DePuy Synthes Spine has received 510(k) approval from the US Food and Drug Administration (FDA) for its Synapse Occipital-Cervical-Thoracic (OCT) System with posterior cervical screws.
The new cervical screws have been developed for use with a screw-rod posterior fixation system, while screw placement in this system was earlier limited to use for fixation in the thoracic spine (T1-T3) and occiput only.
DePuy Synthes Spine franchise unit leader Karen Rowley said: "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.
"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 offer immobilization and stabilization of spinal segments as an adjunct to fusion for the acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3).
It is also targeted for traumatic spinal fractures and traumatic dislocations, instability or deformity, failed previous fusions, tumors involving the cervical/thoracic spine and degenerative disease, including intractable radiculopathy and myelopathy, as well as neck and arm pain of discogenic origin and degenerative disease of the facets with instability.
In addition, it can restore the integrity of the spinal column in the absence of fusion for a limited time period in patients with advanced stage tumors, involving the cervical spine.
Using the 3.5mm/5.5mm and 4.0mm/5.5mm titanium tapered rods, the Synapse OCT System can also be linked to the titanium DePuy Expedium Spine System.