Device Dossier

Cement spacer mould

Device Dossier for Cement spacer mould (Cement spacer mould, Class IIa, sponsor Heraeus Medical). ARTG record, intended purpose, GMDN category — compiled…

Intended purpose

Sterile single-use moulds used for the preparation of spacers that are intended as temporary knee replacements as part of two-stage septic joint endoprosthesis revision. Includes moulds to prepare femoral and tibial temporary spacers and trial spacer / spacer extensions used to determine the correct height of tibial spacer to prepare.

TGA Public Summary