(28 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 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
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.
Connectors
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. Transition rods with differing diameters may also be used to connect the VERTEX® Reconstruction System to the CD HORIZON® Spinal System screws, hooks, and connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.
The VERTEX SELECT® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multiaxial 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, 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 orthopaedic and neurosurqical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances.
The purpose of this Special 510(k) is to add additional components to the VERTEX® Reconstruction System: namely a fixed length and lower profile CROSSLINK® Connector to allow the surqeon additional construct rigidity options when using the VERTEX® Reconstruction System rods and connector components.
This document is a 510(k) premarket notification for the VERTEX® Reconstruction System, specifically for the addition of new components (fixed length and lower profile CROSSLINK® Connector). As such, it's a submission to demonstrate substantial equivalence to a legally marketed predicate device, not typically a study proving performance against acceptance criteria in the way a novel AI or diagnostic device would.
Therefore, many of the typical "acceptance criteria" and "study" elements you've requested (e.g., sample size, ground truth, MRMC study, standalone performance) are not applicable in this context. This submission focuses on non-clinical testing and an engineering rationale rather than clinical trial data demonstrating performance against specific clinical endpoints.
Here's a breakdown of the available information based on your request, highlighting what is and isn't present:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present a formal table of "acceptance criteria" for the new components in the way a diagnostic device might have performance metrics. Instead, "acceptance" for a 510(k) submission is based on demonstrating substantial equivalence, which is achieved through an engineering rationale and risk assessment for changes to existing devices.
The "performance" is implicitly deemed equivalent to the predicate devices because the new components do not introduce new issues of safety or effectiveness, share the same materials, indications for use, and intended use.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical test set in the traditional sense was used. The submission relies on an engineering rationale and risk assessment for the component modification.
- Data Provenance: Not applicable. No patient data (retrospective or prospective) was used for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. No ground truth establishment by experts for a test set was performed.
4. Adjudication Method for the Test Set
- Not applicable. There was no test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size
- Not applicable. This is not a study assessing human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (spinal implant components), not an algorithm or AI.
7. The Type of Ground Truth Used
- Not applicable. No ground truth in the context of diagnostic accuracy was established. The "ground truth" for this submission is that the modified device, through engineering and risk analysis, is considered substantially equivalent to already cleared devices.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable.
Summary of the Study/Rationale Presented in the Document:
Instead of a typical performance study with acceptance criteria, this 510(k) submission (K123568) for the VERTEX® Reconstruction System's new CROSSLINK® Connector relied on:
- Engineering Rationale: Demonstrating that the modifications (fixed length and lower profile CROSSLINK® Connector) maintain the same material, indications for use, intended use, and performance specifications as the predicate devices.
- Risk Assessment: Proving that the new CROSSLINK® does not introduce new issues of safety or effectiveness.
- Substantial Equivalence: The primary "acceptance criterion" for a 510(k) is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.
Predicate Devices:
The predicate devices identified are:
- VERTEX® Reconstruction System (K082728 - SE 01/16/2009)
- VERTEX® Reconstruction System (K023555 - SE 11/22/2002)
Conclusion:
The FDA reviewed the provided engineering rationale and risk assessment and determined that the VERTEX® Reconstruction System (with the added components) is substantially equivalent to its predicate devices, hence accepting the submission and allowing continued marketing.
§ 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.