Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)

The Valence Robotic Navigation System is an image-guided surgical system for assisting surgeons in placing pedicle screws and interbody implants in spinal procedures. It uses optical instrument tracking and registration to intraoperative 3D scans to enable robotic-assisted, freehand screw navigation, and disc preparation workflows. Select instruments are also compatible with the Medtronic StealthStation surgical navigation system.

The system comprises a computer workstation, software, trajectory system with targeting platform, camera, and image-guided instruments. It uses optical instrument tracking and registration to 3D imaging scans across three independent workflows. The Valence instruments for StealthStation use are dimensionally comparable to Medtronic instruments with similar design and function.

Not stated in this summary. The document references ISO 13485 clauses 7.3 and 8.5 and ISO 13484 clause 8.3 for quality management system requirements, but does not cite specific performance test standards such as ISO, IEC, or ASTM standards.

The Valence Robotic Navigation System is substantially equivalent to the primary predicate Fusion Robotic Navigation System (K232413) based on similar intended use, indications, design, function, and technology. Additional equivalence is claimed to Medtronic Navigated Manual Reusable Instruments (K161210) and ATEC Posterior Navigated Disc Prep Instruments (K232345). Nonclinical testing including software/hardware verification, accuracy testing, dimensional analysis, and simulated cadaveric use testing demonstrated that any technological differences do not impact safety and effectiveness.