Global StepTech APG - Prosthesis, internal, joint, shoulder, glenoid component

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgængelig fra:

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Klasse:

Class III

Fremstillet af:

Depuy Orthopaedics Inc 700 Orthopaedic Drive, Warsaw, IN, 46582 United States Of America

Terapeutisk område:

36259 - Prosthesis, internal, joint, shoulder, glenoid component

Terapeutiske indikationer:

Global StepTech APG replaces the glenoid portion of the humero-glenoid shoulder joint. It is made from highly cross-linked polyethylene and features a central peg for bone graft, three peripheral pegs for cemented fixation and a front face designed to articulate with a humeral head. Three "step" options of polyethylene on the backside surface are designed to compensate for a high degree of scapular bone loss and restore glenoid retroversion. Global StepTech APG is a glenoid component intended for use in total shoulder arthroplasty in combination with a DePuy Synthes humeral head. Global StepTech APG is indicated for use as a replacement of glenoid surfaces disabled by osteoarthritis and traumatic arthritis (when used with all total shoulder systems); rheumatoid arthritis and fracture/dislocations of the humeral head (when used with the Global Shoulder System and Global Unite); avascular necrosis (when used with Global CAP (from the Global Shoulder System) and Global Unite); deformity and/or limited motion (when used with Global CAP (from the Global Shoulder System)); and other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable e.g. revision of a failed primary component (when used with the Global Shoulder System (except Global CAP) and Global Unite).

Autorisation status:

A

Autorisation dato:

2021-12-17