(151 days)
When intended to promote fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-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.
Occipitocervical Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks
The occipitocervical plate rods, plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine.
Occipitocervical constructs require bilateral fixation to C2 and below. Note: Segmental fixation is recommended for these constructs.
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.
Multi-axial Screws/Connectors
The use of multi-axial screws is limited to placement in T1-T3. 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.
In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.
The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plates, 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 tailor-made for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion. See the package inserts of both of those systems for labeling limitations,
The VERTEX® Reconstruction System is fabricated from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium. Medical grade titanium, medical grade titanium alloy, and/or medical grade cobalt chromium may be used together. Never use titanium alloy, and or/cobalt chromium with stainless steel in the same construct. The VERTEX® Reconstruction System includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt chromium implants only. Some multi-axial screws contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel. No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MDT Catalog or price list for further information about warranties and limitations of liability.
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 labeled to do so in this or another MEDTRONIC document. As with all orthopedic and neurosurgical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances.
This document is a 510(k) premarket notification for the VERTEX® Reconstruction System, a spinal fixation device. It is not a study that proves a device meets acceptance criteria, but rather a submission to demonstrate substantial equivalence to previously marketed devices. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics for a typical AI/software device cannot be extracted directly from this document.
However, I can provide what can be inferred from the document regarding the "study" that proves substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical equivalence to predicate devices (strength, durability, etc.) | "The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to or better than the testing performed for the predicate VERTEX® Reconstruction System components." |
| Material compatibility/safety | Device is fabricated from medical grade titanium, titanium alloy, and cobalt chromium. Compatible with Nitinol (shape memory alloy) and silicone adhesive. Explicitly states "Never use titanium alloy, and or/cobalt chromium with stainless steel in the same construct." |
| Indications for Use (consistent with predicate) | Indications for use are provided, which align with spinal fixation systems. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The "test set" in this context refers to the components of the VERTEX® Reconstruction System that underwent mechanical testing.
- Data Provenance: Not specified. This would typically be internal testing data (bench testing).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. The "ground truth" for a mechanical device is established through engineering specifications and objective mechanical testing. Human experts are not used to establish this type of ground truth.
4. Adjudication Method for the Test Set
- Not applicable. Mechanical testing results are typically objectively measured and compared to predefined criteria, not subject to adjudication in the human consensus sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human interpretation is involved. This document describes a surgical implant device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Mechanical Test Results: The "ground truth" for demonstrating substantial equivalence relied on objective measurements from mechanical testing (e.g., strength, fatigue, static/dynamic loading) and comparison to the performance of predicate devices.
- Material Science Principles: Ground truth for material compatibility and safety is based on established medical device material science and biocompatibility standards.
8. The Sample Size for the Training Set
- Not applicable. This is a physical device, not an algorithm that requires a "training set" for machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" or algorithm involved.
Summary of the "Study" Proving Substantial Equivalence:
The "study" referenced in this 510(k) submission is primarily a mechanical testing study (bench testing) that compared the performance characteristics of the new VERTEX® Reconstruction System components to those of previously cleared predicate devices (K052402, K052734). The acceptance criterion was that the new device's mechanical performance should be "equivalent to or better than" the predicate devices. The document explicitly states that this criterion was met. This type of submission demonstrates that the new device is as safe and effective as existing legally marketed devices, rather than presenting a novel clinical trial.
§ 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.