Device Dossier

Signature-X Cement SV - Orthopaedic cement, medicated

Device Dossier for Signature-X Cement SV - Orthopaedic cement, medicated (Orthopaedic cement, medicated, Class III, sponsor Signature Orthopaedics). ARTG…

Intended purpose

Signature-X Cement SV is a high viscosity bone cement with gentamicin intended for use in the fixation of prosthetic components into bone medullar cavity in arthroplasty procedures.

Functional description

Signature-X Cement SV is an orthopaedic bone cement hat consists of a powder and a liquid component which, after mixing, form a plastic paste which self-sets after implantation within the body.

TGA Public Summary