Device Dossier
Inion BioRestoreTM - Graft, bone, synthetic
Device Dossier for Inion BioRestoreTM - Graft, bone, synthetic (Graft, bone, synthetic, Class III, sponsor NATON MEDICAL AUS). ARTG record, intended…
- GMDN category: Graft, bone, synthetic
Intended purpose
The Inion BioRestore™ is a bone graft substitute intended for filling, restoration, and/or augmentation of bony voids or gaps by new bone formation, which is achieved by the osteoconductive and osteostimulative properties of the porous bioactive material.
Functional description
The INION BIORESTORE™ is an osteoconductive and osteostimulative bioactive bone graft device that can be used either separately or in conjunction with autogenous or allograft bone*.The INION BIORESTORE™ consists of different size/shape porous blocks and morsels made of degradable bioactive glass. The surface reaction results in the formation of a calcium phosphate layer.This apatite layer provides scaffolding onto which the patient’s new bone will grow allowing complete repair of the defect.