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The VERTE-STACK™ Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-STACK™ Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK™ device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, the Titanium DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, the Titanium TSRH® Spinal System, the Titanium CD HORIZON® Spinal System, the Titanium GDLH® Spinal System or their successors. Additionally, the VERTE-STACK™ device is intended to be used with bone graft.

The VERTE-STACK™ device, is a stackable PEEK spacer, which inserts between vertebral bodies in the anterior thoracic and lumbar spine. The device is intended for vertebral body replacement to aid in the surgical correction and stabilization of the spine. The construct is not intended to be employed as a stand-alone device. The VERTE-STACK™ device is fabricated and manufactured from POLYETHERETHERKETONE (PEEK OPTIMA LT) as described by ASTM F-1579. The tantalum marker used for this product is made to the voluntary standard of ASTM F-560.

The design of the VERTE-STACK™ device includes a variety of stackable components of different sizes and heights. The stackable components are designed to suit the individual patient pathology.

The VERTE-STACK™ device may be used individually, or stacked together in order to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

The VERTE-STACK™ Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability.

The purpose of this submission is to include additional components to the VERTE-STACK™ Spinal System.

The provided 510(k) summary for the VERTE-STACK™ Spinal System (K030736) is a premarket notification for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not typically found in a 510(k) summary like this.

Here's why and what can be inferred:

• Acceptance Criteria & Device Performance: The document does not specify quantitative acceptance criteria (e.g., specific thresholds for strength, durability, or clinical outcomes) or report device performance against such criteria. Instead, it states the device is "substantially equivalent" to previously cleared VERTE-STACK™ Spinal Systems (K023570 and K021791).
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth): Since the primary claim is substantial equivalence, a detailed clinical study with the elements listed is generally not required for a 510(k). This particular submission states its purpose is "to include additional components to the VERTE-STACK™ Spinal System," implying modifications or additions to an already cleared design. Demonstrating substantial equivalence typically relies on comparing design, materials, indications for use, and technological characteristics to an already legally marketed device, often through bench testing and sometimes non-clinical testing, rather than extensive human clinical trials.

Conclusion based on the provided document:

No information regarding acceptance criteria, detailed study design, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance studies, or how ground truth was established for such studies is present in this 510(k) summary. The device's "performance" is implicitly deemed acceptable because it is substantially equivalent to predicate devices that have already met regulatory requirements.

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