Search Results

The EXPANSE Vertebral Body Replacement (VBR) Device is indicated for use in the thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body which has been resected or excised (i.e., partial or total vertebrectomy) due to tumor or trauma (i.e., fracture).

The EXPANSE VBR Device 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 EXPANSE VBR Device is intended to be used with bone graft and supplemental fixation. The supplemental internal fixation systems that may be used with the EXPANSE VBR Device include the Zodiac Polyaxial Pedicle Screw System, the Expedium Spinal System, the Expedium Anterior system, and the CD Horizon Spinal System, or equivalent systems.

The EXPANSE VBR Device may be implanted singularly or in pairs.

The EXPANSE device is manufactured from implantable grade titanium 6Al-4V alloy that conforms to ASTM F- 136. The device consists of opposing surfaces that make contact with the bony endplates of the vertebral bodies and can be expanded 2 mm in height. Following expansion, a shim is inserted between the opposing surfaces to provide mechanical integrity of the implanted device. Each surface in contact with the bony endplates is roughened to provide positive engagement with the endplates to resist rotation and migration.

The EXPANSE is offered in five heights and a single length to provide the surgeon anatomic flexibility.

The regulatory submission describes the EXPANSE Vertebral Body Replacement Device and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is a 510(k) summary, not a detailed clinical or performance study report. The 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting novel performance metrics against specific acceptance criteria.

Therefore, I cannot extract the requested information, as performance data, sample sizes, ground truth establishment, expert qualifications, and study designs are not typically part of the provided 510(k) summary. The document primarily focuses on device description, indications for use, and a declaration of substantial equivalence based on intended use, scientific technology, materials, and design, supported by biocompatibility assessment and bench testing without specifying detailed results or acceptance criteria.

Ask a specific question about this device