Device Dossier

Cemex System Genta Evo HV - Orthopaedic cement preparation/delivery kit

Device Dossier for Cemex System Genta Evo HV - Orthopaedic cement preparation/delivery kit (Orthopaedic cement preparation/delivery kit, Class III,…

Intended purpose

Cemex System Genta Evo are intended for the fixation of joint prosthesis (hip, knee) implants to the host bone. Cemex System Genta Evo are indicated where there is the risk or presence of infections caused by organisms susceptible to Gentamicin.

Functional description

Cemex System Genta Evo are sterile, disposable devices for the preparation and application of bone cement pre-dosed with PMMA powder with gentamicin. The system contains: - Radiopaque PMMA bone cement with Gentamicin Sulphate - Cannula for extrusion - Pusher-Rod to extrude the cement from the cannula - Vacuum tube

TGA Public Summary