Device Dossier

Simplex HV with Gentamicin - Orthopaedic cement, medicated

Device Dossier for Simplex HV with Gentamicin - Orthopaedic cement, medicated (Orthopaedic cement, medicated, Class III, sponsor Stryker). ARTG record,…

Intended purpose

For use as a bone cement in prosthetic surgery

Functional description

Simplex® HV with Gentamicin is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. The added antibiotic, gentamicin sulfate, protects the implant and the surrounding tissue from colonization with pathogens that are sensitive to gentamicin.

TGA Public Summary