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
- 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.
02Track record
What has actually happened
Every milestone is dated and links to the page it comes from. Lines marked company-reported rest on the maker's own word.
Cleared · sets the stage
MassDevice, 26 Sept 2022Company-reported
On sale
Smith+Nephew launched CORI for knee surgery in the US.
The Robot Report, 14 July 2020Company-reported
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.
In clinical trials
11 registered trials
From ClinicalTrials.gov, read every day.
- Under way, not recruitingNavio Robotic Versus Conventional Total Knee ArthroplastyColumbia University · Updated 15 Sept 2026
- FinishedTo Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System.Smith & Nephew, Inc. · Updated 30 June 2026
- By invitation onlyComparison Between Velys J&J Robotic-assisted and Cori S&N Robotic-assisted Total Knee ArthroplastyJan Biziel University Hospital No 2 in Bydgoszcz · Updated 24 June 2026
- FinishedEvaluation Protocol of the Installation of Knee Unicompartmental Prosthesis (Journey (Smith & Nephew)) With Mechanical Ancillary Versus Robotic Assisted (Navio System).Hospices Civils de Lyon · Updated 19 Dec 2025
- FinishedNavio With Total Knee ArthroplastySmith & Nephew, Inc. · Updated 8 Oct 2024
- Status not kept up to dateOpen and Closed Platform Robotic-assisted Versus Conventional Total Knee ArthroplastyChinese University of Hong Kong · Updated 19 March 2024
- Withdrawn before it beganA Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional InstrumentationSmith & Nephew Orthopaedics AG · Updated 11 July 2022
- Withdrawn before it beganA Comparison of Patients Receiving a Unicompartmental Knee Replacement With Robotic Assistance or With Conventional InstrumentationSmith & Nephew Orthopaedics AG · Updated 29 June 2022
FDA record
10 FDA records
Clearances and recalls from the FDA's own database.
- RecallCORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S13 Nov 2023
- RecallReal Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB102997 Sept 2023
- RecallNAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navio bone clamps and potentially reduce…27 Feb 2020
- 510(k) clearanceNAVIO28 June 2019 · K191223
- 510(k) clearanceNAVIO Surgical System (NAVIO system)6 April 2018 · K180271
- 510(k) clearanceNAVIO2 May 2017 · K170360
- 510(k) clearanceNavio19 May 2016 · K160537
- 510(k) clearanceNavio20 Oct 2015 · K152574
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.
- 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).
- 4
Paying customers
Delivered to customers who pay for it, beyond a trial, or a paid service the public can use.
- 3
Pilot
Working with a named customer in a real setting, as a trial.
- 2
Pre-orders
Orders, reservations or deposits taken, with nothing delivered yet.
- 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.
Sources
- 01The Robot Report, 14 July 2020
- 02MassDevice, 24 Nov 2021
- 03MassDevice, 8 June 2026
- 04MassDevice, 3 Mar 2026
- 05OrthoWorld, 5 Mar 2026
- 06MassDevice, 26 Sept 2022
Cite this page
Robotics Verdict. “CORI Surgical System (Smith+Nephew): how far has it got?” roboticsverdict.com/robots/smith-nephew-cori. Checked 19 October 2026.
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