mBôs (Monogram mBôs TKA System)

The mBôs TKA System is a stereotactic surgical planning and implementation device designed to assist orthopedic surgeons in performing total knee arthroplasty (TKA) procedures on adults. It uses robotic assistance to enable precise bone cutting and implant placement based on CT-derived anatomical models, serving as an alternative to manual template-based planning.

The system comprises a robotic arm mounted on a stabilized cart with integrated sagittal saw-based cutting mechanism, infrared optical tracking, display screen, foot pedal, touchscreen, and proprietary software suite (mSuite). Key differences from the predicate include the subject device's robot-suspended End Effector (vs. predicate's MICS Handpiece) and differences in how resection planes are established, though both employ similar hardware configurations with IR tracking, computer units, and dedicated instrumentation.

ISO 14971:2019 (risk management), Cadaveric Cut Accuracy testing, System End-to-End Accuracy testing, Robot Arm Positional Accuracy testing, Cutting Tool Positional Accuracy testing, Registration Accuracy testing, Hardware Reliability testing, Positional Repeatability testing, Blade Cut-Path Verification, and Soft Tissue Assessment Validation.

Both the subject and predicate devices are stereotactic computer-assisted systems for TKA that track bone structures relative to CT-based models and utilize robot-mounted cutting instruments controlled via foot pedal navigation. Despite minor differences in End Effector design and resection plane establishment, testing demonstrated substantially equivalent performance in cutting accuracy, navigation feedback, implant positioning, surgical workflows, and clinical outcomes on synthetic and cadaveric specimens, confirming equivalent intended use and technological principles.