Bodycad has received product notification confirmation from the Belgian Federal Agency for Medicines and Health Products for its Bodycad Unicompartmental Knee System. This enables Bodycad to commercially launch within the European Union in accordance with EU Medical Device Directive for custom devices.
Bodycad’s Unicompartmental Knee System is based on proprietary 3D renderings of medical images of the patient’s anatomy. The product is described as a personalized restoration, and is delivered as a “procedure in a box” with the patient-specific implant and instruments.
This announcement follows Bodycad’s March FDA 510(k) clearance, which was their first 510(k) clearance, and continues the introduction of personalized, custom devices in the knee industry. Bodycad is the first Canadian company to receive EU product notification confirmation for a joint reconstruction implant system.
Source: Bodycad, BONEZONE®