Search Results

The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.

With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORUZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation' attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations with each construct being tailormade for the individual case.

A subset of CD HORIZON® Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, CROSSLINK® Plates and connecting components. Similarly to the CD HORIZON® implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

The purpose of this Traditional 510(k) is to modify Medtronic's CD HORIZON® Spinal System to add additional components to the system, specifically, Top-Loading SOLERA® lateral connectors. The subject lateral connectors are a titanium implant that consists of a post and a top loading head interconnection feature for lateral connection to the CD HORIZON® Spinal System.

This document describes the regulatory submission for the Medtronic CD HORIZON® Spinal System, specifically for the addition of Top-Loading SOLERA® lateral connectors. The information provided heavily relies on equivalency to predicate devices and presents mechanical testing as the primary method to demonstrate safety and effectiveness for the new components.

Here's a breakdown based on your request, focusing on the mechanical testing and biocompatibility:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample size for the mechanical tests. It only states that "Non-clinical mechanical testing was performed."

The data provenance is internal to Medtronic Sofamor Danek USA, Inc., and the testing was conducted during the device development and regulatory submission process. It is retrospective in the sense that it's performed on manufactured devices to demonstrate compliance for a specific submission, but it's not clinical data from patients. The country of origin of the data would be the US, where Medtronic Sofamor Danek USA, Inc. is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable in this context. The "ground truth" for mechanical testing is established by engineering standards (ASTM F1798) and the physical properties of the materials and device design, not by expert interpretation. Experts (engineers, scientists) would be involved in designing and conducting the tests, but their role is not to establish a "ground truth" in the same way a medical expert would for a diagnostic study.

4. Adjudication Method for the Test Set

This is not applicable. Mechanical tests have objectively measurable outcomes (e.g., force at failure, cycles to failure). There is no "adjudication" in the sense of resolving disagreements among observers; results are recorded and compared against predefined pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This is not applicable. This submission is for a medical implant (spinal system), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance would not be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. As mentioned above, this is for a medical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth for the mechanical testing is defined by engineering standards (specifically ASTM F1798) and the performance requirements derived from these standards. For biocompatibility, the "ground truth" is established by long-standing clinical use data and material specifications (ASTM F136).

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of mechanical testing or biocompatibility assessment for a medical implant in this manner.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reasons as #8.

Ask a specific question about this device