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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