K2M Receives Clearance for Expandable Vertebral Body Replacement Device

Leesburg, Va.-based K2M Group Holdings Inc. has received 510(k) U.S. Food and Drug Administration clearance for its Capri corpectomy cage system, an expandable vertebral body replacement device designed to give structural stability following a corpectomy or vertebrectomy. President and CEO Eric Major said that is also allows for intraoperative endplate manipulation.

The Capri corpectomy cage system is intended for use in the thoracolumbar spine (T1 to L5) to replace collapsed, damaged or unstable vertebral bodies due to tumor or trauma (i.e., fracture). The system is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Capri cages, made from titanium and cobalt chrome, are offered in a variety of interchangeable footprint options, allowing for in-situ height expansion and endplate angulation to match the patient’s anatomy. Additionally, the device may be implanted through an anterior, lateral or posterior approach, the company reports.

“The continuous variability of endplate angulation and height expansion is designed to reduce the time it takes to place the corpectomy cages,” said Michael Finn, M.D., a neurosurgeon and assistant professor in the department of neurosurgery at the University of Colorado.