MedicalJoint replacement robot
Mako
by Stryker
Mako is Stryker's robotic-arm system that helps surgeons with joint replacement operations, such as knee replacement. Stryker uses it across several surgical specialties. Stryker news release, 9 Feb 2026
- Evidence
- Company-reported only
- Human help
- Not disclosed
- Last milestone
- 16 July 2026
01Can I get it?
Yes, in places
- Where it works today
- Sold to hospitals in 47 countries, Stryker says, with more than 2.5 million operations done by July 2026. Stryker news release, 16 July 2026
- Published price
- No published price in our sources.
- Human help
- The maker hasn't said whether people help it remotely.
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.
Mass market · sets the stage
Stryker said Mako was installed in 35 countries and had been used in more than 1 million operations.
Stryker feature, 6 July 2023Company-reported
On sale
Stryker launched Mako for total knee replacement.
Stryker feature, 6 July 2023Company-reported
Funding
Stryker bought MAKO Surgical Corp., the company that made Mako.
Stryker feature, 6 July 2023Company-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
28 registered trials
10 looking for volunteers. From ClinicalTrials.gov, read every day.
- Looking for volunteersTotal Versus Robotic Assisted Unicompartmental Knee ReplacementNHS Lothian · Updated 23 Sept 2026
- Looking for volunteersMako-MORE RegistryStryker Orthopaedics · Updated 18 Aug 2026
- Looking for volunteersComparative Study of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee ArthroplastyAesculap AG · Updated 27 March 2026
- Looking for volunteersFunctional Impact at 12 Months Post-op of Posterior Cruciate Ligament Conservation During Robotic-assisted Surgery (MAKO) for Total Knee Replacement.Centre Hospitalier Universitaire de Nīmes · Updated 27 March 2026
- Looking for volunteersMako Cementless TKA vs Mako Cemented TKAUniversity College, London · Updated 20 Feb 2026
- Not recruiting yetRobotic-assisted (MAKO) Versus Manual Total Knee Arthroplasty for Knee OsteoarthritisSatakunta Central Hospital · Updated 1 Oct 2025
- Looking for volunteersRCT: Mako Medial Unicondylar Knee Arthroplasty vs Oxford Unicondylar Knee ArthroplastyUniversity College, London · Updated 9 July 2025
- Not recruiting yetComparison of Functional Recovery Between Restricted Inverse Kinematic Alignment and Adjusted Mechanical Alignment With Robotic-assisted Unilateral Total Knee Arthroplasty.Thammasat University · Updated 19 Feb 2025
FDA record
48 FDA records
Clearances and recalls from the FDA's own database.
- 510(k) clearanceMako Total Knee Application25 Feb 2026 · K260222
- 510(k) clearanceMako Total Knee Application (3.0); Hybrid Tip Pointer25 April 2025 · K250608
- 510(k) clearanceMako Total Hip Application 5.05 March 2025 · K243751
- 510(k) clearanceMako Shoulder Application (1.0)7 Nov 2024 · K242373
- 510(k) clearanceQ Guidance System; Mako Spine System;27 Aug 2024 · K241517
- RecallMAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 2090637 Aug 2024
- 510(k) clearanceMako Total Knee Application11 June 2024 · K241011
- RecallTotal Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.0.0.1 + PKA 3.0.2 Application Part…15 April 2024
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: Stryker said Mako was installed in 35 countries and had been used in more than 1 million operations (6 July 2023).
- 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. We could not confirm Mako's spine and shoulder uses, its FDA clearance numbers, or any recalls: the shared search budget ran out before this card. All facts here come from Stryker's own newsroom. In October 2026 Stryker also agreed to invest in CMR Surgical (see Versius).
Sources
- 01Stryker news release, 9 Feb 2026
- 02Stryker news release, 16 July 2026
- 03Stryker feature, 6 July 2023
Cite this page
Robotics Verdict. “Mako (Stryker): how far has it got?” roboticsverdict.com/robots/stryker-mako. Checked 19 October 2026.
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