Aurora Spine Corporation, a company based in Carlsbad, CA that focuses on spinal implant technologies, has received FDA 510(k) clearance for the minimally invasive ZIP MIS Interspinous Fusion System. The ZIP system provides surgeons an alternative to the prevalent pedicle screw technologies to perform spinal fixation. The device is intended for treatment of degenerative disc disease, spondylolisthesis, spinal tumors,and trauma, and is used to provide stabilization during non-cervical spine (T1-S1 lumbar) fusion procedures. The device is designed to be attached to plate fixation for supplemental fusion.
The system does not require the use of a set screw and makes use of a one-step zip locking mechanism and articulating bone anchors to provide optimal seating of the implant in the spine. The articulating spikes which have 14 degrees of controlled articulation are designed for caudal and cephalic insertion with improved anatomic conformity. The ZIP system also provides a large graft space intended to be filled with biologic material such as the Zip-Graft to reinforce the spine. The ZIP system is not intended for stand alone use, and has to be implanted along with a bone graft.
Press release: Aurora Spine Receives FDA 510(k) Clearance for ZIP™ MIS Interspinous Fusion System…
Product page: ZIP MIS Interspinous Fusion System…
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