Device Dossier

Palacos R+G pro - Cement, orthopaedic, bone

Device Dossier for Palacos R+G pro - Cement, orthopaedic, bone (Orthopaedic cement, medicated, Class III, sponsor Heraeus Medical). ARTG record, intended…

Intended purpose

PALACOS® R+G pro is a PMMA bone cement intended for stable anchoring of total or partial joint endoprostheses in living bone as well as for reconstruction of bone. PALACOS® R+G pro is indicated for surgical treatment such as – anchoring of endoprosthesis in primary and revision arthroplasty procedures of • hip • knee • ankle • shoulder • elbow – reconstruction of bone via induced membrane technique after tumor surgery and/or trauma

Functional description

PALACOS R+G pro is the fast-curing radiopaque poly(methyl methacrylate) based PALACOS R+G bone cement, packed in a closed mixing and application system ready-to-mix. Contains the antibiotic gentamicin for protection of the cured cement and contiguous tissue against colonisation by microorganisms sensitive to gentamicin. The cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. This forms a ductile dough, which sets within a few minutes.

TGA Public Summary