Device Dossier
Pty Ltd - Equinoxe Humeral Stem, Primary, Press-Fit - Prosthesis, internal, joint, shoulder, total
Device Dossier for Pty Ltd - Equinoxe Humeral Stem, Primary, Press-Fit - Prosthesis, internal, joint, shoulder, total (Prosthesis, internal, joint,…
- GMDN category: Prosthesis, internal, joint, shoulder, total
Intended purpose
The Equinoxe 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 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 Stem is implanted in the patient's humerus and connects via replicator plate to the humeral head as part of a shoulder joint replacement. The humeral stem is made of Ti-6Al-4V. It has a trapezoidal proximal geometry and a cylindrical with flutes distal geometry. In addition, the proximal surface is coated with 16 grade grit blast, whilst the distal surface is Hi-Brite Polish.