Device Dossier
ReproBone novo HA Paste - Graft, bone, synthetic
Device Dossier for ReproBone novo HA Paste - Graft, bone, synthetic (Graft, bone, synthetic, Class III, sponsor Prism Surgical Designs). ARTG record,…
- GMDN category: Graft, bone, synthetic
Intended purpose
Intended to be used for filling and supporting the ingrowth of adjacent viable bone in bone defects that are not intrinsic to the stability of the bone structure. These defects may be located in the extremities, pelvis, spine or dental or peridontal or mandibular areas; and used for filling of bone defects in the case of fractures, resection or benign tumours or cysts, for filling cages and for filling autograft harvest sites; defects of the alveoloar ridge or wall inclusive extraction sockets and for filling periodontal defects. Intended to act as a temporary scaffold and will remain as a soft paste and is not intended to provide structural support during hte healing process. Biocompatible, radiopaque and will resorb in a controlled way.
Functional description
ReproBone novo is a mixture of nanocrystalline hydroxyapatite in water. It is biocompatible 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 nanocystalline structure.