Mako Total Hip Application 5.0

The Mako Total Hip Application 5.0 is a stereotactic surgical system that assists surgeons during total hip arthroplasty procedures by providing software-defined spatial boundaries for implant orientation and positioning using patient CT data. The system includes a robotic arm with integrated cutting instruments, optical navigation, and preoperative planning software to guide bone preparation and implant placement, including revision procedures where the acetabular component can be replaced with a cup or cup-and-wedge construct.

The subject device integrates the Mako Total Hip Application software with the updated Mako 4 hardware platform (Q-Guidance System) rather than the older hardware in the predicate. New software features include screw planning and trajectory guidance, augment planning and preparation, pelvic registration for revision cases, bone mapping, and pre/post-impaction clocking. The robotic arm software (CRISIS), navigation software (MGo), and Treatment Design Application (TDA) were updated for compatibility with the new Flex OS operating system.

Not stated in this summary.

The subject device shares the same fundamental intended use, design principles, and technological approach as the predicate—both assist surgeons with CT-guided robotic-assisted total hip replacement using software-defined spatial boundaries. Although integrated with newer Mako 4 hardware and enhanced with additional planning features for revision cases, the modifications do not alter the core function or clinical purpose. Performance testing including software verification, bone registration and resection accuracy, system validation, and cadaveric surgeon studies demonstrated equivalent safety and effectiveness characteristics, supporting the determination that the device does not raise different questions of safety or effectiveness.