Spinal tech developer Spineology said today it won FDA 510(k) clearance for its Rampart Duo interbody fusion system.
The St. Paul, Minn.-based company said its newly-cleared Rampart Duo is the 1st device of its kind to combine PEEK, titanium and graft containment mesh elements.
“Rampart Duo is an innovative interbody fusion device that builds upon Spineology’s OptiMesh technology. The 510(k) clearance of Rampart Duo opens the door to the commercialization of a family of hybrid PEEK and graft containment mesh implants designed for interbody fusion. The implant is a great addition to our anatomy-conserving product offering,” CEO John Booth said in a press release.
The Rampart Duo is designed to include PEEK spacer blocks position at each end of the device with a flexible porous graft containment mesh to create a central graft cavity. The mesh is designed to be filled with bone craft material in order to deploy the device in the anterior-posterior direction, Spineology said.
“The implant design allows for decreased retraction requirements when compared to current interbody systems. The minimized tissue retraction may reduce the potential for nerve damage and resultant leg pain associated with the lateral approach,” Dr. Sandeep Kunwar said in prepared remarks.
“The device has been anatomically designed. 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,” Dr. Michael Wang said in a prepared statement.
“The small tubular retractor and streamlined instruments, including ones that allow for the placement of the device when a high iliac crest is present, may help preserve patient anatomy and limit operating room time,” Dr. Craig Kuhns said in prepared remarks.
Last month, Spineology said that it expanded its relationship with the Muscoloskeletal Transplant Foundation, making it the sole tissue provider for its allograft product lines.
The expanded deal makes MTF the sole provider of tissue for Minneapolis-based Spineology’s new Incite cortical fibers bone grafting solution.