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Zimmer Biomet Receives FDA Clearance for ROSA Knee

Posted on January 28, 2019


Late last week, Zimmer Biomet ($ZBH) announced FDA 510(k) clearance of their ROSA Knee System for robotically-assisted total knee replacement surgeries. The ROSA Knee features 3D pre-operative planning tools and real-time, intraoperative data on soft-tissue and bone anatomy designed to improve bone cut accuracy and range of motion gap analysis to potentially improve flexion and restoration of natural joint movement.

"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," said Christopher J. Cannova, M.D., Washington Joint Institute at OrthoBethesda. "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."

Of Zimmer Biomet's $7.9 billion in revenue, 35% of it comes from their knee business, helping them achieve #1 in knee marketshare. However, the company has been late to the robotic assisted category in knees as Stryker's Mako platform has been commercially available since March of 2017.

With the FDA clearance, Zimmer Biomet can finally go head-to-head with Stryker.

Additionally, the ROSA Knee leverages Zimmer Biomet's ROSA Robotics platform, which includes ROSA Brain for neurosurgical procedures.

"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," said Ivan Tornos, Group President, Orthopedics. "Zimmer Biomet is committed to leading the industry in bringing differentiated and holistic solutions to market that address the needs of our customers and improve patient outcomes."