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The Titanium Mesh System is indicated 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), to achieve anterior decompression of the spinal cord and other neutral tissues, and to restore the height of a collapsed vertebral body. The Titanium Mesh is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period

The Titanium Mesh is a vertebral body replacement system comprised of several different cross-sectional shaped implants with various heights. The different cross-sectional shaped shapes include: round, oval, oblong and kidney (banana) shaped implants. The height of the implants varies from 7mm to 130mm. In addition, some of the implants are trapezoidal, i.e., the posterior side of the implant is lower than the anterior side of the implant. A cutting tool allows for trimming of the implants to the desired height at surgical site. The interior of the mesh is open and provides a space that can be filled with bone graft material. The sidewalls of the mesh are perforated by several holes and allow for bone fusion through the sidewalls of the mesh. There are several ribs running longitudinally along the internal walls of the mesh. Standard and trapezoidal end caps that correspond to the various cross-sectional shapes of meshes are included in the system. The end caps are placed on top of and supported by the longitudinal ribs located at the internal wall of the mesh. Also the end caps have prongs that provide a friction-locking feature between the caps and the ribs of the mesh. The end caps are manually pressed into the mesh. Serrations on the superior/inferior surface of the end caps provide stability and prevent movement of the implant.

The Titanium Mesh System is intended for use with supplemental internal fixation spinal systems.

This 510(k) premarket notification for the Titanium Mesh System (K032371) does not contain information on acceptance criteria for device performance or a study demonstrating the device meets such criteria.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

1. Indications for Use: The Titanium Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (fracture), to achieve anterior decompression of the spinal cord and other neural tissues, and to restore the height of a collapsed vertebral body. It is designed to restore biomechanical integrity of the spinal column even in the absence of fusion for a prolonged period.
2. Materials: Manufactured from surgical grade titanium alloy as described by ASTM F-1108 (Ti-6Al-4V).
3. Design: The device is a vertebral body replacement system comprising various cross-sectional shaped implants (round, oval, oblong, kidney/banana, some trapezoidal) with varying heights (7mm to 130mm). It includes a cutting tool for trimming, an open interior for bone graft material, perforated sidewalls for bone fusion, longitudinal ribs, and standard/trapezoidal end caps with prongs for friction-locking and serrations for stability.

The submission claims substantial equivalence to the SynMesh™ Spacer System (K003275), Surgical Dynamics™ Mesh Cage System (K003709), and DePuy AcroMed™ Surgical Titanium Mesh™ System (K003043).

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in the provided text, as this type of information is typically associated with clinical performance studies or specific performance testing data, which are not detailed in this 510(k) summary.

For medical devices like spinal implants, substantial equivalence generally relies on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or if it has different technological characteristics, that the new device does not raise different questions of safety and effectiveness and is as safe and effective as the predicate device. This often involves mechanical testing to demonstrate performance (e.g., strength, fatigue, subsidence) but the details of such tests and their acceptance criteria are not included in this summary.

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