Device Dossier

SmartSet GMV Endurance Gentamicin Bone Cement - Orthopaedic cement, medicated

Device Dossier for SmartSet GMV Endurance Gentamicin Bone Cement - Orthopaedic cement, medicated (Orthopaedic cement, medicated, Class III, sponsor DePuy…

Intended purpose

Indicated for the fixation of prostheses to living bone in arthroplasty procedures of joints in which infection by gentamicin sensitive organisms is a potential risk.

Functional description

Self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. The device relies on close mechanical interlock between irregular bone surface and the prosthesis. It is supplied as a two-component system, consisting of separate, sterile liquid and powder components, which are mixed together at the point of use to produce the cement.

TGA Public Summary