Zimmer Biomet Receives 510(k) Clearance for ROSA Total Knee

Zimmer Biomet announced that they’ve received 510(k) clearance for the ROSA Knee System for robot-assisted total knee replacements. The company said the system’s features include “3D pre-operative planning tools and real-time, intraoperative data on soft-tissue and bone anatomy” to “improve cut accuracy” and offer “range-of-motion gap analysis” to aid in device placement.

Zimmer Biomet acquired the ROSA robotics platform for $132 million in 2017. At that time, it was FDA-cleared (as well as CE-marked) for use in spine and neurosurgical procedures. Zimmer Biomet developed the total knee application internally.

Zimmer Biomet joins Stryker, which offers the Mako total knee, and Smith & Nephew, with the Navio, on the robot-assisted total knee market. Both Mako and Navio can be used in partial knee procedures as well. Rounding out the field is J&J, with their 2018 acquisition of Orthotaxy, which has total and partial knee applications in development. J&J has not revealed when they expect the Orthotaxy platform to receive FDA marketing authorization.