FDA Clears Spineology Interbody Fusion Device

FDA has cleared a Spineology 510(k) for the Rampart Duo Interbody Fusion System, which the company describes as the first device of its kind to combine PEEK (polyether ether ketone), titanium, and graft containment mesh elements. The device is designed to allow for “decreased retraction requirements when compared to current interbody systems,” it says. The minimized tissue retraction may reduce the potential for nerve damage and resulting leg pain associated with a lateral approach.

Spineology says that the PEEK spacer blocks are “positioned on the lateral aspects of the vertebral body, where the bone is naturally strongest, to provide solid anterior support. In addition, the central graft containment mesh allows for broad device deployment which increases graft footprint and facilitates conforming apposition of the graft to the endplate for fusion.”