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FDA issues 510(k) clearance for Intelligent Implant Systems cervical-thoracic spinal system

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Intelligent Implant Systems LLC has received 510(k) clearance from the FDA for the sale of its Marauder Cervical-Thoracic Spinal System in the United States.

According to a company press release, the Marauder Spinal System uses an advanced locking system that requires no torque or set screws. The design allows easier rod reduction as the screw head will temporarily remain where positioned to ease rod reduction. After rod reduction is complete, the implant is locked into its final position with a locking cap using a one-handed instrument.

The Cervical-Thoracic Spinal System polyaxial screws are available in 3.5-mm and 4.0-mm diameters. Hooks are also available, which attach to a 3.5-mm rod and use the same torque-less technology for locking.

“This addition to our product line expands our product portfolio, and along with planned implant additions, will provide a state-of-the-art system to treat the entire posterior spine. We additionally intend to incorporate this system with our exclusive Active Screw system to provide surgeons and patients a superior fixation option,” Marc Richelsoph, president and chief executive officer of Intelligent Implant Systems, stated in the release.