CORIOGRAPH Pre-Op Planning and Modeling Services
Blue Belt Technologies, Inc.CORIOGRAPH Pre-Op Planning and Modeling Services is software designed to assist surgeons with preoperative planning for orthopedic surgeries such as knee, hip, and shoulder replacements. It uses patient imaging scans to create personalized surgical plans and allows surgeons to simulate and modify implant positioning before surgery, helping improve precision and surgical outcomes.
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
CORIOGRAPH is a software medical device system comprised of multiple modules, including Pre-Op Plan modules that generate initial alignment recommendations from patient imaging and implant geometry, and Modeler modules that allow surgeons to modify and evaluate the plan using impingement analysis tools such as Range-of-Motion (ROM) and Activities of Daily Living (ADL) simulations. It supports input from various imaging modalities and surgeon preferences.
Performance
Verification and validation testing demonstrated the system meets design requirements and is as safe and effective as predicate devices. Software testing followed IEC 62304, usability testing confirmed safe and effective use by surgeons, and credibility evaluation showed clinical relevance of kinematic and ADL models.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/27/2025
3 months - 2
FDA Approval
6/25/2025
Other devices from Blue Belt Technologies, Inc.
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