FDA clearance for K2M’s CAPRI corpectomy cage system


K2M has received Food and Drug Administration (FDA) 510(k) clearance to market the CAPRI corpectomy cage system, an expandable vertebral body replacement device that provides structural stability following a corpectomy or vertebrectomy. The device is currently being previewed at the North American Spine Society (NASS) 2014 Annual Meeting in San Francisco, USA.

The CAPRI system is intended for use in the thoracolumbar spine (T1 to L5) to replace collapsed, damaged or unstable vertebral bodies due to tumour 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, 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.”