Remex Spine Surgery Navigation Instrument

The Remex Spine Surgery Navigation Instrument is a set of surgical tools (Nav Awl, Nav Drill Guide, Nav Tap, Nav Screwdriver, and Nav Handle) designed to work with two navigation systems to assist surgeons in precisely positioning surgical instruments and spinal implants during spine surgery. It uses intraoperative fluoroscopic imaging registered to preoperative CT scans to guide posterior-approach procedures such as pedicle screw placement in the lumbar spine.

The subject device has the same intended use, indications, sterilization method, fundamental technology, and similar materials and design as the predicate devices. The key differences are an upgraded system software version and new instruments designed for compatibility with the predicate systems, though these modifications share the same function and fundamental technology.

Software verification and validation per FDA guidance and IEC 62304; risk assessment per ISO 14971; design verification through design input/output fulfillment; biocompatibility evaluation per FDA guidance and ISO 10993-1.

The device shares identical intended use and indications with its predicates (K233513 and K230783), uses the same sterilization method and fundamental navigation technology, and is composed of similar materials. Although the device includes software upgrades and new instruments, these modifications do not introduce new safety or effectiveness concerns because they maintain the same core function and technology. All testing demonstrates equivalent safety and effectiveness to the predicate devices.