With FDA 510(k) clearance for CASCADIA Lateral line extension, K2M solidifies position as the global market-leading innovator and provider of 3D-printed spinal devices
LEESBURG, Va., Oct. 06, 2016 (GLOBE NEWSWIRE) -- K2M Group Holdings, Inc. (NASDAQ:KTWO) (the "Company" or "K2M"), 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) to expand its CASCADIA™ Lateral Interbody System featuring Lamellar 3D Titanium Technology™, the Company’s innovative technology that uses 3D printing with the goal of allowing for bony integration throughout an implant. The CASCADIA Lateral Interbody System line extension clearance strengthens K2M’s minimally invasive surgery (MIS) portfolio and the Company’s leadership in the 3D printing of spinal devices, as evidenced by its having the most comprehensive 3D-printed spinal portfolio available on the market.
|Lamellar 3D Titanium (Video Link)|
"CASCADIA is an exciting innovation for lateral spine fusions,” stated Greg T. Poulter, MD, an orthopedic spine surgeon at OrthoIndy. “The unique engineering and 3D printing allows the implant to have the biocompatibility and ongrowth characteristics of titanium, while allowing a stiffness that more closely matches bone. The graft volume and surface area for fusion are generous and the new size options for lordosis allow me to address each patient's individual sagittal plane requirements. CASCADIA has become my go-to implant for lateral interbody fusions."
K2M’s Lamellar 3D Titanium Technology uses an advanced 3D printing method to create structures that are impossible with traditional manufacturing techniques. Starting with a titanium powder, the CASCADIA implants are grown through the selective application of a high-energy laser beam, incorporating complex internal geometries and rough surface architecture that pre-clinical data have associated with bone growth activity.
Lamellar 3D Titanium Technology incorporates a porous structure along with rough surfaces to allow the potential for bony integration throughout the implant. K2M’s CASCADIA interbodies utilize this technology to create a 70% porous implant with an increased bone graft volume and similar stiffness when compared to K2M PEEK designs.
The CASCADIA Lateral Interbody System is part of the Company’s MIS portfolio, designed to promote less invasive access to the spine. The system functions as an invertebral body fusion device to provide support and stabilization of the lumbar segments of the spine. Its reverse hourglass implant design promotes increased endplate contact—compared to an ALEUTIAN® PEEK implant—without sacrificing internal bone graft volume. The system includes a full range of implant sizes and heights that are carefully designed to accommodate vertebral anatomy, and it is intended to work in conjunction with theRAVINE® Lateral Access System to offer a full line of instrumentation for the far lateral transpsoas approach.
“K2M is proud to strengthen our industry-leading portfolio of FDA-cleared, 3D-printed spinal solutions, thus reinforcing our market leadership and competitive advantage in this space,” stated K2M President and CEO Eric Major. “MIS procedures and 3D printing are core competencies for K2M, as indicated by the breadth and depth of our product offerings. We continue to be committed to our legacy of innovating the highest quality products with the ultimate goal of creating improved treatments for surgical patients around the globe who suffer from debilitating complex spinal deformities.”
The complete CASCADIA portfolio also includes the CASCADIA TL, AN, AN Lordotic Oblique, andCervical Interbody Systems. For more information on Lamellar 3D Titanium Technology, CASCADIA Interbody Systems, and K2M’s complete product portfolio, visit www.K2M.com
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.Christian Emering, 212-299-8985Investor Contact:Mike Piccinino, CFA, 443-213-0500Westwicke Partners on behalf of K2M Group Holdings, Inc.Published at Nasdaq GlobeNewswire