Device Dossier

Pty Ltd - Equinoxe Platform Fracture Humeral Stem, Cemented - Uncoated shoulder humeral stem prosthesis

Device Dossier for Pty Ltd - Equinoxe Platform Fracture Humeral Stem, Cemented - Uncoated shoulder humeral stem prosthesis (Uncoated shoulder humeral…

Intended purpose

The Equinoxe Platform Humeral Stem is intended to connect the humeral head replacement to the patient's humerus as part of a shoulder joint replacement. The device is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemi-arthroplasty), acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty), or acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty).

Functional description

The Equinoxe Platform Humeral Fracture Stem is implanted in the patient's humerus and connects via replicator plate to the humeral head as part of a shoulder joint replacement or via humeral adapter tray to the humeral liner as part of a reverse shoulder joint replacement.The device has an anterior-lateral fin and asymmetric tuberosity beds that act as a scaffold to accurately position the greater and lesser tuberosity. Made from Ti-6Al-4V (titanium alloy).

TGA Public Summary