Device Category Dossier

Cement, orthopaedic, bone spacer

Device Category Dossier for Cement, orthopaedic, bone spacer. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Device: Synicem Shoulder Spacer with Gentamicin - Cement, orthopaedic, bone spacer
Device: Synicem Hip Spacer with Gentamicin - Cement, orthopaedic, bone spacer
Device: Synicem Evolution Knee Spacer with Gentamicin - Cement, orthopaedic, bone spacer
Device: Spacer-S - Cement, orthopaedic, bone spacer
Device: Spacer-G Flat Stem - Cement, orthopaedic, bone spacer
Device: Cement, orthopaedic, bone spacer
Device: Spacer G - Cement, orthopaedic, bone spacer
Device: Spacer K - Cement, orthopaedic, bone spacer
Device: Cement, orthopaedic, bone spacer

Gentamicin spacers are temporary implants with a maximum duration of 180 days that maintain joint space during two-stage revision arthroplasty whilst assisting in treating joints infected by gentamicin-sensitive pathogens. These devices are used in a two-stage procedure where an infected prosthesis is first removed and the spacer is placed, then after completing specific treatment and confirming absence of infection, the spacer is removed and a new definitive prosthesis is fitted.