Mako Surgical Corp. · Class II · Cleared Feb 25, 2026
| K-number | K260222 |
| Device name | Mako Total Knee Application |
| Applicant | Mako Surgical Corp. |
| Product code | OLO |
| Device class | Class II |
| Decision date | Feb 25, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 882.4560 |
The Mako Total Knee Application is a stereotactic surgical system that assists surgeons during total knee arthroplasty (TKA) by providing software-defined spatial boundaries for anatomical orientation and reference. It uses patient CT data for pre-surgical planning, implant placement, and intraoperative navigation, with a robotic arm serving as an intelligent tool holder to constrain surgical preparation within defined boundaries.
The subject device has identical major components, tools/accessories, and imaging methodology as the predicate: robotic arm, Stryker Q Guidance System, cutting system, various reusable and disposable instruments, and CT-based imaging. The modification only adds compatibility with the Triathlon X3 Medial Stabilized Tibial Bearing Insert without altering design, materials, or principles of operation.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov