CERAMENT BONE VOID FILLER is a fast-setting, injectable and moldable ceramic bone graft substitute intended for filling bone voids/gaps. The material consists of a powder and a liquid component. The major constituents of the powder are hydroxyapatite and calcium sulfate hemihydrate. The liquid component (C-TRU) contains Iohexol as a radio-contrast enhancer. Mixing the components with the combined mixing injection (CMI) device, results in a viscous material intended to set ex vivo or in vivo.By combining hydroxyapatite and calcium sulfate a balance is achieved between implant resorption rate and bone in-growth rate. Calcium sulfate acts as a resorbable carrier for hydroxyapatite. Hydroxyapatite has a slow resorption rate, high osteoconductivity, promoting bone in-growth and gives long term structural support to newly formed bone.The ceramic bone graft substitute is placed into the bone defect under visual inspection or under radiographic monitoring during open or percutaneous surgery. The paste may be injected into the defect, molded by hand and digitally placed into the defect, or used to prepare beads that are placed into the defect. The accompanying injection device (ID) and Tip Extenders may be used to facilitate the filling of the bone defect.When fully set in vivo, CERAMENT BONE VOID FILLER is drillable and can be used to augment hardware during the surgical procedure.
A sterile bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.