Stealth™ Spine Clamps; ModuLeX™ Shank Mounts

The Stealth™ Spine Clamps and ModuLeX™ Shank Mounts are stereotaxic instruments that provide rigid fixation between a patient and a patient reference frame during computer-assisted spinal surgery using the Stealth™ System. These reusable, steam-sterilizable devices are designed for skeletally mature patients and enable navigation-guided surgical procedures for various spinal conditions.

Both subject devices utilize the same fundamental scientific technology and mode of operation as their respective predicates. The Stealth™ Spine Clamps are available in straight (short, medium, tall), double (medium), and angled (short, medium) configurations using materials including titanium alloys and stainless steel variants. The ModuLeX™ Shank Mounts attach to the CD Horizon™ ModuLeX™ spinal implant system using similar materials. Both devices maintain equivalent sterilization methods and patient fixation approaches to their predicates.

ISO 10993-1 was cited as the basis for biological evaluation and biocompatibility testing, including assessments of cytotoxicity, sensitization, irritation, toxicity, and pyrogenicity.

The subject devices are substantially equivalent because they employ identical fundamental scientific principles and modes of operation as their predicates while maintaining equivalent intended uses and sterilization/reprocessing methods. Although the subject devices feature expanded material options (e.g., titanium with Type II anodize, Nitronic 60 for Spine Clamps; 465 stainless steel variants for Shank Mounts), these material additions do not introduce new safety risks. Performance testing—including mechanical robustness, navigation accuracy, functional verification, and biocompatibility—demonstrates the devices pose no new concerns regarding safety and effectiveness.