CORIOGRAPH Pre-Op Planning and Modeling Services
Blue Belt Technologies, Inc.CORIOGRAPH Pre-Op Planning and Modeling Services is a software tool used for preoperative planning of orthopedic surgeries such as unicondylar knee replacement, total knee arthroplasty, and primary total hip arthroplasty. It generates patient-specific bone models and surgical plans based on medical imaging scans, helping surgeons plan and optimize implant placement before surgery.
Intended Use
CORIOGRAPH Pre-Op Planning and Modeling Services are intended to provide preoperative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for generating the plan are identifiable on patient imaging scans.
Technology
The device includes CORIOGRAPH Hip Pre-Op Plan and CORIOGRAPH Modeler modules that utilize patient imaging scans, primarily CT for hips, to generate patient-specific bone models and preoperative surgical plans. It combines these plans with implant positioning simulations. Plan generation involves medical personnel and software-based modeling, which is viewed and editable via the CORIOGRAPH Modeler software.
Performance
Verification and validation testing demonstrated safety and effectiveness. Summative usability testing showed surgeons could safely and effectively use the device in simulated conditions. Kinematic models and activities of daily living included are clinically relevant. All design inputs were met without raising safety or effectiveness concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/1/2024
3 months - 2
FDA Approval
11/15/2024
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