(28 days)
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-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 and 4.0mm 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 described by such standards as ASTM F67 or ASTM F136 or ISO 5832-3 or 5832-2. The VERTEX™ Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol – NiTi) as described by ASTM F2063. Shape Memory Alloy is compatible with titanium or titanium alloy implants only. Do not use with stainless steel. Medtronic Sofamor Danek expressly warrants that these devices are fabricated from one of the foregoing material specifications. No other warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. Never use stainless steel and titanium implant components in the same construct.
To achieve best results, do not use any of the VERTEX™ Reconstruction System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic Sofamor Danek document. As with all orthopedic and neurosurgical implants, none of the VERTEX™ Reconstruction System components should ever be reused under any circumstances.
The purpose of this submission was to add 3.5mm and 4.0mm diameter bone screws along with a screw connector to the system.
This is a 510(k) summary for the VERTEX™ Reconstruction System, a spinal implant device. The provided text does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on:
- Device Description: What the VERTEX™ Reconstruction System is made of and its components.
- Indications for Use: The specific medical conditions and anatomical locations for which the device is intended.
- Substantial Equivalence: A statement asserting that the device is substantially equivalent to itself (implying a previous version or a minor modification of an existing device).
- FDA Correspondence: A letter from the FDA confirming the 510(k) clearance and reminding the manufacturer of regulatory responsibilities.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided document. This type of information (performance data, studies, and acceptance criteria) is typically found in the "Performance Data" or "Clinical Data" sections of a 510(k) submission, which are often more detailed than the public summary.
§ 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.