Device Dossier

ROSA® KNEE SYSTEM - Robotic surgical system

Device Dossier for ROSA® KNEE SYSTEM - Robotic surgical system (Robotic surgical system, Class IIa, sponsor Zimmer Biomet). ARTG record, intended…

Intended purpose

The ROSA® Knee System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components. The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan, optionally determined pre-operatively using compatible X-ray or MRI based surgical planning tools. It includes a robotic arm, an optical sensor navigation system and accessories, software system, surgical instruments and accessories.

TGA Public Summary