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CAPRI Corpectomy Cage System receives FDA 510(k) clearance

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SAN FRANCISCO — K2M announced here that its CAPRI Corpectomy Cage System, an expandable vertebral body replacement device for use following a corpectomy or vertebrectomy, has received U.S. Food and Drug Administration 510(k) clearance.

Intended to replace collapsed, damaged or unstable vertebral bodies due to tumor or trauma in the thoracolumbar spine (T1 to L5), the CAPRI Corpectomy Cage System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period, according to a K2M press release issued during the North American Spine Society Annual Meeting.

CAPRI cages are manufactured from titanium and cobalt chrome and are offered in a variety of interchangeable footprint options, allowing for in situ height expansion and endplate angulation to match the patient’s anatomy, according to the release. Implantation can be performed through an anterior, lateral or posterior approach.

“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,” Eric Major, K2M’s president and CEO, said in the release.

Reference: www.k2m.com.