Device Dossier

heracure 3D - Graft, bone, synthetic

Device Dossier for heracure 3D - Graft, bone, synthetic (Graft, bone, synthetic, Class III, sponsor Heraeus Medical). ARTG record, intended purpose, GMDN…

Intended purpose

heracure 3D is a synthetic, porous bone substitute material for filling non-infected bone defects. heracure 3D is intended for filling non-infected and non-loadbearing bone defects or for the filling of bone defects that have been sufficiently stabilised by means of suitable measures. Fields of application are in particular: - metaphyseal defect fractures, e.g. fractures of the tibia, radius, humerus - osteotomy - bone defects after removal or replacement of osteosynthesis implants

Functional description

Pre-shaped blocks, cylinders or wedges. Can be customized, which allows the free space to be completely filled. After insertion into the defect, the outer & inner surfaces are wetted with the body's own blood. The interconnecting pore system enables ingrowth of blood vessels & formation of new bone, which leads to a form- and material-locking integration into the surrounding tissue. In addition, osteoblasts and osteoclasts can successively convert the bone replacement material into natural bone.

TGA Public Summary