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When intended to promote fusion of the cervical spine and the thoracic spine, (CI-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 previous fusion and/or tumors.

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.

The use of screws (3.5mm, 4.0mm and 4.5mm cancellous and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. 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.

The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of 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 tailormade for the individual case. Titanium ATLAS™ cable may be used with this system at the surgeon's discretion.

The VERTEX® Reconstruction System is fabricated from medical grade titanium alloy. The VERTEX® Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol – NiTi). Shape Memory Alloy is compatible with titanium or titanium alloy implants only. Do not use with stainless steel.

The purpose of this submission was to add modified setscrews to the existing system.

The provided text is a 510(k) summary for the VERTEX® Reconstruction System, a spinal fixation device. It details the device's description, indications for use, and a claim of substantial equivalence to previously cleared devices.

Crucially, this document does not contain information about acceptance criteria or a study demonstrating the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or similar quantitative measures. The approval is based on "substantial equivalence" to existing cleared devices, primarily supported by mechanical test results.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide answers to the questions regarding sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. These types of details are not typically found in a 510(k) summary for a spinal implant device, as the regulatory pathway relies on demonstrating equivalence rather than establishing new performance benchmarks through clinical or AI-specific studies.

The document states:

• Substantial Equivalence: "Documentation, including mechanical test results, has been provided which demonstrates that the subject VERTEX™ Reconstruction System components are substantially equivalent to VERTEX® Reconstruction System components previously cleared in K042498 (SE 10/07/04) and K042789 (SE 12/21/04)."

This indicates that the "study" proving the device met the criteria was a demonstration of its mechanical and material properties being comparable to already approved devices, rather than a clinical trial or performance study against specific acceptance criteria for diagnostic or algorithmic performance.

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