K2M’s MESA® Mini and DENALI® Mini Spinal Systems Receive Additional FDA Clearance for Posterior Cervical Spine Fixation
LEESBURG, Va., April 06, 2016 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (Nasdaq:KTWO), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine and minimally invasive spine technologies and techniques, today announced it 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,” stated 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 innovative instrument technology to facilitate more efficient intraoperative use of the systems.
Developed using K2M’s revolutionary MESA Technology, MESA Mini features low-profile, 90° 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° polyaxial range of motion cervical and thoracic pedicle screws that incorporate a low-volume design and offer off-axis height adjustment.
For more information on the MESA Mini Spinal System, the DENALI Mini Spinal System, and K2M’s complete product portfolio, visit www.K2M.com.
About K2M
K2M Group Holdings, Inc. is a global medical device company focused on designing, developing and commercializing innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most difficult and challenging spinal pathologies. K2M has leveraged these core competencies to bring to market an increasing number of products for patients suffering from degenerative spinal conditions. These technologies and techniques, in combination with a robust product pipeline, enable the Company to favorably compete in the global spinal surgery market. Additional information is available online at www.K2M.com.
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Media Contact:
Zeno Group on behalf of K2M Group Holdings, Inc.
Marcie Kohenak, 202-965-7811
Marcie.Kohenak@ZenoGroup.com
Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500
K2M@westwicke.com
