DePuy Synthes Spine receives 510(k) clearance to market SYNAPSE OCT System with posterior cervical screws

First Screw-Rod Occipital-Cervical-Thoracic System Cleared for the Use of Screws in the Posterior Cervical Spine

DePuy Synthes Spine today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its SYNAPSE^TM Occipital-Cervical-Thoracic (OCT) System with posterior cervical screws, the first time cervical screws have been indicated for use with a screw-rod posterior fixation system. Previously, screw placement in this system was limited to use for fixation in the thoracic spine (T1-T3) and occiput only. DePuy Synthes Spine is a part of the DePuy Synthes Companies of Johnson & Johnson.

“This is very exciting news as it will allow us in the surgeon community to further drive education and research on these important techniques. Additionally it enables us to work with companies like DePuy Synthes to create new, innovative solutions to help improve patient care in the posterior cervical space,” said Todd J. Albert, MD, Surgeon in Chief and Medical Director Korein-Wilson Professor of Orthopaedic Surgery, Hospital for Special Surgery, Weill Cornell Medical College.

“I am grateful to see DePuy Synthes taking the lead on this given their long history with cervical products and I am pleased the SYNAPSE System is the first system to receive these new indications,” Dr. Albert added.

According to the American Academy of Orthopaedic Surgeons (AAOS), the use of internal cervical fixation dates back more than 75 years and has evolved to include placing screws into the lateral masses of the cervical spine. However, until now, this technique has not been among the indications in product labeling.

“This expanded indication is significant in that DePuy Synthes Spine is now able to sponsor education on the technique and contribute to a greater understanding of its use in treating conditions of the cervical spine,” said Karen Rowley, Franchise Unit Leader, Spine. “As a company, we continue to pioneer new techniques, expand our portfolio of comprehensive solutions and provide industry leadership in education, research and innovation.”

The SYNAPSE OCT System, including SYNAPSE, OC Fusion and AXON™, is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The SYNAPSE OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the AXON and SYNAPSE Systems may be connected to the Synthes Universal Spinal System using parallel connectors and tapered rods. The SYNAPSE OCT System can also be linked to the titanium DePuy EXPEDIUM^® Spine System using the 3.5mm/5.5mm and 4.0mm/5.5mm titanium tapered rods.