Mecuris, the Munich-based prosthesis manufacturer, recently shipped and delivered its first certified 3D prosthetic feet named NexStep.
The “CE” marking (European Conformity) on the prosthesis confirms that it meets the technical standards required by the European legislation. It also means that a free flow of the prosthesis is now possible in the European Union and/or the 3 member states of the European Free Trade Association (EFTA).
NexStep is at this moment one of the first free 3D printed foot prostheses available on the market.
Good news: this orthopaedic help can be customized in a few minutes using Mecuris Cloud’s digital platform. The cloud-based solution is currently in a beta phase. A wide range of health professionals are testing and providing feedback on this prosthesis.
The certification process
In order to obtain the CE certification, a variety of tests including a mechanical durability and load-resistance tests, were undertaken. All these tests were carried out in less than 4 months.
The prosthetic foot proved its strength and resilience by enduring a peak load up to 8000 N. An ultimate test on a patient who wore the prosthesis during a 3 years period was a success.
According to Carolin Taubmann, Quality Management and Simulation at Mecuris, they passed these tests with flying colours thanks to their simulation activities with a 3D foot model.
Thanks to this CE certification, Mecuris took one step forward in the manufacturing of high-quality prostheses printed in 3D.
NexStep used by a patient
Jannis Breuninger, Mecuris Product Manager, explains in an interview the impact NexStep prosthesis might have:
[We digitally designed two NexStep prostheses for a patient. The resulting CAD models were 3D printed in a certified printing centre in Germany. After a last inspection, they were sent to a health care professional in Eastern Europe, who treated the patient. The latter was quite glad to receive his prosthesis very earlier. He used to wait for 2 to 3 months before receiving it. The long-term goal of the company is to deliver prostheses in 48 hours.]
What’s next?
The German start-up will present its innovative NexStep prosthesis during the ISPO World Congress in Cape Town, South Africa between May 8th and 11th. Two runners will test the prosthetic feet printed in 3D. Mecuris also announced that its digital cloud-based customization platform and other surprises will be unveiled during the event. So stay tuned!
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