(90 days)
The VBR™ is a vertebral body replacement device intended for use in the thoracic and lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture).
The VBR 11 is intended to be used with supplemental internal spinal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Such systems include posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems.
The use of bone grafting material with the VBR™ is optional.
The VBR™ is a cylindrically shaped implantable titanium alloy device indicated for use in the thoracic and lumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The VBRTM is also indicated for treating fractures of the thoracic and lumbar spine.
The VBR™ consists of three (3) basic components, at least two (2) of which are threaded, such that the VBR™ is distractible and retractable by means of rotating the center ring or cylinder. A plurality of holes are built in the wall of the VBR™, transverse to the longitudinal axis. A row of holes in one or more of the cylinders is threaded to accept a set screw which, when tightened, serves to prevent further movement (distraction, retraction, or turning) of the VBR™ once the desired height has been achieved. The holes and the hollow core also allow for packing of bone grafting materials to help promote a solid fusion. A ring of small spikes or teeth on each end of the device serves to grip the endplates of the adjacent vertebrae for resisting expulsion.
The VBR™ is manufactured from titanium alloy (Ti6Al4V) which conforms to ASTM F136-92 and ISO 5832/3 standards.
The VBR™ is available in different sizes. Diameters of 20-28 mm with distraction lengths from 25 mm to 130 mm have previously been cleared (K003155). This current submission covers additional diameters ranging from 12 mm to 16 mm and distraction lengths from 10 mm to 65 mm, to better match patients' anatomical requirements.
The VBR™ is for single patient use and is offered for sale non-sterile. They must be sterilized prior to use.
The provided text describes a 510(k) submission for a medical device called VBR™ (Vertebral Body Replacement Device). It details the device's purpose, components, and how it compares to predicate devices. However, the document does not contain explicit acceptance criteria or a detailed study description with performance metrics, sample sizes, ground truth establishment, or expert qualifications as requested in the prompt.
The document only states that:
"Mechanical testing and a clinical study have been conducted on the VBR™ with the smaller diameters to show equivalence to predicate devices and demonstrate its capability to withstand in vivo loads."
This is a high-level statement indicating that studies were performed, but it does not provide any of the specific information needed to answer the detailed questions about acceptance criteria and study results. Therefore, I cannot construct the requested table or populate the other sections of your input.
§ 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.