Paradigm System

The Paradigm System is a stereotaxic image guidance system for spinal surgery that combines real-time camera imaging of the surgical site with preoperative CT data and navigation information to guide precise placement of surgical instruments. It is indicated for posterior approach spine surgery to assist with pedicle screw placement from the thoracic to sacrum vertebrae.

The subject device adds a foot switch component and changes the point cloud visualization color from green to blue. Registration can now be initialized by either point matching on the vertebra or by tracing vertebral landmarks of exposed bone, whereas the predicate only supported point matching. All other technical specifications including the stereotaxic guidance mechanism, preoperative 3D model generation, and intraoperative registration remain functionally identical.

IEC 60601-1:2005 (medical electrical equipment safety), IEC 60601-1-2:2014 (electromagnetic compatibility), IEC TS 60601-4-2:2024 (electromagnetic immunity), IEC 60601-1-6:2010 (usability), IEC 60825-1:2014 (laser safety), IEC 62366-1:2015 (usability engineering), ISO 14971:2019 (risk management), and IEC 62304:2015 (software lifecycle).

The subject device has the same indications for use, intended use, fundamental scientific technology, and functional operation as the predicate Paradigm System (K250879). The minor differences—addition of a foot switch, alternative registration method, and visualization color change—do not raise new safety or effectiveness risks as demonstrated by verification and validation testing in cadaveric models and compliance assessments.