Device Dossier

Cemex System Genta - Surgical procedure kit, orthopaedic, bone cement preparation/delivery

Device Dossier for Cemex System Genta - Surgical procedure kit, orthopaedic, bone cement preparation/delivery (Orthopaedic cement preparation/delivery…

Intended purpose

The bone cement is pre-dosed and held within a closed syringe-like device that serves as both a mixing chamber and a cement delivery system. The bone cement is used for the fixation of joint prosthesis implants to the host bone. In particular, these cements are indicated where there is the risk or presence of infections caused by organisms susceptible to Gentamicin.

Functional description

Cemex Genta System are sterile and disposable devices for the preparation and application of radiopaque polymethylmethacrylate bone cements pre-dosed. The powder and liquid components are held separately within a closed syringe-like device that serves as both a mixing chamber and a cement delivery system.

TGA Public Summary