Search Results

The ENDURAMESH is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or autograft. The device must be used with a cleared supplemental fixation system.

The ENDURAMESH is a vertebral body replacement system which provides structural support of the vertebral bodies following an anterior or far lateral corpectomy, aiding in spinal fusion. The device must be used with a cleared supplemental fixation system.

The EDURAMESH vertebral body replacement system consists of a single cylindrically shaped titanium mesh cage. The hollow core of the cage allows for packing bone graft and the circular holes throughout the device promote bone fusions diameters and heights are available to accommodate variability among patients.

The provided text is a 510(k) Summary for a medical device called ENDURAMESH, a spinal intervertebral body fixation orthosis. This document focuses on demonstrating substantial equivalence to a predicate device for FDA clearance. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document primarily covers:

• Device Description: What the ENDURAMESH is and its purpose.
• Indications for Use: The medical conditions and spinal locations for which the device is intended.
• Substantial Equivalence Information: A comparison of the ENDURAMESH with a predicate device (an earlier version of ENDURAMESH K093207) to show that it is similar in design, material, and intended use. The only notable difference highlighted is the addition of new height options (35mm, 37mm, 39mm) for the modified ENDURAMESH.
• FDA Clearance Letter: Official communication from the FDA confirming substantial equivalence based on the submitted information.

Therefore, I cannot provide the requested table or answer questions 2 through 9 because the provided text does not contain any details about acceptance criteria, specific performance studies (like clinical trials or standalone algorithm evaluations), sample sizes, data provenance, expert ground truth, adjudication methods, or MRMC studies. The clearance was based on substantial equivalence, material information, and analysis data (which are not detailed here), rather than a separate study proving against specific acceptance criteria.

Ask a specific question about this device