Paradigm System
Proprio, Inc.The Paradigm System by Proprio, Inc. is a surgical navigation system that helps surgeons precisely position spinal instruments during posterior spine surgeries. It combines preoperative CT-based 3D models of the spine with real-time camera imaging of the surgical site to enable accurate instrument placement, improving surgical accuracy and patient outcomes.
Intended Use
The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. It is indicated for posterior approach spine surgery referencing CT-derived patient images for pedicle screw cannulation of thoracic to sacrum vertebrae.
Technology
The device fuses high-resolution, real-time camera imaging of the surgical site with preoperative CT medical imagery and surgical navigation data. It uses a Prism Sensor Array to intraoperatively register the live topography of the patient's exposed spine to the preoperative 3D model, creating a common coordinate space for accurate instrument placement.
Performance
Verification and validation testing including non-clinical verification, design validation, and compliance conformity assessments were performed. The system adheres to relevant standards such as IEC 62366-1, ISO 10993-1, ISO 14971, ASTM F2554-22, IEC 62304, and others to ensure safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/24/2025
2 months - 2
FDA Approval
6/4/2025
Other devices from Proprio, Inc.
- Paradigm System2025 • 510K
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