3D-printed lateral cage becomes the first-ever 3D surgical solution with modular fixation capabilities
LEESBURG, Va., July 17, 2018 (GLOBE NEWSWIRE) -- K2M Group Holdings, Inc. (NASDAQ:KTWO) (the "Company" or "K2M"), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) and a CE Mark for its CAYMAN® United Plate System following completion of its first surgical cases. CAYMAN United is designed for rigid fixation to K2M’s CASCADIA™ Lateral 3D Interbody System featuring Lamellar 3D Titanium Technology™, the first and only 3D-printed cage with modular fixation capabilities. K2M was the first leading spine company to market a 3D-printed titanium interbody device and offers the most comprehensive portfolio of 3D-printed spinal devices on the market.
“The CAYMAN United Plate System, which firmly fixates to K2M’s CASCADIA Lateral 3D implants, is a notable advancement,” said Robert Lee, FRCS (Tr&Orth), a spine surgeon at Royal National Orthopaedic Hospital NHS Trust in Stanmore, UK. “Its streamlined technique and versatile insertion options provide an elegant solution for my minimally invasive lateral cases, while also utilizing a 3D-printed device to encourage bony integration throughout the implant.”
The CAYMAN United Plate System’s single level, 1- and 2- hole plate configurations precisely match all CASCADIA Lateral 3D height and lordosis options, allowing surgeons to customize the construct using a lateral approach. Single-level plate sizes minimize retraction required for placement and an assembly alignment feature keys into the CASCADIA implants to resist rotation. Versatile insertion options allow for plate assembly with a central assembly screw prior to implantation, or in-situ after the cage has been placed.
“We are excited to receive FDA clearance and a CE Mark for our CAYMAN United Plate System, designed to enhance our CASCADIA Lateral 3D Interbody System and making it the first and only 3D-printed cage available on the market with modular fixation capabilities,” said K2M Chairman, President, and CEO, Eric Major. “As a leading innovator of 3D-printed spinal solutions, we remain committed to developing advanced technologies that when complemented by our comprehensive Balance ACS platform, help surgeons facilitate 3D spinal balance in their patients.”
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.
Balance ACS® (or BACS®) provides surgical solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach of the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.
For more information on the CASCADIA Lateral 3D Interbody System featuring Lamellar 3D Titanium Technology and the CAYMAN United Plate System, visit www.K2M.com. For more information on Balance ACS, visit www.BACS.com.
K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative 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. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn and YouTube.
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Zeno Group on behalf of K2M Group Holdings, Inc.
Christian Emering, 212-299-8985
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500
Source: K2M Group Holdings, Inc.