FDA Radiology AI Devices

The Prophecy Surgical Planning System is a patient-specific surgical planning tool designed to aid orthopedic surgeons in total ankle replacement surgeries. It leverages medical imaging data from CT scans and X-rays to create customized 3D planning reports and guides that assist in the precise positioning and alignment of ankle implant components during surgery, improving surgical accuracy and patient outcomes.

The Blueprint Patient-Specific Instrumentation system by Stryker Corporation includes hardware and software components designed to assist surgeons in planning and performing shoulder replacement surgeries, specifically reversed shoulder arthroplasty. It uses CT scans to generate patient-specific surgical guides and implants, improving the precision of implant placement and potentially leading to better surgical outcomes for patients with shoulder joint conditions.

The Precision AI Surgical Planning System (PAI-SPS) is a software and hardware system designed to assist surgeons in preoperative planning and intraoperative guidance for shoulder replacement surgeries. It creates a 3D model of the patient's shoulder joint from CT scans, allowing surgeons to visualize and plan implant placement precisely. Custom surgical guides are also produced to help accurately position shoulder implant components during surgery, enhancing surgical outcomes.

ARVIS® Shoulder is a computer-assisted surgical navigation system designed to help surgeons precisely position and align implants during total shoulder arthroplasty. It uses preoperative CT scans processed with AI algorithms for automatic image segmentation and anatomical landmark identification, providing real-time measurements during surgery to guide instrument placement and implant positioning, thereby enhancing surgical accuracy and outcomes.

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.