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…
- GMDN category: Orthopaedic cement, medicated
- Sponsor: Stryker
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.