Intelligent Implant Systems Gains Clearance for Cervical-Thoracic Spinal System

Charlotte, N.C.-based Intelligent Implant Systems LLC has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Marauder cervical-thoracic spinal system.

The system is made up of an advanced locking system that is designed to eschew the need for torque or set screws. The design is touted to allow 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. Intelligent Implant Systems is expanding the system and adding additional components that make use of the same patent pending technology for locking.

The cervical-thoracic spinal system polyaxial screws are available in diameters of 3.5 and 4.0 mm. In addition, hooks are available, which, like the polyaxial screws, attach to a 3.5 mm rod and use the same torque-less technology for locking.

“We are pleased to announce clearance to market the Marauder cervical-thoracic system in the United States,” said Marc Richelsoph, president and CEO of Intelligent Implant Systems. “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.”

Intelligent Implant Systems surgical solutions for orthopedics and both fusion and non-fusion applications of the spine.