Device Category Dossier

Humeral stem trial prosthesis

Device Category Dossier for Humeral stem trial prosthesis. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Humeral stem trial prostheses are copies of final humeral stem prostheses designed to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. These surgical instruments are intended for use during shoulder or elbow arthroplasty, or trauma surgeries, to evaluate the patient's joint surface anatomy following bone preparation and facilitate the physician's determination of approximate implant size for the corresponding total joint replacement component.