Spine & Trauma Navigation Instruments

The Spine & Trauma Navigation Instruments system is an intraoperative image-guided surgery system that uses optical tracking to link a freehand probe to preoperative or intraoperative 2D/3D medical images. It enables open and minimally invasive spine and trauma surgery with computer-assisted navigation, screw and interbody device planning, and is indicated for any condition where stereotactic surgery is appropriate with a rigid anatomical reference structure.

The subject device maintains identical navigation accuracy (mean positional error ≤2 mm, mean angular error ≤2°) and optical tracking technology as the predicate. Key differences include: a new Patient Reference Rod-Clamp enabling attachment to existing rods (versus direct bone fixation in predicate); replacement of X-Clamps with new Patient Reference Steel-Clamps offering improved stiffness; reclassification of Sterilization Trays from Class I to Class II; and introduction of two new Sterilization Tray variants.

ISO 10993-1:2018 (biocompatibility evaluation for tissue and blood contact <24 hours); ISO 17664-1 (worst-case reprocessing validation for cleaning, disinfection, and steam sterilization). Mechanical stability, fixation stability under static and dynamic loads, reprocessing validation, biocompatibility, and formative usability testing were performed.

The subject device performs the same intended function with identical indications and navigation accuracy as predicate K221618. Although the Patient Reference Rod-Clamp introduces a novel attachment mechanism (hook-clamp to rod versus bone pins), testing demonstrated equal or better fixation stability than predecessor clamps. The replacement steel clamps use the same bone-fixation concept and materials (stainless steel, PEEK) as predicate clamps. Sterilization Trays remain based on the same generic supplier concept with only classification and variant changes. No new risks emerged from biocompatibility or reprocessing validation, supporting substantial equivalence.