Zimmer Biomet wins FDA nod for Rosa Knee robotic surgical system

Zimmer Biomet (NYSE:ZBH) said today that it won FDA 510(k) clearance for its Rosa Knee robotically-assisted total knee replacement surgery platform.
The newly cleared Rosa Knee system includes 3D pre-operative planning tools and real-time intraoperative data on soft tissue and bone anatomy to improve bone cut accuracy and range of motion gap analysis, the Warsaw, Ind.-based company said.
“Complementing the skill and expertise of the surgeon with Rosa Knee’s robotically-assisted technologies can improve accuracy, precision and consistency, which can improve patient satisfaction, clinical outcomes and efficiency. Rosa Knee functions as a surgical assistant that gives me the tools and real-time data to perform bone cuts with greater precision and improve patient-specific soft-tissue balancing and implant alignment, without losing my feel for a natural fit and flexion,” Dr. Christopher Cannova of the Washington Joint Institute at OrthoBethesda said in a prepared statement.
Zimmer Biomet said that the Rosa Knee also features its proprietary X-Atlas imaging protocol, which provides X-ray based preoperative imaging to create a 3D model and plan of the patient’s bone anatomy.
“We are excited for the launch of Rosa Knee, which brings together Zimmer Biomet’s robotics technology with our industry-leading Knee implants to help surgeons personalize surgical procedures for their patients. Zimmer Biomet is committed to leading the industry in bringing d...

Source: Mass Device - January 25, 2019 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Featured Food & Drug Administration (FDA) Orthopedics Regulatory/Compliance Robotics Zimmer Biomet Source Type: news