Device Dossier
Rosa Partial Knee System - Robotic surgical system
Device Dossier for Rosa Partial Knee System - Robotic surgical system (Robotic surgical system, Class IIa, sponsor Zimmer Biomet). ARTG record, intended…
- GMDN category: Robotic surgical system
Intended purpose
The ROSA® Partial Knee System, for use with the ROSA® RECON platform, is indicated as a stereotaxic instrumentation system for Partial Knee replacement (PKA) 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 the knee implant components. The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and optionally based on a three-dimensional representation of the bone structures determined preoperatively using compatible X-ray or MRI based imaging technologies. It includes a robotic arm, an optical sensor navigation system and accessories, software system, surgical instruments and accessories. The ROSA® Partial Knee 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® Partial Knee System. The ROSA® Partial Knee System is to be used with Persona Partial Knee (PPK) fixed bearing knee replacement system in accordance with its indications and contraindications..