Device Dossier
Pty Ltd - Equinoxe Fixed Angle Replicator Plate Kit - Shoulder humeral body prosthesis
Device Dossier for Pty Ltd - Equinoxe Fixed Angle Replicator Plate Kit - Shoulder humeral body prosthesis (Shoulder humeral body prosthesis, Class III,…
- GMDN category: Shoulder humeral body prosthesis
Intended purpose
The Equinoxe Fixed Angle Replicator Plate Kit is intended to connect the humeral head to the stem and to position the replacement humeral head 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 Fixed Angle Replicator Plate Kit connects the humeral head to the stem and is used to position the humeral head. The Fixed Angle Replicator Plate is used when surgeons prefer not to adjust neck angle and humeral head retroversion. The Fixed Angle Replicator Plate Kit is a sterile package with one fixed angle replicator plate (made of Titanium alloy), one torque defining screw, and one driver.