Device Dossier

Pty Ltd - Equinoxe Humeral Reconstruction Prosthesis Proximal Body - Shoulder humeral body prosthesis

Device Dossier for Pty Ltd - Equinoxe Humeral Reconstruction Prosthesis Proximal Body - Shoulder humeral body prosthesis (Shoulder humeral body…

Intended purpose

The Equinoxe Humeral Reconstruction Prosthesis Proximal Body is part of a modular humeral stem system of interlocking parts so the length can be configured intraoperatively. The Proximal Body forms the connection between the humeral stem and the humeral head or humeral liner. It is for use in primary and revision cases with significant proximal humeral resection in cases of non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, rheumatoid arthritis, revision where other devices or treatments have failed, correction of functional deformity, treatment of acute or chronic fracture with humeral head involvement, which are unmanageable using other treatment, traumatic arthritis, oncology applications including bone loss due to tumor resection, or significant humeral resection which are unmanageable using other treatment methods.

Functional description

The Proximal Body is part of a modular humeral stem system for patients with significant proximal humeral resection. It connects via replicator plate to the humeral head or via humeral adapter tray to the humeral liner as part of a shoulder joint replacement. The system includes various sizes of proximal bodies to accommodate various humeral resection heights. The components provide the option for tissue stabilization and attachment. The devices are made from Ti alloy with cp Ti coating.

TGA Public Summary