Primus Spinal Fixation System
Spinal Elements Inc.The Primus Spinal Fixation System is a spinal fixation device designed to provide stabilization and immobilization for the thoracic, lumbar, and sacral spine regions. It includes screws, rods, and connectors that can be precisely placed with the aid of navigation instruments compatible with the Medtronic StealthStation System, which uses medical imaging data like CT and MRI scans to assist surgeons in accurate screw placement during spinal surgeries.
Intended Use
Intended to provide immobilization and stabilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (T1-S1).
Technology
Comprises screws, hooks, rods, and connectors for mechanical fixation. Navigation instruments assist in precise placement using the Medtronic StealthStation System which references CT, MR, and fluoroscopy images or digitized anatomical landmarks for stereotactic surgery.
Performance
The device underwent mechanical testing such as static and dynamic compression bending, static torsion, and tensile dissociation tests per ASTM standards, demonstrating performance equivalent to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/20/2024
2 months - 2
FDA Approval
2/21/2025
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