Device Dossier

heracure one - Graft, bone, synthetic

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

Intended purpose

heracure one is a synthetic, self-setting bone graft substitute for filling non-infected bone defects. heracure one 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 bone defect fractures, e.g. tibia, radius and humerus fractures. - bone defects after resection of benign tumours and cysts - bone defects after removal or replacement of osteosynthesis implants - to support the fixation of osteosynthesis implants (e.g. bone screws)

Functional description

The setting behaviour of heracure one begins after application on contact with body fluids, e.g. blood and tissue fluids. heracure one sets in situ to form a microcrystalline, calcium-deficient hydroxyapatite (CDHA) and alpha-tricalcium phosphate, which form the major phase. The minor phase consists of calcium hydrogen phosphate (monetite) and calcium carbonate (calcite). The reaction product resembles the mineral component of natural bone in its chemical composition and crystalline structure.

TGA Public Summary