St. Paul-based Spineology has announced expanded FDA clearance of its Elite Expandable Interbody Fusion System.
Here's what you need to know:
1. The expanded clearance adds a narrower, 10mm, version of the device and grants its use with allograft bone.
2. The device can be inserted into the disc space at a contracted minimum height, expanding to restore anatomic disc height, provide anterior column support and potentially facilitate indirect decompression.
3. Elite allows the operating surgeon to control device expansion and lock the device at any position in the expansion range.
4. The device is made of titanium alloy and its large graft window enables bone through-growth which allows for maximum fusion potential.
5. Spineology CEO John Booth said, "The broader size offering and the allograft bone indication allow the surgeon to pair Elite with Incite Cortical Fibers… Incite's excellent handling properties and ability to expand in-situ with the Elite Implant are added benefits not found in competitive systems."
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