Device Dossier

ceramys Revision Head - Ceramic femoral head prosthesis

Device Dossier for ceramys Revision Head - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III, sponsor Enovis Surgical). ARTG…

Intended purpose

Ceramys femoral head manufactured from ZrO2‐Al2O3 with an internal titanium sleeve for use in primary and revision hip surgery.

Functional description

Ceramys femoral heads are manufactured from ZrO2‐Al2O3 with an internal titanium sleeve and a 12/14 cone. The heads can be used in combination with all commercially available UHMW‐PE, highly crosslinked PE, Bionit and ceramys in both primary and revision hip surgery. Ceramys femoral heads with sleeve can be placed either onto a new cone or onto a cone with slight abrasion (height <0.4mm) if the stem is left in situ during revision surgery.

TGA Public Summary