Monday, October 26, 2026 · Daily editionET --:--:--

MedicalHandheld knee surgery robot

CORI Surgical System

by Smith+Nephew

CORI is a handheld robotic tool that helps surgeons shape bone during knee replacement. It uses a 3D picture of the knee made during surgery to guide the cut. The Robot Report, 14 July 2020

5

Stage 5 of 5

Regulator-cleared or mass market

Which rule placed it
Evidence
Independently reported
Human help
None reported
Last milestone
8 June 2026

01Can I get it?

Yes, in places

Where it works today
Sold to hospitals and outpatient surgery centers in the US, Europe, Australia and New Zealand, India and Canada. MassDevice, 24 Nov 2021
Published price
No published price in our sources.
Human help
The surgeon holds and moves the tool; the robot limits where it can cut.

03Safety and incidents

What has gone wrong

No crashes, recalls or regulator reports in our sources. That is not proof none happened; we add them when a regulator or trusted outlet reports one.

How we placed it

The rule, not an opinion

Stages are worked out by published rules from the dated milestones above. We never rate robots, and no maker can pay to change a stage.

  1. 5

    Regulator-cleared or mass marketThis robot

    A regulator has cleared it where approval applies: FDA clearance or approval for a medical robot, a permit to run with no one aboard for a self-driving vehicle, or an FAA approval for routine drone flights. Or: Widely sold: sales in the hundreds of thousands, or a product category you can buy in ordinary shops.

    Placed by: CORI won FDA 510(k) clearance for revision knee surgery (redoing an earlier knee replacement), and the first such cases were done (26 Sept 2022); The FDA cleared the CORI system through the 510(k) route (K193120, maker Blue Belt Technologies, part of Smith+Nephew) (14 Feb 2020).

  2. 4

    Paying customers

    Delivered to customers who pay for it, beyond a trial, or a paid service the public can use.

  3. 3

    Pilot

    Working with a named customer in a real setting, as a trial.

  4. 2

    Pre-orders

    Orders, reservations or deposits taken, with nothing delivered yet.

  5. 1

    Demo only

    Shown in videos, staged events or a factory, with no units working for customers.

What we couldn't confirm. No count of installed CORI systems was found. The FDA clearance status of CORI XT was not stated in the source found.