Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor

The Spine Guidance 5.4 Software is a computer-assisted surgical guidance system that helps surgeons plan and perform orthopedic and neurological spine procedures. It uses imaging and optical tracking to guide instrument placement for screw placement, bone resection, and interbody device placement in adult and pediatric patients.

The Spine Guidance 5.4 Software maintains the same indications for use, main system components (Q Guidance System, Mako Spine System), modes of operation, planning/navigation features, localizing technology (infrared optical active/passive tracking), system accuracy (2 mm positional, 2° trajectory), and supported imaging modalities as the predicate Spine Guidance 5.3 Software. New integrations include the Q Drill Tracker component, ability to navigate the Maestro Air Motor, additional burs, and expanded NavLock Adapter compatibility.

Software testing per IEC 62304 and FDA Guidance on General Principles of Software Validation; system accuracy per ASTM F2554-22; biocompatibility per ISO 10993-1:2018; sterilization validation per ISO 17665-1 (reusable) and ISO 11137-2 (single-use); electrical safety and electromagnetic compatibility per IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020, and IEC 60601-1-2:2014.

The subject devices are substantially equivalent because they maintain the same intended use, design principles, operating principles, technology (infrared optical tracking), materials, and performance as their respective predicates, with no changes to fundamental scientific technology. The Spine Guidance 5.4 Software integrates new compatible components but does not alter core functionality; the Maestro Air Motor, Elite Q Attachments, and Elite Cutting Accessories have no design or material changes, only updated indications reflecting use with the new software version. Performance testing and cadaver validation confirmed all requirements were met with no new safety or effectiveness issues raised.