The SYNAPSE™ System is an enhanced set of instruments and implants, including clamps, variable axis screws, hooks, transconnectors, transverse bars and rods, designed for posterior stabilization of the upper spine. These implants provide the flexibility required to accommodate variations in patient anatomy.
The SYNAPSE System uses 3.5 mm and 4.0 mm titanium alloy rods. When combined with the Occipital Cervical Fusion System and the Universal Spinal System, constructs can extend from the occiput to the lower spine.
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. pseudarthrosis); 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.
Contraindications for the use of the Synthes SYNAPSE OCT System include:
Mental or physical impairment, which compromises or prevents a patient's ability to comply with necessary limitations or precautions, may place that patient at a particular risk during postoperative rehabilitation.
Factors such as the patient's weight, activity level, and adherence to weight bearing or load bearing instructions have an effect on the stresses to which the implant is subjected. Additional factors which may preclude the possibility of fusion include any underlying physiological conditions such as kidney dialysis, cancer, osteopenia, smoking, or diabetes.
The SYNAPSE OCT System (hooks) is contraindicated for use in postlaminectomy cases.
|100° total cone of angulation on all 3.5 mm and 4.0 mm diameter cancellous screws||Allows flexibility for screw placement and rod capture|
|3.5 mm and 4.0 mm diameter titanium alloy rods||Improves stiffness and strength: 4.0 diameter rod is 49% percent stronger and 71% percent stiffer than 3.5 diameter rod*|
|Screw driver features a patent-pending threaded holding sleeve||Assists in disengaging the screw from the hex or T15
Eliminates screw “sticking” providing controlled screw insertion
*Yield strength is the point on the stress-strain curve beyond which the material begins deformation that cannot be reversed upon removal of the loading, as demonstrated in the cantilever bend model. Testing on file at DePuy Synthes Companies.
All medical devices have associated risks. Please refer to the package insert and other labeling for a complete list of indications, contraindications, precautions and warnings. For further information on DePuy Synthes Products, please contact your local DePuy Synthes Representative.