Australia TGA ARTG recordGlobal StepTech APG - Prosthesis, internal, joint, shoulder, glenoid component
Australia TGA ARTG Registered Device · Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes · Depuy Orthopaedics Inc · Class III · Started December 17, 2021
Good Name: Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes - Global StepTech APG - Prosthesis, internal, joint, shoulder, glenoid component
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- December 17, 2021
- Effective Date
- December 17, 2021
- Country
- United States of America
- Address
- 700 Orthopaedic Drive, Warsaw, IN, 46582
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).
Access comprehensive regulatory information for Global StepTech APG - Prosthesis, internal, joint, shoulder, glenoid component in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes, manufactured by Depuy Orthopaedics Inc in United States of America. The device registration started on December 17, 2021.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.