Device Dossier
Pty Ltd - Equinoxe Humeral Reconstruction Prosthesis Distal Stem - Uncoated shoulder humeral stem prosthesis
Device Dossier for Pty Ltd - Equinoxe Humeral Reconstruction Prosthesis Distal Stem - Uncoated shoulder humeral stem prosthesis (Uncoated shoulder…
- GMDN category: Uncoated shoulder humeral stem prosthesis
Intended purpose
The Equinoxe Humeral Reconstruction Prosthesis Distal Stem is part of a modular humeral stem system of interlocking parts so the length can be configured intraoperatively. The Distal Stem provides fixation within the humerus and connects to the middle segments. 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 Distal Stem is part of a modular humeral stem system for patients with significant proximal humeral resection. The Distal Stem provides fixation within the humerus and connects to the middle segments. The system allows for use of various lengths and diameters of distal stems to accommodate various humeral resection heights and patient anatomy. The devices are made from Ti alloy.