Device Dossier

Optipac Refobacin Plus Bone Cement - Orthopaedic cement, medicated

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

Intended purpose

Optipac Refobacin Plus Bone Cement is used for stable anchoring of suitable joint prostheses in primary operations, with added protection against infection also in revision operations resulting from aseptic loosening of the prosthesis and infection of the prosthesis by gentamicin-sensitive strains.

Functional description

Optipac is a mixing and application system pre-packed with Refobacin Plus Bone Cement. Refobacin Plus Bone Cement 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 for OR staff.

TGA Public Summary