FDA Clears K2M’s OZARK Cervical Plate Systems

K2M Group Holdings Inc., a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance, today surpassed its 100th product milestone with the announcement of U.S. Food and Drug Administration (FDA) 510(k) clearance and commercial launch of its OZARK Cervical Plate Systems—designed for anterior screw fixation to the cervical spine (C2-T1) in patients with degenerative disease, deformity, tumor, or trauma.
 
“K2M is excited to celebrate our 100th product milestone following regulatory clearance for the OZARK Cervical Plate Systems, the latest in our growing portfolio of cervical solutions designed to facilitate 3D spinal balance in patients,” said K2M Chief Medical Officer and Co-founder John P. Kostuik, M.D. “At K2M, excellence in innovation is at the heart of all that we do. Since our founding we’ve focused on developing groundbreaking solutions for patients with spinal disease and remain dedicated to furthering this legacy.”
 
The OZARK Cervical Plate Systems are available in two designs, OZARK Guide and OZARK View, both featuring an advanced per-level, integrated locking cover that provides surgeons with clear visual and tactile confirmation of the final lock position. They both include a full range of plate and screw sizes and instrumentation for creating constrained, semi-constrained or hybrid screw constructs. The systems are compatible with K2M’s CASCADIA Cervical 3D Interbody Systems featuring Lamellar 3D Titanium Technology, which uses an advanced 3D printing method to create structures that are impossible with traditional manufacturing techniques.
 
“K2M was founded on the idea of inventing the world’s most advanced technology for treating spinal deformity,” said K2M Chairman, President, and CEO Eric Major. “Today, we are proud to further realize this vision through our 100th product milestone in the OZARK Cervical Plate Systems. We remain committed to continue building out our product portfolio, that when supported by our Balance ACS Platform, helps surgeons address important surgical needs to improve the lives of spinal deformity patients worldwide.” 
 
Balance ACS or (BACS) is a comprehensive platform applying three-dimensional solutions across the entire clinical care continuum to help drive quality outcomes in spine patients. BACS provides solutions to help surgeons achieve balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach to the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.   
 
K2M Group Holdings Inc. designs, develops, and commercializes complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. The company is based in Leesburg, Va.