Device Dossier

Pty Ltd - Equinoxe Humeral Head - Humeral head prosthesis

Device Dossier for Pty Ltd - Equinoxe Humeral Head - Humeral head prosthesis (Humeral head prosthesis, Class III, sponsor Advita Ortho AUS). ARTG record,…

Intended purpose

The Equinoxe Humeral Head is intended to replace the articular surface of the patient's humerus as part of a shoulder joint replacement. The device is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.

Functional description

The Equinoxe Humeral Head connects to the humeral stem via replicator plate and serves to replace the articular surface of the patient's humerus as part of a shoulder replacement. The Equinoxe Humeral Heads are made of CoCr alloy.

TGA Public Summary