Device Dossier

ROSA HIP SYSTEM - Robotic surgical system

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

Intended purpose

The ROSA® Hip System for use with the ROSA® RECON platform, is indicated as a fluoroscopic-guided system for total hip arthroplasty (THA). It is used to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of hip implant components provided that the points of interest can be identified from radiology images. The intraoperative cup placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on preoperative planning values optionally determined using compatible X-Ray based surgical planning tools. The ROSA® Hip System is designed for use on a skeletally mature patient population. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the ROSA® Hip System. The ROSA® Hip System is not for primary image interpretation and is applicable for the direct anterior approach.

TGA Public Summary