The US Food and Drug Administration (FDA) has approved Spineology's Rampart Duo interbody fusion system.
Rampart Duo is claimed to be the first device of its kind to combine PEEK, titanium, and graft containment mesh elements.
The system features PEEK spacer blocks, which are positioned at each end of the device. It also includes a flexible porous graft containment mesh that creates a central graft cavity.
Once implanted, the porous graft containment will be filled with bone graft to deploy the device in the anterior-posterior direction, and in the superior-inferior direction to offer conforming apposition with the vertebral endplates.
Spineology CEO John Booth said: “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.”
Earlier this month, Spineology also obtained FDA approval to use allograft bone with its Rampart Interbody Fusion Devices.
Rampart interbody fusion devices integrate large graft windows to facilitate healing and a recently improved instrumentation system.
The devices are available with sterile packaging, helping to avoid continual reprocessing.
Spineology provides anatomy conserving spinal technologies for surgeons and their patients.
The company produces interbody, fixation, and access systems to conserve spinal bone, ligament and muscle tissue.