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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 (DDD - 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, kyphosis, 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 DDD, the CD HORIZON™ LEGACY™ 3.5mm rods and the CD HORIZON™ 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, or lordosis) 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, pseudarthosis, 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: DDD (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 VERTEXT™ 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 tailor-made 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 Special 510(k) is to add additional components to the Medtronic's CD HORIZON™ Spinal System. The devices being added are sterile domino connectors made using Titanium Alloy.

This document is a 510(k) premarket notification for the Medtronic Sofamor Danek CD HORIZON™ Spinal System, specifically for the addition of sterile domino connectors made of Titanium Alloy. It is not an AI/ML device, therefore, the requested information type cannot be extracted.

This document describes the safety and performance testing for a medical device (CD HORIZON™ Spinal System) and does not involve AI/ML. Therefore, I cannot extract information related to AI/ML device performance, such as:

• Acceptance criteria and reported device performance for an AI/ML device
• Sample size and data provenance for an AI/ML test set
• Number and qualifications of experts for AI/ML ground truth
• Adjudication method for AI/ML
• MRMC comparative effectiveness study for AI/ML improvement
• Standalone AI/ML performance
• Type of ground truth for AI/ML
• Sample size and ground truth establishment for AI/ML training set

The document primarily focuses on demonstrating substantial equivalence to predicate devices through biocompatibility and mechanical testing, which are standard for traditional medical implants. The key takeaway from the performance data section is that non-clinical mechanical testing was not performed on the sterile implants because they are "identical to the predicate devices in terms of material, rod compatibility sizes, rod interconnection features, intended use and indications for use." The predicate devices were tested according to ASTM F1798 and F1717, and this is deemed sufficient for the new components.

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