New occipito-cervico-thoracic fusion system features an advanced polyaxial screw for degenerative & complex spinal pathologies
Leesburg, VA (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) for its YUKON™ OCT Spinal System. YUKON OCT offers surgeons an advanced system aimed at facilitating fusion with posterior fixation in the occipito-cervico-thoracic regions of the spine with the goal of helping to achieve three-dimensional spinal balance.
The YUKON OCT Spinal System features newly designed top-loading, high angulation, polyaxial screws that provide up to 105 degrees of polyaxial angulation. YUKON OCT screw heads accept both Ø3.5 & Ø4.0 mm rods in both cobalt chrome and titanium, and accommodate construct rigidity based on degenerative or deformity corrections. Square thread set screws facilitate screw introduction and minimize the potential for cross-threading, while an updated occipital plate features integrated lateral holes with the goal of enhancing occiput fixation.
“The YUKON OCT System expands on K2M’s current offering while accounting for the challenging posterior cervical cases surgeons often treat,” said Chambliss Harrod, MD, a spine and orthopedic surgeon at the Bone & Joint Clinic of Baton Rouge. “Unlike systems that feature only highly favored angulation screw designs, YUKON OCT is a comprehensive system that offers surgeons the ability to treat a variety of spinal conditions—including routine degenerative cases, revisions, and complex cervical deformities.”
YUKON OCT’s advanced, streamlined reduction instrumentation allows for intraoperative flexibility and ease of use. The pistol grip style Rod Reducer provides 20 mm of reduction, while the Sequential Reducers deliver 20 mm of controlled reduction and correction.
“We are pleased to announce FDA clearance of the YUKON OCT Spinal System and the successful completion of its first surgical cases,” said K2M President and CEO Eric Major. “K2M is a global leader in spinal innovation and YUKON OCT is our new solution that deepens our expanding portfolio of spinal devices for the occipito-cervico-thoracic region of the spine. Accompanied by our comprehensive Balance ACS™ platform, YUKON OCT offers a competitive surgical solution with the goal of achieving Total Body Balance for patients.”
Balance ACS (BACS™) provides solutions focused on achieving 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.
For more information on the YUKON OCT Spinal System and K2M’s complete product portfolio, 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.
This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance. Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects. In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. 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SOURCE: K2M Group Holdings, Inc.