Regulator
The FDA cleared the ROSA Knee System through the 510(k) route (K182964). The application was filed by Orthosoft, a Zimmer Biomet company.
A regulator's decision · Sets ROSA's stage
What the source says
“510(k) Number K182964 Device Name ROSA Knee System Applicant Orthosoft Inc (D/B/A Zimmer Cas)”
What it means
ROSA, from Zimmer Biomet, is at stage 5 of 5 on our ladder: regulator-cleared or mass market. This event is one of the milestones that placed it there.
Human help: A surgeon in the operating room controls it; it doesn't operate on its own.