Device Dossier

GlassBONE Injectable Putty - Graft, bone, synthetic

Device Dossier for GlassBONE Injectable Putty - Graft, bone, synthetic (Graft, bone, synthetic, Class III, sponsor Evolution Surgical). ARTG record,…

Intended purpose

GlassBONE Injectable Putty is indicated for the filling of bone defects in dental surgery, orthopaedic surgery, spinal surgery and maxillofacial surgery.

Functional description

GlassBONE Injectable Putty is a synthetic, bioactive and resorbable device for the filling of bone defects. It is an injectable paste composed of 45S5 bioactive glass granules mixed with a resorbable binder combining polyethylene glycol and glycerol. The bioactive granules consist only of elements naturally present in bone tissue. The release of ions allows the surface formation of a layer of carbonated hydroxyapatite, whose composition and structure are similar to the mineral phase of bone.

TGA Public Summary