(227 days)
The Stackable Cage" System is indicated for use in the thoracolumbar spine (i.e., T1 to LS) 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 Stackable Cage 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 Stackable Cage system is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Stackable Cage System include DePuy AcroMed titanium plate or rod systems (e.g., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, and Profile).
The Stackable Cage System consists of two componentsone or more stackable vertebral body replacement components (stackable cage implants) and a supplemental internal fixation system. The stackable cage implant is made of a polymer/carbon fiber composite material. One or more stackable cage implants may be stacked to the desired height, as determined by the surgeon. A titanium alloy screw can be passed through a center hole in the cages and with a nut provide a rigid and compressed assembly.
The structure of the stackable cage implants has been shown to support anticipated loads with a modulus of elasticity approximating that of cortical bone. The implants have ridges or teeth in both the anterior-posterior and mediallateral directions, which resist rotation and migration. The stackable cage implants have cavities to accept packing of bone graft. The entire structure is radiolucent so that healing can be assessed by normal radiographic methods. Additionally, radiotherapy can be performed immediately after surgery.
The provided text is a 510(k) summary for the Stackable Cage™ System, outlining its description, materials, indications, and substantial equivalence to a predicate device. It specifically mentions "Performance Data" which includes "Biomechanical testing, including static axial compression, torsional loading and cantilever beam testing, were conducted" and "Clinical data were provided to demonstrate the performance of the device in patients with spine tumors."
However, the document does not provide specific acceptance criteria or detailed results of these tests. It only states that these tests were conducted and that clinical data were provided to demonstrate performance. The document's primary purpose is to establish substantial equivalence for regulatory purposes.
Therefore,Based on the provided text, I cannot complete the requested tables and information. The document does not contain details about specific acceptance criteria, study methodologies (like sample sizes, ground truth establishment, expert qualifications, or adjudication methods), or outcomes (like reported device performance values) in the format requested.
The document states:
- Performance Data: "Biomechanical testing, including static axial compression, torsional loading and cantilever beam testing, were conducted. Clinical data were provided to demonstrate the performance of the device in patients with spine tumors."
This indicates that studies were performed, but no specifics are given regarding acceptance criteria or results.
§ 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.