(98 days)
The x•POD Adjustable Vertebral Body Replacement is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (e.g., fracture).
The x•POD Adjustable Vertebral Body Replacement 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. It is recommended that bone graft material be packed in the interior openings of the device prior to implantation.
The x•POD Adjustable Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems, such as the BodyForm Thoracolumbar Fixation System (K983622, SE 12/98) or Coral Pedicle Screw System (K041592, SE 9/04).
The x•POD Adjustable Vertebral Body Replacement is comprised of a cylindrical titanium (Ti-6Al-4V) mechanism with rectangular endplates. The system has fenestrations axially and laterally to maximize bone graft placement. The implants are manufactured in a variety of geometric combinations to better fit each patient's pathology. The anatomically designed endplates are designed to minimize expulsion and rotation of the implant postoperatively. The x•POD Adjustable Vertebral Body Replacement is manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136 and ISO 5832-3 standards. The x•POD Adjustable Vertebral Body Replacement construct is used individually and is always implanted with the construct oriented vertically.
This is a 510(k) premarket notification for a spinal implant device (x•POD Adjustable Vertebral Body Replacement), not a diagnostic AI device. Therefore, the provided text does not contain information about acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details as these are not relevant to the approval process for this type of medical device.
The approval is based on "substantial equivalence" to legally marketed predicate devices, meaning it has similar intended use, design, and physical characteristics, and performs comparably in mechanical testing, not through clinical performance metrics like sensitivity or specificity.
Therefore, I cannot provide the requested information.
§ 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.