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Depuy Synthes Spine gets FDA clearance for Synapse system

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DePuy Synthes Spine recently announced it has received 510(k) clearance from the FDA to market its Synapse Occipital-Cervical-Thoracic System with posterior cervical screws.

Previously, screw placement in this system was limited to use for fixation in the thoracic spine (T1-T3) and occiput only. The expanded clearance marks the first time cervical screws have been indicated for use with a screw-rod posterior fixation system, according to a company press release.

The Synapse Occipital-Cervical-Thoracic (OCT) System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 to T3).

Additionally, the system is intended to restore spinal column integrity, even in the absence of fusion for a limited time period in patients with advanced-stage tumors that involve the cervical spine, according to the release.

Reference: www.depuysynthes.com.