Remex Spine Surgery Navigation - Universal Instruments
Remex Medical Corp.The Remex Spine Surgery Navigation - Universal Instruments is a system accessory that helps surgeons accurately track and guide surgical instruments during spine procedures using CT and fluoroscopic images. It offers enhanced precision for placing spinal implants or instruments, supporting both planning and intraoperative navigation to improve outcomes for spine surgery patients.
Intended Use
Accessory instruments for the Remex Spine Surgery Navigation System II, supporting instrument tracking during spine surgery, including posterior-approach spinal implant procedures such as pedicle screw placement in the lumbar region. Enables image-guided surgery by registering fluoroscopic projections to CT imagery.
Technology
The device is an accessory set of newly added navigation instruments for the Remex Spine Surgery Navigation System II. It expands compatible instruments (e.g., calibration block, NavGuide handles, needle, adapters) and supports them through software updates. The accessory operates with the navigation system to enable real-time registration of intraoperative 2D fluoroscopy with pre-op 3D CT images for instrument tracking and guidance. The software and fundamental navigation workflow remain unchanged.
Performance
Comprehensive verification and validation testing was conducted, including software validation per FDA/IEC62304, risk assessment (ISO 14971), design verification, positional and navigational accuracy testing (ASTM F2554-22, navigational accuracy acceptance <2mm and <2°), and biological evaluation (ISO 10993-1:2018). All acceptance criteria were met, demonstrating the device is as safe and effective as the predicate devices.
Predicate Devices
No predicate devices specified
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