Device Dossier

Femoral stem trial prosthesis

Device Dossier for Femoral stem trial prosthesis (Femoral stem trial prosthesis, Class IIa, sponsor Zimmer Biomet). ARTG record, intended purpose, GMDN…

Intended purpose

A copy of a final femoral stem prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct offset, leg-length, and range of motion of the final femoral prosthesis to be implanted. Designed to mirror the shape of stem implants and have a taper for assembling the trial head. Typically made of metal or polymer material and includes trial stems and trial necks. This is a reusable device intended to be sterilized prior to use.

TGA Public Summary