Device Dossier

Antibiotic Simplex P with Tobramycin - Orthopaedic cement, medicated

Device Dossier for Antibiotic Simplex P with Tobramycin - Orthopaedic cement, medicated (Orthopaedic cement, medicated, Class III, sponsor Stryker). ARTG…

Intended purpose

Antibiotic Simplex Bone Cement with Tobramycin is indicated as a bone cement in prosthetic surgery.

Functional description

Packaged as a liquid monomer and finely divided powder. Powder and liquid are mixed resulting in exothermic polymeric formation of a soft pliable dough-like mass. As the reaction progresses hard cement like complex is formed, which allows seating and securing of prosthesis to bone. Upon completion of polymerization Simplex with Tobramycin is a buffer for even weight distribution and other stresses between prosthesis and bone. Note: Barium sulfate acts as a contrast medium for X-ray examination.

TGA Public Summary