(29 days)
The Quantum Vertebral Body Replacement is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.
The Quantum Vertebral Body Replacement is a generally box-shaped device with various holes located throughout its geometry. The exterior surface of the device has teeth to help keep the device from migrating once placed in its desired location. It is available in a multitude of sizes to suit the individual pathology and anatomic condition of the patient. The device may be made from titanium or polyetheretherketone (PEEK).
The provided text describes the Quantum Vertebral Body Replacement device and its intended use, but it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or any of the detailed performance study parameters requested.
The "Performance Data" section merely states: "Mechanical testing indicates that the Quantum Vertebral Body Replacement is capable of performing in accordance with its intended use." This is a very general statement and does not provide any specifics about the testing or its results.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using only the provided text. The document is a 510(k) summary, which typically focuses on substantial equivalence to a predicate device rather than detailed performance study results that would include acceptance criteria and specific data.
§ 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.