MedicalJoint replacement robot
ROSA
ROSA is Zimmer Biomet's surgical robot for joint replacement. ROSA Knee helps surgeons with total knee replacement, including the bone cuts. Zimmer Biomet product page
- Evidence
- Independently reported
- Human help
- Controlled by a surgeon
- Last milestone
- 24 Jan 2019
01Can I get it?
Yes, in places
- Where it works today
- Not stated in our sources.
- Published price
- No published price in our sources.
- Human help
- Zimmer Biomet says the robot does not operate on its own; the surgeon stays in the room and makes all the decisions. Zimmer Biomet patient page
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.
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.
On video
What it looks like, at stage 5
Videos from the maker show the robot at its best. The stage comes from the dated record above, not from what a video shows.
Zimmer Biomet Brand Anthem
Taperloc Complete
Zimmer Biomet and Arnold want you to forget the word “cannot”
Zimmer Biomet and Arnold want to help move you forward
Zimmer Biomet and Arnold know you can do this
RibFix Advantage® Intrathoracic Rib FixationIn clinical trials
7 registered trials
1 looking for volunteers. From ClinicalTrials.gov, read every day.
- Looking for volunteersRobotic Medial Congruent Vs. Conventional Medial Pivot TKAGeorge Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures · Updated 5 March 2025
- Stopped earlyROSA® Hip System THA PMCFZimmer Biomet · Updated 13 Oct 2026
- FinishedEarly Clinical Benefits of Robot-Assisted vs Manual Total Knee Arthroplasty (RATKA-EARLY)Hospital Universitario Santa Cristina · Updated 22 July 2025
- Withdrawn before it beganConventional Instrumentation, Computer Navigation, and Robotic Assistance Techniques in TKAUniversity of California, Los Angeles · Updated 13 Aug 2024
- Under way, not recruitingROSA Knee System vs Conventional Total Knee ArthroplastyZuyderland Medisch Centrum · Updated 24 July 2024
- FinishedComparison of Accuracy and Functional Outcome Between Robotic and Gyroscopic Assisted Surgery in Primary TKAMahidol University · Updated 20 March 2024
- Status not kept up to dateClinical and Radiological Results in Robotic Assisted Knee Prosthetic Surgery With ROSA® Knee SystemBorja Alcobía-Díaz MD, PhD · Updated 6 May 2022
FDA record
16 FDA records
Clearances and recalls from the FDA's own database.
- 510(k) clearanceROSA® Shoulder System21 May 2026 · K260582
- 510(k) clearanceROSA Knee System with UltraSound Imaging Platform (USIP)6 Feb 2026 · K252058
- 510(k) clearanceRosa® Knee System13 Nov 2025 · K251314
- 510(k) clearanceROSA® Knee System18 Oct 2024 · K242864
- 510(k) clearanceROSA® Shoulder System21 Feb 2024 · K233199
- 510(k) clearanceROSA® Knee System29 March 2023 · K230243
- 510(k) clearanceRosa Knee System22 Feb 2023 · K230180
- 510(k) clearanceROSA® Knee System4 Oct 2022 · K221928
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: The FDA cleared the ROSA Knee System through the 510(k) route (K182964). The application was filed by Orthosoft, a Zimmer Biomet company (24 Jan 2019).
- 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. Thin card. We could not confirm ROSA's hip, partial knee or shoulder uses, where it is sold, system or procedure numbers, or any recalls: the shared web search and fetch budgets ran out before this card was researched. The FDA milestone quote is copied from the FDA database table, so its spacing may not match the page exactly.
Sources
Cite this page
Robotics Verdict. “ROSA (Zimmer Biomet): how far has it got?” roboticsverdict.com/robots/zimmer-biomet-rosa. Checked 19 October 2026.
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