ROSA Shoulder System - Robotic surgical system - ARTG 449788
Access comprehensive regulatory information for ROSA Shoulder System - Robotic surgical system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 449788 and sponsored by Zimmer Biomet Pty Ltd, manufactured by Zimmer CAS in Canada. The device registration started on May 28, 2024.
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.
The ROSA Shoulder System, for use with the ROSA RECON platform, is indicated as a stereotaxic instrumentation system for Total Shoulder Arthroplasty (TSA) surgery. It is used to assist the surgeon in providing software-defined spatial boundaries for orientation and reference to identifiable anatomical structures for the accurate placement of the shoulder implant components. The robotic arm placement is performed relative to anatomical landmarks and bony anatomy as recorded using the system intraoperatively, and based on a three-dimensional representation of the bone structures determined pre-operatively using compatible CT based imaging technology. It includes a robotic arm, an optical sensor navigation system and accessories, software system, surgical instruments and accessories. The ROSA Shoulder System is designed for use on a skeletally mature patient population. The target population has the same characteristics as the population targeted by the implants compatible with the ROSA Shoulder System.