FDA Clearance for Zimmer Biomet’s ROSA Robotic Knee Platform

The FDA has given Zimmer Biomet Holdings, Inc., 510(k) clearance for the company’s ROSA robotically assisted total knee replacement surgery platform.

This follows the clearance for the ROSA Surgical Device in 2010 when French-based MedTech SA owned the technology. That was followed in 2015 with the clearance of ROSA Brain and 2016 for ROSA Spine. Zimmer Biomet bought 59% of MedTech in 2016.

ROSA Knee Platform

The ROSA knee platform, according to the company, 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 platform also features a proprietary X-Atlas imaging protocol which provides the preoperative images.

Christopher Cannova, M.D., of the Washington Joint Institute at OrthoBethesda, said the ROSA, “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.”

In the original 2010 surgical device clearance in 2010, the FDA documents stated the device “is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide.”

Wells Fargo analysts wrote that Zimmer Biomet does not intend for the ROSA system to compete with Stryker Corp’s Mako robotic platform.

The first surgery using the ROSA Knee Robot for a total knee arthroplasty was performed by Dugal James, M.D., at St. John of God Bendigo Hospital in Bendigo, Australia, this past December.

The first cases performed in Australia were actually five surgeries performed in a single day by one surgeon. The analysts noted Zimmer Biomet CEO Bryan Hanson’s comments that the Australian experience demonstrated the efficiency of the platform. Hansen also pointed to a low learning curve as the surgeon that performed five surgeries in the single day operated ROSA for the first time.

The FDA received Zimmer Biomet’s clearance notification on October 25, 2018 and granted the clearance on January 24, 2019. The company also filed an application with the FDA for a spine indication within a week of the total knee notification. That clearance was separate from the previous MedTech notification.