Belgium-based additive manufacturer and 3D printing company Materialise (NSDQ:MTLS) said the FDA sent it a “not substantially equivalent” letter for its X-ray knee guide system, dooming its bid for 510(k) clearance from the federal safety watchdog.
The Materialise system is designed to help align total knee replacement components without MRI or CT scans, the company said.
“We are disappointed that the FDA concluded that, based on the information submitted, our X-ray knee guide system cannot be considered as substantially equivalent to our solutions based on CT or MRI images. While this decision will impact the timing of the marketing of our innovative solution in the United States, we will continue to pursue the regulatory clearance process, taking into account the feedback from the FDA,” founder & CEO Wilfried Vancraen said in prepared remarks.
Materialise said its Mimics Innovation Suite was used to design the stent, constructed from a bioresorbable platform licensed to TRS from the University of Michigan in 2007. The splints have been given an FDA investigational device exemption to treat tracheobronchomalacia, the companies said at the time.