(21 days)
When intended to promote fusion of the cervical spine and the thoracic spine, (CI-T3), the VERTEXTM Reconstruction System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and Rods: The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Screws/Connectors: The use of screws (3.5mm, 4.0mm and 4.5mm cancellous and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. The screws are not intended to be placed in the cervical spine.
Titanium ATLAS™ Cable System to be used with the VERTEX™ Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.
The VERTEX™ Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with cach construct being tailormade for the individual case. Titanium ATLAS™ cable may be used with this system at the surgeon's discretion.
The VERTEX™ Reconstruction System is fabricated from medical grade titanium alloy. The VERTEX™ Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol – NiTi). Shape Memory Alloy is compatible with medical grade titanium alloy implants only. Do not use with stainless steel.
The purpose of this submission was to add modified CROSSLINK® Plates and set screws to the system.
The provided text describes a 510(k) premarket notification for the VERTEX™ Reconstruction System, a spinal interlaminal fixation orthosis. It indicates FDA clearance based on substantial equivalence to previously cleared devices. However, the document does not contain any information about acceptance criteria, detailed device performance studies, sample sizes, expert ground truth establishment, or any comparative effectiveness studies.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them. This type of detailed performance data is typically found in the full 510(k) submission, which is not fully available in this extract. The provided text is primarily the 510(k) summary and the FDA's clearance letter, which focus on indications for use and substantial equivalence to predicates rather than detailed performance metrics.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.