Device Dossier

Cerament Bone Void Filler - Bone matrix implant, synthetic

Device Dossier for Cerament Bone Void Filler - Bone matrix implant, synthetic (Bone matrix implant, synthetic, Class III, sponsor Akva Surgical). ARTG…

Intended purpose

CERAMENT®|BONE VOID FILLER is a resorbable ceramic bone graft substitute intended to fill gaps and voids in the skeletal system to promote bone healing. CERAMENT®|BONE VOID FILLER provides a void/gap filler that during the surgical procedure can augment hardware and bone alignments.

Functional description

CERAMENT®|BONE VOID FILLER is an injectable and moldable ceramic bone graft substitute intended for filling bone voids/gaps. The material consists of a powder and a liquid component. The major constituents of the powder are hydroxyapatite and calcium sulfate hemihydrate. The liquid component (C-TRU) contains Iohexol as a radio-opacification enhancer. Mixing the components, with the combined mixing injection (CMI) device, results in a viscous material intended to set ex-vivo or in-vivo.

TGA Public Summary