Device Dossier

Copal G+C Bone Cement - Orthopaedic cement, medicated

Device Dossier for Copal G+C Bone Cement - Orthopaedic cement, medicated (Orthopaedic cement, medicated, Class III, sponsor Heraeus Medical). ARTG…

Intended purpose

COPAL G+C is a PMMA bone cement intended for stable anchoring of total or partial joint endoprostheses in living bone. COPAL G+C is indicated for surgical treatment such as - anchoring of endoprosthesis in primary and revision arthroplasty procedures of ▪ hip ▪ knee ▪ ankle ▪ shoulder ▪ elbow

Functional description

A radiopaque, high viscosity, rapid-curing bone cement containing gentamicin sulphate and clindamycin hydrochloride for infection prophylaxis. It consists of a polymer powder component and a liquid monomer component. Zirconium oxide is added as an X-ray contrast medium. After mixing, a plastic dough is obtained which is filled into the bone as an anchoring medium. The cement which then hardens in the bone allows stable fixation of the endoprostheses.

TGA Public Summary