We are delighted to share that the Inion BioRestore™ and Inion BioRestore™ Plus have been CE certified according to the new EU Medical Device Regulation by our Notified Body British Standards Institute (BSI) as of April 22nd, 2024. The MDR certification represents an important advancement in the availability of the Inion BioRestore™ products, ensuring compliance with the highest European standards for patient safety and product quality.
Different forms of Inion BioRestore™
Inion BioRestore™ is a synthetic bone graft substitute, which remodels into bone. The product is available in morsel form and shaped blocks. Inion BioRestore™ Plus blocks have slightly improved shaping characteristics. The granules are also available in easy-to-use syringes.
Inion BioRestore™
Inion BioRestore™ is a synthetic bone graft substitute, which remodels into bone and is easy to use. Inion BioRestore™ is made of degradable bioactive glass, which once in contact with the natural body fluids forms a silica gel and calcium phosphate layer, providing scaffolding for the new bone tissue to be formed.
Inion BioRestore™ is a CE-marked medical device (Class III), manufactured by Inion Oy. The conformity assessment was conducted by BSI The Netherlands (CE 2797).
