Device Dossier

Humeral head trial prosthesis, reusable

Device Dossier for Humeral head trial prosthesis, reusable (Humeral head trial prosthesis, reusable, Class IIa, sponsor Zimmer Biomet). ARTG record,…

Intended purpose

A copy of a final humeral head device designed to be used during primary or revision orthopaedic surgery to validate the proper size of the permanent device required by the patient, to ensure its proper orientation and positioning, and to verify proper dimensions. It has a cup-like ball shape and can be available in types such as concentric head fixation, eccentric head fixation, cuff tear arthropathy (CTA), or types for revision surgery. It is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use

TGA Public Summary