Mar 28, 2017 | By Tess

Mecuris, a Munich-based manufacturer of bespoke 3D printed prosthetics, recently announced that it has shipped and delivered the world’s first CE-certified 3D printed prosthetic feet. The prosthetic in question, called “NexStep,” has been in development for some time, and with the CE mark (an important European medical certification), it is now ready for market.

Mecuris’ NexStep prosthetic (as well as its FirStep, for children) is one of the first 3D printed foot prosthetic available freely on the market. Importantly, the innovative orthopaedic aid can be customized to the patient in a matter of minutes using Mecuris’ cloud-based digital design platform. The cloud-based solution is currently in its beta stage, as a number of medical professionals are in the process of testing and providing feedback for it.

Having achieved CE certification for its 3D printed foot prosthetic, Mecuris is one (big) step closer towards making high-quality, tailored 3D printed prosthetics more accessible and more efficient. Jannis Breuninger, Mecuris head of product development, explains what the impact of the NexStep prosthetic could be:

“We digitally tailored two NexSteps to a patient only a week ago. The resulting CAD models were then 3D printed in a certified printing hub in Germany and delivered to us for final inspection. The feet will now be sent to a medical professional practicing in Eastern Europe. He will treat a young and active double-amputee with two NexStep provided by Mecuris. The patient was surprised that we already deliver, as he usually has to wait two to three months for an individual prosthesis. Our long-term goal is to ship custom prosthetics within 48 hours days.”

To obtain CE certification, the 3D printed NexStep prosthetic had to undergo a number of tests, which included a mechanical long-term durability test, load enduring tests, and more. In the end, the prosthetic foot demonstrated its strength and resilience, enduring a toe load of up to 8,000 N, and passing a test that simulated a patient wearing the prosthetic for over three years and then jumping down a number of stairs. “We passed these tests at the first go, thanks to our extensive computer simulation activities with a 3D model of the foot,” explained Carolin Taubmann, Quality Management & Simulation at Mecuris.

Impressively, the NexStep prosthetic foot managed to pass its CE certification tests in under four months, a feat which shows the potential and promise of the 3D printed aid. According to Mecuris CEO Manuel Opitz, his company is the first manufacturer in the world to achieve CE certification for a 3D printed prosthetic foot. “I have not heard yet of any other company having achieved CE-certification of an individual prosthetic foot. We will therefore leverage our advantage with further products, co-developed with experienced professionals from the industry,” he said.

The German startup will be showcasing its innovative NexStep prosthetic at the ISPO World Congress in Cape Town, South Africa between May 8 and 11. There, two runners will test the 3D printed prosthetic feet. Mecuris has also said its cloud-based digital tailoring platform, and other surprises will be unveiled at the event.

Currently, the Munich-based company is working on certifying a water-proof version of its NexStep prosthetic, which was initiated thanks to popular demand. Mecuris is hopeful that it will achieve the certification within a few months.



Posted in 3D Printing Application



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