Regulator
CORI won FDA 510(k) clearance for revision knee surgery (redoing an earlier knee replacement), and the first such cases were done.
A regulator's decision · Company-reported · Sets CORI Surgical System's stage
What the source says
“first orthopedics company to win FDA 510(k) clearance for a revision indication”
What it means
CORI Surgical System, from Smith+Nephew, 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. This line rests on the company's own announcement; no regulator, customer or independent report confirms it in our sources yet.
Human help: Our sources report it working without human help.
More on CORI Surgical System
- Smith+Nephew reported the first operations with CORI XT, a new version built for hospitals and outpatient surgery centers. The first knee cases were done at NYU Langone Health.
- Surgeons at Duke Health did the first shoulder replacement operations with CORI.
- Smith+Nephew said 2025 was a record year for CORI sales to hospitals worldwide.
- A year after the US launch, CORI went on sale in Europe, Australia and New Zealand, India and Canada. It is smaller and faster than the company's older Navio robot.
- Smith+Nephew launched CORI for knee surgery in the US.
- The FDA cleared the CORI system through the 510(k) route (K193120, maker Blue Belt Technologies, part of Smith+Nephew).