MySpine WebPlanner
Medacta International S.A.MySpine WebPlanner is a web-based surgical preoperative planning software that assists orthopedic and neurosurgeons by allowing them to view, store, measure radiological images, and plan surgical placement of spinal fixation and fusion devices. It supports surgeons in preparing surgical plans by providing detailed imaging and implant positioning information, helping improve clinical decision-making before spinal surgery.
Intended Use
The MySpine WebPlanner software is designed to be used by a competent person who will generate a preoperative plan that may give relevant information to an authorized orthopedic or neurosurgeon before spinal posterior fixation surgery. The software assists in viewing, storing, measuring radiological images, and planning surgical placement of spinal fixation and fusion devices in skeletally mature and immature individuals to support preliminary decisions on implant size and positioning.
Technology
Interactive web application that uses patient's radiological DICOM images and related bone segmentations. Data displayed via the web interface are computed and loaded by an internal software named MyPlanner. The application workflow includes quality control, 3D bone model segmentation, surgical planning, validation, and generating a planning report. It supports cage planning addition to previous capabilities.
Performance
Software verification and validation studies were performed to support safety and effectiveness, especially addressing the introduction of the new cage planning module.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/29/2024
4 months - 2
FDA Approval
4/23/2025
Other devices from Medacta International S.A.
- NextAR(TM) Spine2025 • 510K
- MyShoulder Planner (5.3SSWPL)2025 • 510K
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