Search Results

The NuVasive® CoRoent Thoracolumbar Implants are devices indicated for the following:

Intervertebral Body Fusion

The NuVasive CoRoent Thoracolumbar Implants are indicated for intervertebral body fusion of the spine in skeletally mature patients. The implants are designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation system cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

Thoracic Spine:

The CoRoent Thoracolumbar Implants are intended for use for thoracic interbody fusions at one or two contiguous levels in the thoracic spine, from T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).

Lumbar Spine:

The CoRoent Thoracolumbar Implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Partial Vertebral Body Replacement

The NuVasive CoRoent Thoracolumbar Implants may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (TI to LS) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The implants are intended to be used with supplemental internal spinal fixation systems (e.g., pedicle screw system) that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft material may be used at the surgeon's discretion.

The CoRoent Thoracolumbar Implants are manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026 or titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The PEEK device contains radiographic markers manufactured from titanium alloy conforming to ASTM F136 or ASTM F1472. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The hollow aperture allows for packing of autogenous bone graft. Teeth on the superior and inferior surface of the implants provide resistance to expulsion. The device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracolumbar spine. This Special 510(k) is for additional implant offerings for use in the thoracic spine.

The provided document is a 510(k) summary for the NuVasive® CoRoent® Thoracolumbar Implants. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study or performance data against a predefined benchmark.

Therefore, the document explicitly states:

• "No performance data was provided to demonstrate that the subject NuVasive CoRoent Thoracolumbar Implants are substantially equivalent to the predicate devices." (Page 5, "G. Performance Data")
• "Based on the technological characteristics and comparison to predicate devices, the subject NuVasive CoRoent Thoracolumbar Implants has been shown to be substantially equivalent to legally marketed predicate devices." (Page 6, "H. Conclusions")

Given this information, it is not possible to provide the details requested in "1. A table of acceptance criteria and the reported device performance" or any other points related to a study proving the device meets acceptance criteria, as such a study and performance data were not part of this 510(k) submission.

The document focuses on demonstrating substantial equivalence through:

• Device Description: Material composition (PEEK-Optima® LT-1 or titanium alloy), design features (hollow aperture for bone graft, teeth for expulsion resistance), and variations in shapes and sizes.
• Intended Use: Intervertebral body fusion for thoracic and lumbar spine, and partial vertebral body replacement in the thoracolumbar spine.
• Technological Characteristics: Comparison to predicate devices in areas including design, labeling/intended use, material composition, and function.

In summary, this document does not contain information about:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or ground truth establishment methods.
• Number of experts, their qualifications, or adjudication methods.
• MRMC comparative effectiveness studies or standalone algorithm performance.
• Ground truth types or training set sample sizes for AI/algorithmic performance, as this is a medical implant, not an AI device.

Ask a specific question about this device