Materialise: Innovative X-Ray Knee Guide System Rejected By FDA

When following new innovations in the medical and healthcare industries, it often may not be apparent immediately, but if you dig deeply enough you will find involvement from Materialise in the majority of 3D printed devices, models, and implants being made for the healthcare system. The Belgium-based company is also often first on the list to be called when serious circumstances are at hand as well. This has been demonstrated repeatedly, most especially in cases like those of 3D printed models helping for the diagnosis and treatment of tumors, or 3D printed guides assisting in hip replacement surgeries.

From supplying Airbus with 3D printed parts for their planes to offering supportive 3D printing Magics²⁰ software for architects, one could easily surmise that there’s rarely a quiet day at the office for the Materialise team. With one valuable innovation after another, they are certainly on top of their game as a leader in addivitive manufacturing developments. As they state, “We are Materialise and we are all around you, making the world a better and healthier place to live in.”

But you simply can’t win them all, and it looks as if the Materialise team may be going back to the drawing board regarding their latest design for a knee replacement guide. They have just announced receipt of a ‘not substantially equivalent’ letter from the FDA. This comes on the heels of their submission for an innovative X-ray knee guide system, which now seems to have a questionable future, as it stands. Materialise states that this 3D guide is meant for use as a surgical instrument which would help surgeons in the operating room while putting knee replacement components into place. This particular X-ray device allows for the positioning without an MRI or CT.

“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,” said Wilfried Vancraen, Founder and CEO of Materialise. “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.”

Taking the try and try again approach, obviously Materialise is not giving up on the knee replacement guide. With the FDA issue being just a bump in the road, it’s to be expected that the company will have whatever issues are present with the design fixed expediently.

With its main branch in Leuven, Belgium, Materialise is a worldwide presence regarding complex 3D printing innovations and services. They are the very definition of versatile, offering products for a wide and varying range of industries, from healthcare to automotive. Creating products through 3D printing since 1990, Materialise continues to be the leader in numerous solutions–especially that of biomedical and clinical devices.  Discuss this story in the Materialise Knee Guide forum on 3DPB.com.