Regulator
The FDA cleared the CORI system through the 510(k) route (K193120, maker Blue Belt Technologies, part of Smith+Nephew).
A regulator's decision · Sets CORI Surgical System's stage
What the source says
“The CORI Surgical System has received 510K clearance from the U.S. Food and Drug Administration”
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.
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.
- CORI won FDA 510(k) clearance for revision knee surgery (redoing an earlier knee replacement), and the first such cases were done.
- 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.