(23 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 - NiTì). 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 previously cleared multi axial screws.
This is a 510(k) summary for a spinal implant system (VERTEX™ Reconstruction System), not an AI/ML medical device. Therefore, the provided documents do not contain the type of information requested, such as acceptance criteria, details of a study proving device performance, sample sizes for test/training sets, expert qualifications, or details on AI/ML specific evaluations like MRMC comparative effectiveness studies or standalone performance.
The 510(k) summary states that the purpose of the submission was to modify previously cleared multi-axial screws. The substantial equivalence section confirms that "Documentation has been provided which demonstrates that the modified VERTEX™ Reconstruction System multi axial screws are substantially equivalent to VERTEX™ Reconstruction System multi axial screws previously cleared in K003780."
In cases of device modifications seeking 510(k) clearance, the "acceptance criteria" are generally related to demonstrating substantial equivalence to a predicate device. This typically involves showing that the modified device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate. The "study" proving this usually involves:
- Bench testing: To evaluate mechanical properties (e.g., strength, fatigue, torsional stiffness) of the modified components and compare them to the predicate device and relevant standards.
- Materials testing: To ensure the modified materials meet specifications and are biocompatible.
- Design comparison: Detailed comparison of the design features of the modified device with the predicate.
Without the specific test reports and data from the original 510(k) submission (K042498) or its predicate (K003780), it's impossible to provide the detailed information requested in the table format. The provided text only states that substantial equivalence was demonstrated through "documentation."
§ 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.