Actifuse Shape - Bone matrix implant, artificial

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 Shape is a synthetic hydroxapatite delivered in a a water-soluble alkylene oxide copolymer carrier. Actifuse Shape is available prepackaged in differnt volumes from 1.6mL to 15.8mL and can be applied directly to the defect site from the primary packaging. Actifuse Shape can also be dispensed into a sterile surgical bowl and mixed with sterile saline/water or autologus blood/bone marrow aspirate to decrease its viscosity to aid handling and then applied to the defect site.