Dynamis Robotic Surgical System

The Dynamis Robotic Surgical System is a navigation-based robotic platform with real-time tracking for spine surgery. It aids surgeons in precisely locating anatomical structures and positioning instruments for placement of non-cervical spinal pedicle screws in open or percutaneous procedures, requiring intraoperative CT imaging with identifiable fiducial markers.

Dynamis uses two robotic arms for surgical guidance plus a third arm holding an optical camera, with an adjustable end effector (Dynacan) supporting instrument diameters from 3–20 mm. Unlike the predicate EXCELSIUS GPS's fixed-diameter guide tube and proprietary instrument sets, Dynamis uses 'qualified' non-proprietary instruments verified through an integrated Instrument Setup test. Both systems employ optical markers for navigation, force-controlled foot pedal/squeeze bracelet control, and DICOM compatibility; Dynamis integrates all components into a single cart whereas EXCELSIUS uses two separate carts.

ASTM F2554-22 (navigation accuracy), IEC 62304 and IEEE/ISO/IEC 29119-1-2-3-5-2021 (software verification/validation), IEC 62304:2006/AMD 1:2015 and IEC 81001-5-1:2021 (cybersecurity), IEC 60601 series (electromagnetic and electrical safety), ISO 10993 series (biocompatibility), ANSI/AAMI ISO 17665-1 and AAMI standards (cleaning and sterilization), and ANSI AAMI IEC 62366-1:2015 (human factors/usability).

Both devices are Class II stereotaxic instruments (21 CFR 882.4560) intended for robotic-guided spinal pedicle screw placement using optical navigation and real-time imaging. They share the same indications for use, regulatory classification, and core functional principles: optical marker-based patient registration, force-controlled robotic guidance, and freehand/robotic surgical workflows. The key differences—adjustable vs. fixed end effector, qualified vs. proprietary instruments, single vs. dual carts, and imaging modality (3D intraoperative vs. 3D preoperative/2D intraoperative)—do not introduce new safety or efficacy concerns because the navigation accuracy and system-level performance were validated to demonstrate equivalent or superior accuracy in clinically relevant models.