Device Dossier

Coated shoulder humeral stem prosthesis

Device Dossier for Coated shoulder humeral stem prosthesis (Coated shoulder humeral stem prosthesis, Class III, sponsor Enovis Surgical). ARTG record,…

Intended purpose

Intended for treatment of patients who are candidates for shoulder arthroplasty. While shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

Functional description

A sterile implantable device designed to provide fixation within the proximal humerus. It is intended for use with a humeral neck component that provides a site of attachment for the humeral head prosthesis. The stem has a porous coating and is intended for use without cement.

TGA Public Summary