Materialise announced that the company is in receipt of a not substantially equivalent (NSE) letter from the U.S. Food and Drug Administration (FDA) regarding the 510(k) submission for its innovative X-ray knee guide system.
The system is intended to be used as a surgical instrument to assist in the positioning of total knee replacement components, without MRI or CT.
Materialise NV offers health care professionals a full range of 3D surgical planning solutions, including personalized knee replacement solutions based on CT or MRI images, which are cleared by the FDA.
Wilfried Vancraen, Founder and CEO of Materialise states, "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."
With its headquarters in Leuven, Belgium, and branches worldwide, Materialise is a provider of Additive Manufacturing (AM) software solutions and sophisticated 3D printing services in a wide variety of industries, including healthcare, automotive, aerospace, art and design and consumer products.
Materialise has been playing an active role in the field of AM since 1990, through its involvement in AM for industrial and medical applications, by providing biomedical and clinical solutions such as medical image processing and surgical simulations and by developing unique solutions for its customers’ prototyping, production, and medical needs.