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Product received FDA 510(k) clearance in September.
March 14, 2018
By: K2M Group Holdings Inc.
K2M Group Holdings Inc., a global developer of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance, commercially launched the YUKON OCT Spinal System. The YUKON OCT Spinal System, which received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) in September 2017, was developed to help surgeons restore cervical sagittal balance through posterior fixation in the occipito-cervico-thoracic regions of the spine. It features a newly designed top-loading polyaxial screw with high angulation and the ability to accommodate rods in two diameters. The screw provides 60 degrees of angulation for 60 degrees of coronal swing “60 for 60” to aid in screw placement, providing up to 105 degrees of polyaxial angulation. “We are pleased to launch our next-generation YUKON OCT Spinal System, an important addition to our growing complex spine portfolio,” K2M Chairman, President, and CEO Eric Major said. “K2M is committed to restoring alignment in an era of global change, as evidenced by this latest commercial milestone and through our comprehensive Balance ACS platform.” YUKON OCT screw heads accept both Ø3.5 & Ø4.0 mm rods in both cobalt chrome and titanium to accommodate construct rigidity based on degenerative or deformity corrections. The system’s streamlined reduction instruments allow for intraoperative flexibility and ease of use. A Pistol Grip Rod Reducer provides up to 20 mm of reduction, while the Sequential Reducers deliver up to 15 mm of controlled reduction and correction. 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. 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.
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