Arthrex Virtual Implant Positioning (VIP) System Software
Arthrex, Inc.The Arthrex Virtual Implant Positioning (VIP) System Software is a medical software tool designed to assist surgeons in preoperative planning and precise placement of implants for total shoulder replacement. It processes and displays CT imaging data to help plan and adjust implant positioning, enhancing surgical accuracy and patient outcomes.
Intended Use
The VIP Web Portal is intended for use as a software interface and for the transfer of imaging information from a medical scanner such as a CT scanner. It is also intended as software for displaying/editing implant placement and surgical treatment options generated by trained technicians. The OrthoVis Preoperative Plan facilitates accurate preoperative planning and intraoperative placement of glenoid and humeral components in total shoulder replacement.
Technology
The system comprises two main components: a web-based VIP Web Portal for uploading, viewing, and editing medical images and preoperative plans, and the OrthoVis Preoperative Plan software which creates plans for shoulder implant placement. The software supports modifying implant type, size, location, and orientation, and communicates plans between surgeons and technicians. New features include Range of Motion, Osteophyte Removal, Multiple Plan creation, and updated user interface.
Performance
Software verification and validation were performed, including validation/verification testing, regression testing, unit testing, code review, and integration testing following FDA guidance for device software functions.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/22/2024
5 months - 2
FDA Approval
10/2/2024
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