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K2M receives FDA 510(k) clearance for occipito-cervico-thoracic spinal system
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K2M announced it has received FDA 510(k) clearance for the Yukon OCT spinal system.
According to a company press release, the spinal system facilitates fusion with posterior fixation in the occipito-cervico-thoracic regions of the spine to help achieve 3-D spinal balance. The Yukon OCT features polyaxial screws that offer up to 105° of polyaxial angulation. Screw introduction is made easy with square, thread set screws and that reduce the chance of cross-threading. Updated occipital plates with integrated lateral holes reportedly enhance occiput fixation. According to the release, the streamlined instrumentation offers intraoperative flexibility and is easy for surgeons to use.
“We are pleased to announce FDA clearance of the Yukon OCT Spinal System and the successful completion of its first surgical cases,” Eric Major, K2M president and chief executive officer, said in the release. “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.”
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