Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II

The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II are image-guided surgical systems for precise positioning of surgical instruments and spinal implants during spine surgery. The devices register intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery to guide open or percutaneous procedures, with example applications including posterior-approach pedicle screw placement in the lumbar region.

The subject devices incorporate new Image calibrator modules (Image calibrator-21F and Image calibrator-31F) designed to be compatible with 21 cm and 31 cm flat panel C-arm systems for CT image position and calibration. The system software has been upgraded and includes a new auto-labeling function for CT/C-arm image registration. Despite these modifications, the devices maintain the same intended use, indications, fundamental technology, and overall design as the predicate devices.

Software verification and validation were performed in accordance with FDA guidance for premarket submissions of software in medical devices and IEC 62304. Risk assessment was conducted per ISO 14971. Design verification employed the same test methods as the previously cleared predicate device K233513.

The subject devices share identical intended use and fundamental technology with predicate devices K230783 and K233513, differing only in software version upgrades and new compatible image calibrator modules. Since the intended use and core technology are identical, the same testing methods from the predicate were applied, and all results passed. The software upgrades and calibrator additions do not introduce new safety or effectiveness issues because they maintain the same underlying function and operational principles as the cleared predicate devices.