The US Food and Drug Administration (FDA) has granted 510(k) clearance to the two-level thoraco-lumbar components of the Revolution spinal system from Intelligent Implant Systems.
Revolution is intended to simplify single and two-level thoraco-lumbar fusions by providing a sophisticated novel implant system which is implanted with a single tray of all-sterile instruments. The implants, which are provided sterile. The procedure is designed to be fast. According to a press release, surgeons need only to place the pedicle screws, attach the connectors, and lock with a single-use torque wrench. There are no rods to contour and, with the locking mechanism built-in, there are no set screws to place and potentially cross-thread.
The new components are intended to allow expansion to two-level fusions, while maintaining simplicity and the existing capabilities of the Revolution system. The same single-use instrument tray is used for a one or two-level procedure. The two-level system utilises the existing Revolution connectors, and requires only a minimum of additional components, according to the company release.