(28 days)
When intended to promote fusion of the cervical spine and the thoracic spine, (CI-T3), the VERTEX™ 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 each 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 or 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 titanium or titanium alloy implants only. Do not use with stainless steel.
The purpose of this submission was to modify the existing tulip head design into a smooth post screw, and to update the offset connector and eyebolt connection.
The provided text is a 510(k) summary for the VERTEX™ Reconstruction System. It is a submission to modify an existing medical device, specifically a posterior spinal system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. Key reasons for this are:
- 510(k) Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a predicate device (a device already legally marketed). This typically involves comparing device design, materials, indications for use, and technological characteristics, and showing that any differences do not raise new questions of safety or effectiveness. It generally does not require new clinical performance studies with acceptance criteria in the way a PMA (Pre-Market Approval) would.
- Device Type: The VERTEX™ Reconstruction System is a spinal implant system (rods, screws, hooks, connectors). The modifications described are to the tulip head design of a screw and updates to an offset connector and eyebolt connection. These are mechanical components. Performance is typically established through bench testing (e.g., fatigue, load-bearing) and material characterization, which are often cited by reference to established standards or previous submissions, rather than clinical studies with human subjects.
- Lack of Performance Data: The document explicitly states: "Documentation has been provided which demonstrates that the VERTEX™ Reconstruction System is substantially equivalent to VERTEX™ Reconstruction System that was previously cleared in K023555 and K003780." There are no sections detailing a study design, sample sizes, ground truth establishment, or performance metrics against specific acceptance criteria.
Conclusion:
Based on the provided text, I cannot complete the requested tables and information because the document describes a 510(k) submission focused on substantial equivalence rather than a study with defined acceptance criteria and performance data. There is no mention of a clinical study, human readers, AI assistance, or expert consensus protocols for evaluating performance.
§ 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.