Device Dossier
NanoBone Granulate - Bone matrix implant, synthetic
Device Dossier for NanoBone Granulate - Bone matrix implant, synthetic (Bone matrix implant, synthetic, Class III, sponsor Emergo). ARTG record, intended…
- GMDN category: Bone matrix implant, synthetic
Intended purpose
NanoBone Granulate is a bone void filler material that is intended to be used for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. It is a sterile bioabsorbable device made of synthetic material intended to be implanted into the body and is provided in granulate form of various sizes.
Functional description
NanoBone bone void filler material is made up of synthetic nanocrystalline hydroxylapatite (HA) which is embedded in a silica gel matrix (amorphous SiO2). It is supplied in granulate form. The granulate is mixed or saturated with patient's own venous blood, or with physiological saline, before implantation and the bone defect is completely filled with NanoBone. Depending on the nature and location of the bone defect, additional osteosynthetic measures are required to stabilise the material.