Device Dossier

Rally AB Bone Cement High Viscosity - Orthopaedic cement, medicated

Device Dossier for Rally AB Bone Cement High Viscosity - Orthopaedic cement, medicated (Orthopaedic cement, medicated, Class III, sponsor Compliance…

Intended purpose

RALLY High Viscosity (HV) AB bone cement is indicated 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. RALLY HV AB bone cement is intended for use by suitably qualified orthopaedic surgeons, experienced in arthroplasty procedures, in an operating theatre environment.

Functional description

RALLY high viscosity AB bone cement is a sterile, single use, radiopaque bone cement with Gentamicin Sulphate. It is made of a packet of sterilized powder and a sterile blister pack containing a vial of sterile liquid. RALLY provides the fixation of a prosthesis to the anatomy/bone and allows for even distribution of weight and stresses between bone and prosthesis. The presence of barium sulphate enables radiopacity.

TGA Public Summary