Device Dossier

Pty Ltd - Equinoxe Replicator Plate - Shoulder humeral body prosthesis

Device Dossier for Pty Ltd - Equinoxe Replicator Plate - Shoulder humeral body prosthesis (Shoulder humeral body prosthesis, Class III, sponsor Advita…

Intended purpose

The Equinoxe Replicator Plate 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 Replicator Plate connects the humeral head to the stem and is used to position the humeral head. It is made of Titanium Alloy.

TGA Public Summary