Model note · Surgical Robot
Mako SmartRobotics System
Mako is Stryker's robotic arm system for orthopaedic joint replacement. A CT based model of the patient's bone is used to plan the implant, and during surgery the robotic arm holds the saw or burr and stops it at software defined boundaries. One platform runs separate knee, hip, partial knee and spine applications, and it is one of the most widely used orthopaedic robots, so biomedical teams meet it in many theatre suites.
The model
Maker, model and type.
- Maker
- Mako Surgical Corp. (Stryker)
- Model
- Mako SmartRobotics System (Mako 3.0 / 3.1 platform with Total Knee, Total Hip and Partial Knee applications)
- Device type
- Surgical Robot
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| FDA classification | Stereotaxic instrument, 21 CFR 882.4560, Class II, product code OLO | Source |
| Recent clearance | K250608, Mako Total Knee Application 3.0 with a battery powered Hybrid Tip Pointer, decided 25 April 2025 | Source |
| Main system components | Robotic arm, integrated cutting system, optical detector, camera, computer, instrumentation, operating software, tools and accessories | Source |
| Imaging input | Patient CT data used for pre surgical planning and intraoperative navigation | Source |
| Tracking hardware | Stryker Q Guidance System, which replaced the earlier Mako camera stand and guidance module | Source |
| Compatible knee implants (TKA application) | Triathlon Total Knee System, CR, CS, PS and PSR cemented and cementless primary, and TS inserts cemented primary | Source |
| Platform part numbers named by FDA | Mako 3.0 part number 209999; Mako 3.1 part number 219999 | Source |
| Integrated cutting system handpiece | Mako Integrated Cutting System (MICS) handpiece, catalogue number 209063, attached to the distal end of the arm | Source |
| Applications on one system | Total knee, total hip, partial knee and spine; Mako 4 is the fourth generation | Source |
| Installed experience (manufacturer claim) | More than 2 million procedures in 45 countries over 19 years | Source |
Recalls
Known FDA recalls.
- Z-0044-20252024-08-07
Characterisation process issue affected constant values assigned to MICS handpieces.
FDA record - Z-1910-20242024-04-15
More frequent Software Error 3 when switching applications without a restart on Mako 3.0 and 3.1, delaying treatment.
FDA record - Z-1735-20222022-08-08
USB converter for the Polaris Spectra camera could arrive non functional, fail, or flash an error light.
FDA record - Z-0472-20212020-10-23
MICS handpiece characterisation issue could cause unsuccessful saw blade checkpoint verification.
FDA record - Z-2745-20202020-07-09
Variable angle hip end effector characterisation issue could cause a bone preparation discrepancy.
FDA record - Z-2924-20182018-07-24
Damaged reflective material on Vizadisc knee tracking kits could prevent camera detection.
FDA record - Z-0385-20132012-09-12
RIO software 2.4 replaced by 2.5 after reported loss of tactile feedback on the cutting burr.
FDA record
Safety
Safety warnings from the record.
- An older software release (RIO 2.4) was recalled after loss of tactile feedback constraining the cutting burr was reported, which shows why software level matters on this platform. Source
- A handpiece characterisation fault can stop the system verifying blade position before bone preparation, delaying surgery. Source
- On the older RIO system a loose screw in the internal cPCI card cage could cause intermittent loss of system power. Source
Sources
Where this note comes from.
- Stryker Mako SmartRobotics page (US)
- FDA 510(k) K250608 summary, Mako Total Knee Application
- FDA 510(k) K241011 summary, Mako Total Knee Application with Q Guidance System
- openFDA recall search, Mako
- openFDA MAUDE problem counts, brand Mako
Not covered: Stryker does not publish the Mako service manual, a full error code list, electrical ratings or accuracy figures for the current platform; the only error code listed comes from an FDA recall record. The 510(k) summaries list accuracy tests but not numeric results. Mako 4 hardware details were not found in a public FDA summary. MAUDE counts mix all Mako products and are not a failure rate. Several older RIO era recalls and implant trial recalls are left out.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Surgical Robot