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 Emergo). ARTG record, intended…

Intended purpose

NanoBone SBX putty is for the reconstruction of bone defects which are not essential for the stability of the bone structure and for augmentation. NanoBone SBX putty can be used for all fields of application for which autologous cancellous bone could be used.

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 a either a standard applicator or in a narrow applicator for quick delivery of the SBX putty (NanoBone QD), which allows for treatment to bone defects smaller and difficult to access areas.

TGA Public Summary