Reimbursement of the Bodycad personalized unicompartmental knee system is approved by RIZIV/INAMI in Belgium. Hereby, Bodycad is the very first custom knee system reimbursed by the government on the Belgian market and now also commercially available as a very valuable alternative next to any standard uni knee on the Belgian market.
First personalized restoration procedures using Bodycad's personalized unicompartmental knee system were performed in the US and EU in September last year. "I was involved throughout the production of the personalized restoration." said Prof. Werner Siebert of the Vitos Orthopaedic Clinic in Kassel, Germany, and incoming President of the German Orthopaedic Society, who performed the procedure. "I provided patient imaging, consulted with the Bodycad PREPTech and then reviewed and approved the final design. The result was an exceptional fit for the patient."
Learn more about the personalized unicompartmental knee at the Bodycad product pages.
OrthoGrow expands its Advisory offering with a full range of Quality and Regulatory services. Since full understanding of quality and regulatory implications is a prerequisite for a successful market entry strategy, next to strategic sales advisory, OrthoGrow now has all expertise in-house to offer services in implementation and auditing of Quality Management Systems and product registration according to FDA or EU-MDR regulatory compliance. Furthermore, we can act as your European Authorized Representative through OrthoGrow Distribution, and hereby prepare effective sales startup.
Today, through its EU Authorized Representative OrthoGrow Distribution, Bodycad received product notification confirmation from the Belgian Federal Agency for Medicines and Health Products in Brussels, the legislative capital for the EU, for its personalized unicompartmental knee system. This enables OrthoGrow and Bodycad to commercially launch this truly personalized orthopaedic restoration within the EU, in accordance with current EU Medical Device Directive for custom devices. Bodycad announced FDA 510k clearance for its personalized unicompartmental knee system earlier this year.
Learn more about the personalized knee at the Bodycad product pages.
OrthoGrow Distribution is founded as part of the OrthoGrow group, advisors to the medical device industry, and specializes in (master) distribution and authorized representative services for companies expanding their business in Europe. Through its distribution focused subsidiary, OrthoGrow will be able to extend its abilities to help orthopedic manufacturers grow and accelerate their business in a centralized one-stop-shop principle for local distribution (BeNeLux), master distribution (EU) and associated EU-REP services.