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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 (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 and/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 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 adolescent idiopathic scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by turnor and/or trauma. 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 (TI-SI) 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.

Device Description

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.

Certain components within the CD HORIZON® Spinal System are specifically excluded for use in pediatric patients. These include PEEK rods, Shape Memory Alloy Staples, SPIRE™ Plates and DYNALOK® bolts. All screws used in pediatric cases are only cleared for use via a posterior approach. All of the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, and medical grade cobalt-chromium-molybdenum alloy.

Certain implant components from other Medtronic spinal systems can be used with the CD HORIZON® Spinal System in non-pediatric cases. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples, washers, GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNALOK® PLUS and DYNALOK CLASSIC® bolts along with rod/bolt connectors; and Medtronic Multi-Axial rods and screws. Please note that certain components are specifically designed to connect to specific rod diameters, while other components can connect to multiple rod diameters. Care should be taken so that the correct components are used in the spinal construct.

CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and associated screws are intended for anterior use only. However, for patients of smaller stature and pediatric patients, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.

The CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, medical grade cobaltchromium-molybdenum alloy, or medical grade PEEK OPTIMA-LT1. Certain CD HORIZON® Spinal System components may be coated with hydroxyapatite. No warranties expressed or implied are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.

Never use stainless steel and titanium implant components in the same construct. Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromiummolybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct.

The CD HORIZON® Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt-chromium-molybdenum alloy. Do not use with stainless steel. These staples are not to be used in pediatric patients.

PEEK implants may be used with stainless steel, titanium, or cobalt-chromiummolybdenum alloy implants. CD HORIZON® PEEK Rods are not to be used with CROSSLINK® Plates or in pediatric patients.

The purpose of this 510(k) submission includes the addition of uni-axial screws into the CD HORIZON® Spinal System. The subject uni-axial screws are a four-piece subcomponent assembly like the predicate multi-axial screws consisting of a bone screw, ring, crown, and head; however, instead of the screw assembly rotating in a multi-axial rotation, the screw pivots in a uni-axial direction.

AI/ML Overview

Here's an analysis of the provided text regarding the CD HORIZON® Spinal System, focusing on acceptance criteria and supporting studies, formatted as requested:

Acceptance Criteria and Device Performance

Acceptance Criteria (Implied by Equivalence)	Reported Device Performance
Substantial equivalence to predicate device (CD HORIZON® SOLERA™ 5.5/6.0 Multi-axial Screws (K113174) and CD HORIZON® LEGACY 4.5 Multi-axial Screws (K042025)) in:	The subject CD HORIZON® SOLERA™ 5.5/6.0 Uni-axial Screws are a modification of the predicate device, differing only in the pivot direction (uni-axial vs. multi-axial).
* Indications for Use	Identical to predicate device.
* Intended Use	Identical to predicate device.
* Performance Specifications	"The previously submitted testing for the CD HORIZON® LEGACY 4.5 multi-axial screw still applies." This implies the new device meets the same performance specifications (e.g., mechanical strength, fatigue resistance) through equivalence, without requiring new tests.
* Technological Characteristics	Very similar, with the key difference described above. Composed of the same materials (commercially pure titanium, titanium alloy, and cobalt-chromium-molybdenum). Available in solid and cannulated versions.
Risk Analysis Completion	A risk analysis was completed.
Appropriate Design Control Processes	An "assessment of the device modifications was completed in accordance with Medtronic design control processes."

Study Information

Sample Size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. No clinical testing was performed for this 510(k) submission. The non-clinical testing refers to the previously submitted data for predicate devices.
- Data Provenance: Not applicable. The submission relies on non-clinical (mechanical/material) testing data from previously cleared predicate devices (K113174 and K042025). The origin of that original testing data is not specified in this summary, but would typically be from the manufacturer's internal testing facilities.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No human expert-based ground truth was established for this submission, as it relied on non-clinical equivalence to predicate devices.
Adjudication method for the test set: Not applicable. No test set requiring adjudication was used.
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 is a spinal implant device, not an AI or diagnostic imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a spinal implant device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this 510(k) submission. The "ground truth" for demonstrating safety and effectiveness was based on the performance of previously cleared, substantially equivalent predicate devices (mechanical performance, material properties).
The sample size for the training set: Not applicable. This is a spinal implant device, not a machine learning model requiring a training set.
How the ground truth for the training set was established: Not applicable.

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