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…
- GMDN category: Orthopaedic cement, medicated
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.