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When intended as an adjunct to fusion in skeletally mature patients using allograft and/or autograft of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX Reconstruction System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed prev10us fusion and/or tumors

Occipitocervical Components Plate Rod/Plates/Rods/Occipital Screws/Hooks

The occipitocervical plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only The screws are not intended to be placed in the cervical spine

Occipitocervical constructs require bilateral fixation to C2 and below Note Segmental fixation is recommended for these constructs

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine

Multi-axial Screws/Connectors

The use of multi-axial screws is limited to placement in T1-T3 The screws are not intended to be placed in the cervical spine

Titanium ATLAS® Cable System to be used with the VERTEX Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine

In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors Refer to the CD HORIZON® Spinal System package insert for a hist of the CD HORIZON® Spinal System indications of use

The VERTEX Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion. See the package inserts of both of those systems for labeling limitations.

The VERTEX Reconstruction System is fabricated from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium. Medical grade titanium, medical grade titanium alloy, and/or medical grade cobalt chromium may be used together. Never use titanium alloy, and or/cobalt chromium with stainless steel in the same construct. The VERTEX Reconstruction System includes a retaining ring for the multi-axial screw made of Shape Memory Allov (Nitinol ~ NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt chromium implants only. The posted screw connectors and some multi-axial screws contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel.

To achieve best results, do not use any of the VERTEX Reconstruction System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another MEDTRONIC document. As with all orthopedic and neurosurgical implants, none of the VERTEX Reconstruction System components should ever be reused under any circumstances.

This document is a 510(k) summary for the VERTEX® Reconstruction System, a spinal implant device. It primarily discusses the device's description, indications for use, and substantial equivalence to existing predicate devices.

This document does not contain information on acceptance criteria, device performance, or any study involving human or even simulated data to prove the device meets specific performance criteria. It focuses on regulatory approval based on substantial equivalence to previously approved devices and mechanical testing results.

Therefore, I cannot provide a detailed response to your request, as the necessary information for acceptance criteria and a study proving their fulfillment is not present in the provided text.

Specifically, the document states:

• "VI. Substantial Equivalence Documentation was provided demonstrating that the VERTEX® Reconstruction System is substantially equivalent to other commercially available posterior fixation systems and other pre-enactment devices..."
• "The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to the testing performed for the predicate VERTEX® Reconstruction System components."

This indicates that the main "proof" for this submission was demonstrating substantial equivalence through comparison to legally marketed devices and equivalent mechanical testing, rather than a clinical performance study with specific acceptance criteria.

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