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The NuVasive Decade Lateral Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels, in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, spondylolysis, spondylolisthesis, and pseudarthrosis or a failed previous spine surgery.

The NuVasive Brigade Anterior Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels, in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, spondylolysis, spondylolisthesis, and pseudarthrosis or a failed previous spine surgery.

The NuVasive Traverse Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels, in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor. degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, spondylolisthesis, and pseudarthrosis or a failed previous spine surgery.

The NuVasive Thoracolumbar Plates is a lateral or anterolateral thoracolumbar plating system that consists of a variety of implant components including plates, bolts and screws, as well as associated manual general surgical instruments. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The subject device components are manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3. In addition, the Brigade Anterior Plate System also includes a Nitinol Spring Lock (NSL) manufactured from Nickel-Titanium alloy (Nitinol SE508) per ASTM F2063, and the Traverse Plate System (2+2 Compression Plate and 4-Screw Hole Fixed Plate only) includes a canted coil locking mechanism manufactured from Nickel-Cobalt-Chromium-Molybdenum alloy (MP35N) conforming to ASTM F562.

The NuVasive Thoracolumbar Plates (comprising NuVasive Decade Lateral Plate System, NuVasive Brigade Anterior Plate System, and NuVasive Traverse Plate System) did not undergo new performance testing for this 510(k) submission (K200956). The submission aimed to expand indications for use to include spondylolysis and spondylolisthesis, and clarify that failed previous spine surgery includes pseudarthrosis. Minor design modifications were made to certain devices within the Decade Lateral Plate System and Traverse Plate System, but these were confirmed not to create a new worst-case scenario requiring additional testing.

The substantial equivalence determination was based on the fact that the new indications for spondylolysis and spondylolisthesis use do not change the biomechanical stresses on the individual implants. Therefore, the device relies on the performance data and acceptance criteria established during the clearance of its predicate devices, where the worst-case devices included with the subject system were tested.

Since no new specific acceptance criteria or performance studies were conducted for this particular 510(k) submission, the information requested below cannot be extracted directly from the provided text for this specific submission. The document states that "no performance testing was performed for this 510(k) submission and the worst case devices included with the subject system were tested and cleared in predicate 510(k) submissions."

However, based on the general context of medical device clearance, the device likely meets acceptance criteria related to biomechanical performance (e.g., strength, fatigue, static and dynamic loading) that were established during the original predicate device clearances (K130868, K121837, K103750). These criteria would typically evaluate the device's ability to maintain spinal stability under various physiological loads.

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