Prophecy Surgical Planning System
Wright Medical Technology, Inc (Stryker)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.
Intended Use
The Prophecy Surgical Planning System is intended to be used as patient-specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively, in guiding the marking of bone before cutting, and in the pre-surgical planning of the ankle and surrounding anatomy to support the total ankle implant.
Technology
The system comprises three components: patient-specific surgical guides, a web-based 3D planning software (Prophecy 3D Planner), and patient-specific preoperative reports derived from CT and X-ray imaging scans. It uses image segmentation and converts DICOM medical imaging data into 3D models, enabling surgeons and engineers to plan implant alignment, size, and positioning, and produces 3D printed guides via additive manufacturing for surgical use. The updated software version replaces previous off-the-shelf software and integrates landmark placement, implant alignment, sizing, and guide design functionalities.
Performance
The device was supported by non-clinical in-house testing including software verification and validation, usability testing, and cybersecurity testing. All tests met acceptance criteria, demonstrating safety and effectiveness equivalent to predicate devices. Clinical testing was not required for substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/9/2024
3 months - 2
FDA Approval
11/1/2024
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.