(254 days)
The ARX Spinal System is intended for vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable vertebral body or portion thereof, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.
The ARX Spinal System 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 ARX Spinal System is always to be used with supplemental internal spinal fixation. Additionally, the ARX Spinal System may be used with bone graft.
The ARX Spinal System acts as a spacer to maintain proper vertebral body spacing and anqulation following a partial or total corpectorny. The device is surgically implanted between vertebral bodies from an anterior, anterior-lateral, or lateral surgical approach. The ARX Spinal System is manufactured from MC2, a ceramic material. The ARX Spinal System is for single level anterior spinal use from T1 to L5.
I am sorry, but the provided text does not contain information about the acceptance criteria for a device, nor does it describe any study that proves the device meets specific acceptance criteria.
The document is a 510(k) summary for the "Arx™ Spinal System", detailing its sponsor, trade name, classification, predicate devices, device description, and intended use. Pages 1 and 2 are a letter from the FDA confirming the substantial equivalence of the device to legally marketed predicate devices, allowing its marketing. Page 3 lists the Indications for Use.
Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving the device meets them based on the provided text.
§ 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.