Device typeIntervertebral disc prolapse repair implant: An implantable device intended to treat a prolapsed lumbar intervertebral disc by repairing the defect in the annulus fibrosus for the prevention of recurrent herniation of the nucleus pulposus. It consists of a mesh plug used to replace the disrupted segment of the annulus, and an attached anchor used to stabilize the plug by fixation to the adjacent vertebral body. It is made of polymer and metallic materials and implanted during a posterior approach procedure. Disposable devices associated with deployment (e.g., pusher, sheath) may be included.
FDA categoryReherniation Reduction Device
Device IDM906AT8NARROW0
Catalog numberAT-8-NARROW
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional