3D software developer Materialise has received a not substantially equivalent (NSE) letter from the U.S. Food and Drug Administration (FDA) in response to a 510(k) submission for its x-ray knee guide system.
While disappointed that the FDA has concluded that the x-ray knee guide system cannot be considered as substantially equivalent to its offerings based on CT or MR images, Materialise founder and CEO Wilfried Vancraen said in a statement that the company will continue to pursue the regulatory clearance process, taking into account the FDA feedback.
The x-ray knee guide system is designed for use as a surgical instrument to aid in positioning total knee replacement components without the use of MRI or CT, according to the vendor.
