Device Dossier

COPAL G+C pro - Orthopaedic cement, medicated

Device Dossier for COPAL G+C pro - Orthopaedic cement, medicated (Orthopaedic cement, medicated, Class III, sponsor Heraeus Medical). ARTG record,…

Intended purpose

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

Functional description

COPAL G+C pro is a high-viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). It contains antibiotics to protect the cured bone cement and surrounding tissue from colonization by bacteria sensitive to gentamicin and/or clindamycin. The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder) with the monomer liquid.

TGA Public Summary