(55 days)
Davantis/Antelys Vertebral Body Replacements are vertebral body replacements for use in the lumbar and thoracic spine (T4-L5) to replace a damaged, collapsed or unstable vertebral body due to tumor or trauma (i.e. fracture). These are not stand-alone devices, ISOBAR 06.2 Hemispherical Screws with Offset Clamps and Ø5.5 Rods must be utilized to enhance the stability of the reconstruction in skeletally mature patients following full or partial corpectomy.
The DAVANTIS/ANTELYS Vertebral Body Replacements are oval shaped. The interior of the spacers has three compartments to provide space for bone graft. The implanted in the vertical position. These components are available in various heights (9mm-75mm). The superior and inferior surfaces of these components have ridges to interface with the vertebral endplates to resist rotation. The body has a multitude of holes to allow additional impaction of bone graft.
The DAVANTIS!ANTELYS components are fabricated from pure poly(ether ether ketone) (PEEK). This material closely matches the modulus of elasticity of cortical bone, improving the biomechanical interface and reducing the stress shielding effect. They are fully radio-translucent, which enables optimum follow-up with diagnostic imaging, as the interbody fusion progresses. Two metal wires at the opposite ends of the spacers allow radiological confirmation of the cage position post operatively.
This document is a 510(k) summary for the DAVANTIS/ANTELYS Vertebral Body Replacement device, which describes its intended use, design, and equivalence to a previously cleared device. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The 510(k) process is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It typically relies on comparison to a predicate device and often involves bench testing, rather than clinical studies with quantifiable performance metrics against acceptance criteria.
Therefore, I cannot provide the requested information from the provided text, as it describes a regulatory submission (510(k)) that focuses on substantial equivalence, not on studies proving specific acceptance criteria.
§ 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.