(66 days)
VLIFT®-s Vertebral Body Replacement System is indicated for use in the cervical spine (C3-C7) and the thoracolumbar spine (T1-L5) in skeletally mature patial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectorny performed to achieve decompression of the spinal cord and neural tissue in degenerative disorders.
The VLIFT®-s Vertebral Body Replacement System is intended for use with autograft oone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The VLIFT®-s Vertebral Body Replacement 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, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
The VLIFT®-s Vertebral Body Replacement System is intended to be used with FDA-cleared spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.
The VLIFT®-s Vertebral Body Replacement System is intended for use as an aid in spinal fusion and consists of a single, pre-assembled distractible implant. The device may be distracted continuously via an inner concentric ring. The hollow core of the cage allows for packing bone graft. As the implant is distracted via its inner concentric ring, additional slotted openings appear.
The VLIFT®-s cages are available in various diameters and heights.
Modular end caps snap into each end of the VLIFT®-s implant. Serrated teeth at the rim of the end cap attachments help to anchor the implant to the end plates of the vertebral bodies. The VLIFT®-s end caps are available in both flush and contoured designs and are offered in a variety of angles.
Extension pieces are available for each diameter for the VLIFT®-s implants. Extension pieces may be used to achieve the desired height. The use of extension pieces is optional.
The provided text is a 510(k) summary for a medical device called the "VLIFT®-s Vertebral Body Replacement System." This document is not for an AI/ML device, but rather a physical implant. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable or available in this document.
The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices for an expanded indication of use (cervical spine). It emphasizes that no changes were made to the actual implants and, consequently, no additional testing was required or performed due to the existing clinical literature demonstrating substantial equivalence.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.