Device Dossier

Optipac® Refobacin® Bone Cement R - Orthopaedic cement, medicated

Device Dossier for Optipac® Refobacin® Bone Cement R - Orthopaedic cement, medicated (Orthopaedic cement, medicated, Class III, sponsor Zimmer Biomet).…

Intended purpose

Optipac® Refobacin® Bone Cement R is indicated to be used for stable anchoring of suitable joint prostheses to the bone, in hip and knee primary arthroplasty operations, also in case an infection with gentamicin-sensitive strains is a potential risk.

Functional description

Optipac® is a mixing and delivery system pre-packed with Refobacin® Bone Cement R. Refobacin® Bone Cement R is a fast-setting polymer, containing gentamicin, for use in bone surgery. Mixing of the two-component system, consisting of a powder and a liquid, initially produces a paste, which is used to anchor the prosthesis to the bone. The closed system minimizes the amount of free monomer in the OR. The application method reduces direct contact with the bone cement.

TGA Public Summary