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The NuVasive X-CORE® Expandable VBR System is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) 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 NuVasive X CORE® Expandable VBR System is intended to be used with supplemental internal spinal fixation systems 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 NuVasive X-CORE® Mini Cervical Expandable VBR System is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following Corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The NuVasive X-CORE® Mini Cervical Expandable VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.

These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The NuVasive X-CORE® Mini Cervical Expandable VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

X-Core Expandable VBR and X-Core Mini Cervical Expandable VBR devices are vertebral body replacement devices manufactured from Titanium alloy Ti6Al-4V ELI conforming to ASTM F136 and ISO 5832-3. Devices are offered in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The purpose of this 510(k) application is to add the sterile implants option to the previously cleared system.

I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study that proves a device meets such criteria. The document is an FDA clearance letter for a medical device (NuVasive X-Core® Expandable VBR System), outlining its indications for use, technological characteristics, and stating its substantial equivalence to predicate devices. It mentions performance data related to sterilization and packaging but does not include details on acceptance criteria or clinical/comparative studies involving device performance metrics as requested in your prompt.

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