Device Dossier

Reprobone Fusion - Graft, bone, synthetic

Device Dossier for Reprobone Fusion - Graft, bone, synthetic (Graft, bone, synthetic, Class III, sponsor Prism Surgical Designs). ARTG record, intended…

Intended purpose

Intended for filling and supporting the ingrowth of adjacent viable bone in bone defects located in the extremities, pelvis, spine, dental, peridontal or mandibular areas. Used for fractures, resection or benign tumours or cysts, for filling cages and autograft harvest sites;defects of the alveoloar ridge or wall inclusive extraction sockets and for filling periodontal defects. Intended for a temporary scaffold remaining as a soft paste, not intended to provide structural support

Functional description

ReproBone Fusion is an injectable, granulated bone substitute paste consisting of 83.5% hydroxyapatite paste and 16.5% hydroxyapatite/tricalcium phosphate granules. ReproBone Fusion is biocompatible and designed to act as an osteoconductive medium to support ingrowth and fusion of the adjacent viable bone when placed in an osseous environment. Will fully resorb and be replaced by natural bone due to its osteoconductive structure.

TGA Public Summary