Device Dossier
Actifuse ABX Bone Graft Substitute - Bone matrix implant, artificial
Device Dossier for Actifuse ABX Bone Graft Substitute - Bone matrix implant, artificial (Bone matrix implant, synthetic, Class III, sponsor Baxter…
- GMDN category: Bone matrix implant, synthetic
- Sponsor: Baxter Healthcare
Intended purpose
Bone graft substitutes are intended to be used in place of cortico-cancellous or cancellous allograft or autograft bone. The mechanical environment for such uses experience either low load requirements or compression.; Typical surgical applications for bone graft substitutes are: Small void filling, e.g. after removal of a small bone tumour or following bone fracture reduction or in osteotomies; Spinal fusion, where a cage or screw fixation device is used to relieve the graft site from physiological loads. It is not intended to be used in place of cortical strut allograft bone where high tensile, torsion and/or bending strength are required. The products are used by orthopaedic surgeons in place of allograft bone (bone from humans stored in bone banks).
Functional description
Actifuse ABX bone graft is a mouldable synthetic silicated calcium phosphate delivered in an aqueous polymer, 0.8 wt% silicon is incorporated into the crystalline structure of the calcium phosphate.