Zimmer Biomet Gains FDA Clearance for ROSA Partial Knee

By Julie A. Vetalice

Zimmer Biomet Gains FDA Clearance for ROSA Partial Knee

Zimmer Biomet announced FDA 510(k) clearance to market the ROSA® Partial Knee System for robotically-assisted partial knee replacement. The ROSA Partial Knee is now a component of ZBEdge, bringing another robotic solution to Zimmer Biomet's suite of integrated digital and robotic technologies.

The ROSA Partial Knee System is designed for compatibility with Persona® Partial Knee. The system features proprietary 2D to 3D X-Atlas™ imaging and real-time, intraoperative data collection on soft tissue and bone anatomy to improve bone cut accuracy and range of motion gap analysis.

As a part of ZBEdge, intra-operative data collected by the ROSA Partial Knee can be combined with pre- and post-operative data collected by mymobility® with Apple Watch®, a remote care management platform. This data can then be consolidated and analyzed by OrthoIntel, an orthopedic intelligence platform designed to uncover new clinical insights throughout the episode of care and help surgeons and care teams make informed decisions and optimize care.

"The FDA clearance of the ROSA Partial Knee System just two years after the introduction of the ROSA Total Knee System builds on the success of our ROSA robotics portfolio, which is designed to help enhance surgical accuracy, precision and efficiency, through the use of intraoperative data that can personalize each procedure. As a result, the ROSA Partial Knee System empowers patients to truly get the knee that's the best fit for their needs," said Ivan Tornos, Chief Operating Officer at Zimmer Biomet.


Product Labels: Knee Replacement, Robot-Assisted Systems

Tags: 510(k) Clearance, Regulatory