Device Dossier

Reprobone Resorbable HA/TCP Bone Graft Substitute Granules - Graft, bone, synthetic

Device Dossier for Reprobone Resorbable HA/TCP Bone Graft Substitute Granules - Graft, bone, synthetic (Graft, bone, synthetic, Class III, sponsor Prism…

Intended purpose

ReproBone® is a synthetic osteoconductive bone substitute in block and granular form that is intended to be used as a scaffold to support the ingrowth of adjacent viable bone in defects that are not intrinsic to the stability of the bone structure. These defects may be located in the extremities, spine, pelvis or cranium, and ReproBone® may also be used in the same manner during hip surgery and hip revision surgery. The blocks or granules may be gently pressed into the defect by hand or shaped to more accurately fit the defect, and may also be soaked with bone marrow aspirate prior to implantation. Repro-Bone® will act as a temporary scaffold and is not intended to provide structural support during the healing process. The implant is biocompatible, radio-opaque and will eventually resorb in a controlled way

Functional description

ReproBone® is a mixture having a nominal composition of 60% hydroxyapatite and 40% ?-tricalcium phosphate. ReproBone® is a safe and fully biocompatible material which is designed to act as an osteoconductive scaffold to support the ingrowth and fusion of adjacent viable bone when placed in an osseous environment. ReproBone® will later resorb and be replaced by natural bone.

TGA Public Summary