K2M received 510(k) clearance from the U.S. Food and Drug Administration to market the CAPRI Corpectomy Cage System, an expandable vertebral body replacement device.
The device is intended for use in the thoracolumbar spine — T1 to L5 — to replace collapsed, damaged or unstable vertebral bodies due to tumor or trauma. The system is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
"We are pleased to receive 510(k) clearance for the CAPRI Corpectomy Cage System, K2M's innovative and unique solution for stabilization of the spine that allows for intraoperative endplate manipulation," said Eric Major, K2M's president and CEO. "As the company continues to expand its presence in the complex spine market, this important milestone reinforces K2M's mission of developing differentiated technologies to improve the lives of patients."
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