United Orthopedic Knee Patient Specific Instrumentation
Enhatch, Inc.The United Orthopedic Knee Patient Specific Instrumentation by Enhatch, Inc. is a system that uses AI-powered software to process CT and X-ray images for 3D modeling and preoperative surgical planning of total knee arthroplasty. It includes patient-specific surgical guides to help orthopedic surgeons accurately position knee implants during surgery, improving precision and outcomes for patients without severe bone deformities.
Intended Use
Orthopedic instrument system to assist in the positioning of compatible total knee arthroplasty systems using preoperative planning software processing CT and X-ray images and patient specific surgical guides.
Technology
System composed of software and hardware: Intelligent Surgery Knee CT and X-ray Segmentation Engines using deep learning for segmentation and 3D modeling, Implant Recognition Engine using optimization algorithms for implant sizing and positioning, and patient-specific surgical guides manufactured based on the surgical plan.
Performance
Performance tested through multiple verification and validation studies including segmentation accuracy, 3D model accuracy, landmark detection, guide wear testing, and system use simulations on cadaver specimens. All tests demonstrated satisfactory performance consistent with intended use and predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/28/2023
8 months - 2
FDA Approval
12/20/2023
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