Device Dossier

Pty Ltd - Equinoxe Humeral Reconstruction Prosthesis Taper Locking Screw - Shoulder prosthesis screw

Device Dossier for Pty Ltd - Equinoxe Humeral Reconstruction Prosthesis Taper Locking Screw - Shoulder prosthesis screw (Shoulder prosthesis screw, Class…

Intended purpose

The Equinoxe Humeral Reconstruction Prosthesis Taper Locking Screw is part of a modular humeral stem system of interlocking parts so the length can be configured intraoperatively. The Taper Locking Screw locks the final set of modular segments in place. 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 Equinoxe Humeral Reconstruction Prosthesis Taper Locking Screw is part of a modular humeral stem system for patients with significant proximal humeral resection. The Taper Locking Screw components lock the final set of modular segments in place and are provided in various lengths to accommodate various modular assembly lengths. The devices are made from Ti alloy.

TGA Public Summary