Device Dossier

Humeral Head - Humeral head prosthesis

Device Dossier for Humeral Head - Humeral head prosthesis (Humeral head prosthesis, Class III, sponsor Enovis Surgical). ARTG record, intended purpose,…

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 artificial substitute for a diseased or injured humeral head. It is made of metal and designed to be attached to a humeral stem prosthesis and to articulate with the glenoid component as part of a shoulder replacement. It is intended for cemented or cementless use.

TGA Public Summary