Intended Use

Precise positioning of surgical instruments or spinal implants during general spine surgery using intraoperative 2D fluoroscopic and preoperative 3D CT image registration for planning and guidance.

Technology

The devices use upgraded system software and new Image calibrators compatible with 21 cm/31 cm flat panel C-arms for CT image positioning and calibration. They operate by image registration of intraoperative 2D fluoroscopic projections to preoperative 3D CT images to enable navigated spine surgery.

Performance

Verification and validation confirm the software meets FDA guidance and IEC 62304 standards. Risk controls are verified per ISO 14971. Design verification matched that of the predicate devices. All tests passed, demonstrating performance as safe and effective as predicates.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    4/29/2025

    1 month
  • 2

    FDA Approval

    5/29/2025

Other devices from Remex Medical Corp.

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