510(k) for CAPRI Corpectomy Cage System

Leesburg, Virginia – K2M Group Holdings Inc. officials announced the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the CAPRI Corpectomy Cage System, an expandable vertebral body replacement device that provides structural stability following a corpectomy or vertebrectomy.

“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,” stated 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.”

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 CAPRI Corpectomy Cage System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

CAPRI cages, manufactured 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.

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

Source: K2M