Altus Spine Navigation System
Altus Partners LLC.The Altus Spine Navigation System is a set of reusable surgical instruments designed to assist surgeons in accurately placing pedicle screws during spinal surgery. It works together with a navigation system that uses medical images like CT or MRI scans to help locate anatomical landmarks, improving precision in both open and minimally invasive procedures. This system helps enhance surgical accuracy and patient safety by guiding screw placement in the spine.
Intended Use
The Altus Spine Navigation System reusable instruments assist surgeons in precisely locating anatomical structures during preparation and placement of pedicle screws in spinal surgery, compatible with the Medtronic StealthStation System S8, for open or minimally invasive procedures using CT, MR, and fluoroscopy images.
Technology
The system consists of reusable surgical instruments designed for use with the Medtronic StealthStation Navigation System, which employs stereotactic navigation by referencing CT, MR, and fluoroscopy images to help locate spinal anatomical landmarks. Instruments include screwdrivers and taps compatible with Altus Spine pedicle screw systems, made from stainless steel, and are designed specifically to integrate with trackers and navigation software to aid accurate screw placement.
Performance
Performance testing included side-by-side comparison with a primary predicate device for recognition and location accuracy using the Medtronic StealthStation System S8, demonstrating equivalent dimensional accuracy and critical length measurements, confirming substantial equivalence in use and performance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/4/2024
6 months - 2
FDA Approval
5/8/2025
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