Zenith Plate System Anterior Spinal Instrumentation

FDA-Cleared Indications

• Anterior stabilization of the spine using implanted plates and screws.
• Use as an adjunct to spinal fusion surgery when internal fixation is needed to support spinal alignment and healing.

Clinical Applications

• Anterior cervical or other anterior spinal fusion requiring plate-and-screw fixation, as specified by the device labeling.
• Stabilization of the spine after surgical preparation for fusion.
• Internal fixation of spinal segments with instability when anterior instrumentation is indicated.

Reported off-label uses

• Use in selected spinal deformity procedures beyond the specific anatomic levels or patient populations described in the device labeling.
• Use as part of complex revision or salvage spine surgery when the system is not specifically labeled for that indication.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The system is available in different plate and screw sizes; the surgeon must select components that match the patient's anatomy and the intended spinal level.
• Placement requires an anterior surgical approach and imaging or direct visualization to confirm the operative level, alignment, and implant position.
• The device is used with standard spinal fusion techniques and is intended for implantation by surgeons trained in anterior spinal instrumentation.
• MRI safety and conditional scanning requirements should be confirmed in the current manufacturer labeling and implant documentation before an MRI examination.
• Contraindications and precautions include active infection, inadequate bone quality or anatomy for fixation, allergy to implant materials, and inability to follow postoperative restrictions; the current instructions for use control.