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, 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 tumor 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-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 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. See the MDT Catalog for further information about warranties and limitations of liability.

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 OPTIMA-LT1 implants may be used with stainless steel, titanium, or cobaltchromium-molybdenum alloy implants. CD HORIZON® PEEK Rods are not to be used with CROSSLINK® Plates or in pediatric patients.

To achieve best results, do not use any of the CD HORIZON® Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all orthopaedic and neurosurgical implants, none of the CD HORIZON® Spinal System components should ever be reused under any circumstances.

The purpose of this 510(k) was to add additional components to the system, namely SOLERA™ LONGITUDE® 4.75mm. 5.5mm and 6.0mm diameter rods, 6.0mm diameter commercially pure titanium rods and longer CHROMALOY™ Plus 5.5mm and 6.0mm diameter rods. The rods are manufactured out of commercially pure titanium and cobaltchromium-molybdenum alloy.

The document provided is a 510(k) summary for the CD HORIZON® Spinal System, focusing on the addition of new rod components. The "system" being evaluated is a medical device, specifically spinal implants. Therefore, the "acceptance criteria" and "device performance" relate to the mechanical properties of these implants and their ability to function safely and effectively within the human body.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Implied" Criteria: The document states that "The results were compared to the previously listed predicate devices." and that the subject devices "demonstrated substantial equivalence to the previously listed predicate devices." This strongly implies that the acceptance criteria for the subject devices (new rods) were to perform at least as well as, or equivalently to, the predicate devices in these mechanical tests.

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

• Sample Size: The document does not explicitly state the numerical sample size (e.g., number of rods tested) for the non-clinical mechanical testing. It refers generally to "worst case subject devices."
• Data Provenance: The data is from "non-clinical testing" (mechanical testing) performed by the manufacturer, Medtronic Sofamor Danek USA, Inc. The country of origin and whether it was retrospective or prospective are not specified, but mechanical testing of medical devices is typically performed in a controlled laboratory setting and is prospective in nature for a 510(k) submission.

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

• This is not applicable as the "ground truth" for this type of medical device (spinal implants) is established through standardized mechanical testing against performance benchmarks, not expert consensus on interpretations like with diagnostic images. The "ground truth" here is objective physical performance, measured in a lab.

4. Adjudication Method for the Test Set

• This is not applicable for mechanical testing. Adjudication methods like 2+1 or 3+1 are used for human-reviewed data (e.g., image interpretation), not for objective mechanical test results.

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

• This is not applicable. The device in question is a physical spinal implant system, not an AI-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

• The ground truth for evaluating these spinal implants is based on objective mechanical performance metrics defined by the ASTM F1798 standard and comparison to the established performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

• Not applicable. As this is a physical medical device and not a machine learning model, there is no "training set."

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

• Not applicable. There is no training set for this type of device.

Ask a specific question about this device