(30 days)
When intended as an adjunct to fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft 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 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 components contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel.
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.
The presented document is a 510(k) summary for the VERTEX® Reconstruction System, a spinal fixation device. This type of document is a premarket notification for a medical device submitted to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
The 510(k) summary focuses on demonstrating "substantial equivalence" rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as would be seen for AI/ML-driven devices.
Therefore, many of the requested criteria for AI/ML device studies are not applicable to this document. The study described is primarily a mechanical testing comparison to predicate devices.
Here's an breakdown of the information that can be extracted and what is not applicable:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (K003780, K042789, K052376, K053483 for VERTEX® systems, and K014296 for CD HORIZON® Spinal System). | "Documentation was provided demonstrating that the VERTEX® Reconstruction System is substantially equivalent to other commercially available posterior fixation systems and other pre-enactment devices including the VERTEX® Reconstruction System in K003780 (S.E. 9/28/01), K042789 (S.E. 12/21/04), K052376 (S.E. 9/26/05), and K053483 (S.E. 1/15/06) and in CD HORIZON® Spinal System K014296 (S.E. 12/10/02)." |
| Mechanical testing results of subject device components comparing to predicate device components. | "The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to the testing performed for the predicate VERTEX® Reconstruction System components." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable: This document describes mechanical testing for substantial equivalence, not a clinical study or an AI/ML model's test set on human data. The "sample size" would refer to the number of components tested mechanically, which is not specified in this summary.
- Data provenance: Not specified, as it's mechanical test data, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable: Ground truth for AI/ML models or clinical diagnostic studies is not relevant here. The "ground truth" for mechanical testing would be established by engineering standards and validated testing protocols, not expert consensus on medical images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable: Adjudication methods are used in clinical studies or AI/ML model evaluations where there might be disagreement in expert interpretation. This is not how mechanical testing is assessed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable: This device is a surgical implant system, not an AI-assisted diagnostic tool or a system that involves "human readers." No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable: This device is a physical surgical implant. There is no algorithm or standalone performance in the context of AI/ML.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For mechanical testing: The "ground truth" is defined by established engineering and biomechanical standards for spinal implant performance, typically involving load-to-failure, fatigue testing, and other mechanical property assessments. It's not a clinical "ground truth" like pathology or outcomes.
- For substantial equivalence: The "ground truth" is the performance and characteristics of the predicate devices.
8. The sample size for the training set
- Not applicable: This involves mechanical testing for substantial equivalence, not an AI/ML model with a training set.
9. How the ground truth for the training set was established
- Not applicable: See above. There is no "training set" in the context of this 510(k) submission.
§ 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.