Mako Total Knee Application (3.0); Hybrid Tip Pointer

The Mako Total Knee Application (3.0) is a robotic surgical system that assists surgeons during total knee arthroplasty procedures. It uses CT imaging and software-defined spatial boundaries to provide haptic guidance and help surgeons position knee implants accurately. The system includes a robotic arm, optical tracking, cutting tools, and planning software to guide bone preparation relative to the patient's anatomy.

The subject device has identical major components (robotic arm, Stryker Q Guidance System, cutting system), tools/accessories, and CT-based imaging compared to the predicate. The modifications include a new battery-powered active pointer for registration and landmark selection, updated programming language for the software, enhanced user interface, additional optional planning features, and improved overall user experience.

Not stated in this summary.

The subject device performs the same intended use (knee arthroplasty guidance with software-defined spatial boundaries) as the predicate device cleared in K241011. Despite software modernization and the addition of a new active pointer tool, the core hardware architecture, imaging modality, and fundamental technology remain unchanged. Performance testing including bone registration/resection accuracy, cadaveric validation, EMC safety, software functional testing, and instrumentation assessment all demonstrate equivalent characteristics to the predicate, establishing that the modifications do not raise different safety or effectiveness questions.