Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories

Spine Guidance 5.3 Software is a computer-assisted surgical guidance system for orthopedic and neurological spine procedures in adults and adolescents. It enables planning and real-time intraoperative navigation for screw placement, bone resection, and interbody cage placement in the lumbar spine. The Q Interbody Instruments are surgical tools designed to facilitate preparation and placement of spinal implants using the guidance system.

The software adds new features for interbody cage placement visualization, including integration of three VB Spine cage families and support for navigated interbody instruments. It maintains the same core operating modes (planning, registration, navigation), imaging modalities (CT, MR, PET), system accuracy (2 mm positional, 2° angular), and infrared optical tracking as the Spine Guidance 5.2 predicate. Q Interbody Instruments are substantially equivalent to Q Pedicle Instruments in design, materials, and fundamental technology.

IEC 62304 software validation, ASTM F2554-22 system accuracy verification, ISO 10993-1:2018 biocompatibility, ISO 17665-1 sterilization validation, IEC 60601-1:2005 and IEC 60601-1-2:2014 electrical safety and electromagnetic compatibility standards, and FDA Guidance on General Principles of Software Validation.

The subject devices are substantially equivalent because they perform the same intended function with equivalent design, materials, and operation principles as their predicates. Verification and validation testing confirmed no new or different questions of safety or effectiveness were raised. The Spine Guidance 5.3 adds interbody functionality but maintains predicate system accuracy and core architecture; the Q Interbody Instruments are substantially equivalent to Q Pedicle Instruments in fundamental design.