Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II
Remex Medical Corp.The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II are surgical navigation tools that use fluoroscopic 2D and CT 3D imaging to precisely guide the placement of surgical instruments and implants during spine surgery. By registering images intraoperatively, they help surgeons perform accurate and safe spinal implant procedures, such as lumbar pedicle screw placement, improving surgical outcomes.
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.
- Remex Spine Surgery Navigation Instrument2024 • 510K
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