Device Dossier

NanoBone SBX Putty - Bone matrix implant, synthetic

Device Dossier for NanoBone SBX Putty - Bone matrix implant, synthetic (Bone matrix implant, synthetic, Class III, sponsor My Biologics). ARTG record,…

Intended purpose

NanoBone® | SBX putty is a phase-pure non-sintered synthetic biodegradable bone void filler material consisting of NanoBone® | granulate S39 nanocrystalline osteoconductive hydroxyapatite and a water soluble carrier material containing poloxamer, which is embedded in a silica gel matrix of granulate porosity of approx. 80 %. The device is provided sterile either in a standard applicator or in a narrow applicator for quick delivery of the SBX putty (NanoBone® QD), which allows for the treatment of bone defects of smaller and difficult to access areas.

Functional description

NanoBone SBX putty is a synthetic, biodegradable bone void filler material consisting of NanoBone granulate S39 nanocrystalline hydroxyapatite and a water soluble carrier material containing poloxamer which is embedded in a silica gel matrix of granulate porosity of approx 80%. The device is provided in either a standard applicator or in a narrow applicator for quick delivery of the SBX putty (NanoBone QD), which allows for treatment of bone defects in smaller and difficult to access areas.

TGA Public Summary