Paradigm System

The Paradigm System is a stereotaxic image guidance system used during open spine surgery to position and orient surgical instruments. It combines real-time camera imaging of the surgical site with preoperative CT data and surgical navigation to guide pedicle screw placement from thoracic to sacral vertebrae using a posterior approach.

The subject and predicate devices are technically identical: both use preoperative CT segmentation to generate 3D spine models, perform intraoperative registration of patient anatomy using reflective markers on instruments, and overlay virtual guidance on live anatomy. Both use the same components (cart, arm, sensor array, external monitor, surgical instruments, software), same energy source (120V), same sterilization methods (steam for instruments, ethylene oxide for drapes), and same minimum sterility assurance level (1×10⁻⁶).

Testing followed IEC 62366-1, ISO 10993-1, ISO 14971, ISO 17665-1, ANSI/AAMI ST79, ASTM F2554-22, ANSI/AAMI ST98, and IEC 62304. These standards address usability engineering, biocompatibility, risk management, steam sterilization validation, positional accuracy of surgical systems, and software lifecycle processes.

The subject device demonstrates substantial equivalence because it has identical intended use, indications for use, and fundamental scientific technology as the predicate (K243258). Both devices perform the same stereotaxic surgical navigation function with the same components, instruments, energy source, and sterilization methods. Verification and validation testing—including non-clinical tests, design validation, and compliance assessments—confirms that the devices pose no new risks of safety or effectiveness, establishing that any differences do not raise new safety or effectiveness concerns.