO. “This new clearance reinforces the clinical effectiveness of posterior cervical screws, differentiates K2M from our competitors in the complex spine cervical markets that currently lack this important regulatory indication, and clears the path for our future development of innovative technologies to treat spinal conditions in the posterior cervical spine.”

The Mesa Mini and the Denali Mini spinal systems are comprehensive, 3.5 mm diameter rod systems that offer all-inclusive answers for rigid posterior fixation of the cervico-thoracic regions of the spine. The systems feature multiple hook and rod options, and instrument technology designed to facilitate more efficient intraoperative use of the systems.

Developed using K2M’s Mesa technology, Mesa Mini features low-profile, 90 degree range of motion cervical and thoracic screws and zero-torque technology, which offers surgeons the ability to one-step lock without applying torsional stress to the spine. The Denali Mini implants feature top-loading, 50 degree polyaxial range of motion cervical and thoracic pedicle screws that incorporate a low-volume design and offer off-axis height adjustment.