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).…
- GMDN category: Orthopaedic cement, medicated
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.