Paradigm System
Proprio, Inc.The Paradigm System is a surgical navigation device that helps surgeons accurately place spinal surgical instruments during open procedures. It integrates real-time high-resolution camera images of the surgical site with preoperative CT imagery to create a 3D model of the spine, enabling precise instrument placement and improving surgical accuracy and safety from thoracic to sacrum vertebrae.
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. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae.
Technology
Paradigm System fuses high-resolution, real-time camera imaging of the surgical site with CT medical imagery and surgical navigation data to enable precise instrument placement. It generates a 3D model of the patient's vertebrae from preoperative CT data, performs preoperative planning, and intraoperatively registers live anatomy to the CT model for real-time guidance.
Performance
Verification and validation testing included hardware, software, and instrumentation tests, non-clinical design validation in cadaveric models, and compliance with multiple IEC and ISO standards to ensure safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/15/2024
4 months - 2
FDA Approval
2/21/2025
Other devices from Proprio, Inc.
- Paradigm System2025 • 510K
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