Medyssey Navigation System
Medyssey Co, Ltd.The Medyssey Navigation System is a reusable surgical instrument set designed to work with the Medtronic StealthStation navigation system. It helps surgeons precisely locate anatomical structures during spinal surgeries by integrating with imaging data such as CT or MR-based models, fluoroscopy images, or digitized landmarks. This improves accuracy in placing spinal fixation implants and supports open or minimally invasive procedures.
Intended Use
Indicated for use during preparation and placement of Medyssey screws during spinal surgery to assist in precisely locating anatomical structures using stereotactic methods in open or minimally invasive procedures.
Technology
Reusable instruments including bone taps and screwdrivers made of medical grade stainless steel, designed to be used with the Medtronic StealthStation navigation system and NavLock arrays. Provides stereotactic assistance by referencing CT or MR based models, fluoroscopy images, or digitized anatomical landmarks for accurate surgical navigation in spinal procedures.
Performance
Comparative dimensional analysis verified accuracy, functionality, and compatibility with the Medtronic StealthStation System. Reprocessing validations for cleaning and sterilization followed ANSI/AAMI ST98 and ISO 17665 standards. Biocompatibility data leveraged from related predicate devices. Testing demonstrated substantial equivalence without raising new safety or effectiveness questions.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/17/2024
7 months - 2
FDA Approval
4/16/2025
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