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 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 turnor.

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-LTI. 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™ 5.5mm and 6.0mm diameter rods and associated multi-axial screws, hydroxvapatite coated multi-axial screws, reduction multi-axial screws, fixed angle screws and setscrews. The components are manufactured out of medical grade titanium, titanium alloy and/or grade cobalt-chromium-molybdenum alloy with some components coated with hydroxyapatite. In addition, previously cleared TSRH® 5.5mm diameter rods were cleared for use with the CD HORIZON® Spinal System.

This document describes the CD HORIZON® Spinal System, which is a medical device used for spinal fixation. The provided information focuses on the non-clinical testing performed to demonstrate its substantial equivalence to previously marketed predicate devices.

Here's an analysis of the acceptance criteria and study as requested:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: The document refers to "worst case subject devices" and "worst case predicate devices" for mechanical testing (ASTM F1798, ASTM F1717, wear debris, and corrosion analysis). However, the specific number of samples (e.g., n=X for each test group) is not explicitly stated in the provided text.
• Data Provenance: The data is from non-clinical testing, specifically mechanical testing in a lab setting. The document does not provide details on the country of origin of the data or whether it's retrospective or prospective, as these terms are typically applied to clinical studies involving human subjects.

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

• Not applicable. This document describes non-clinical mechanical testing of an orthopedic implant. Ground truth, in the context of expert consensus, is typically established for diagnostic or clinical performance studies where human interpretation or clinical outcomes are assessed. For this type of mechanical testing, "ground truth" is defined by the established parameters and performance requirements of the ASTM standards and the predicate devices. The "experts" involved would be the engineers and technicians performing and analyzing the mechanical tests, ensuring adherence to the ASTM standards and accurate data collection. Their specific qualifications are not detailed.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies in expert interpretations (e.g., conflicting diagnoses). In this non-clinical mechanical testing, the "ground truth" is determined by objective physical measurements following standardized protocols (ASTM F1798 and F1717). The performance is compared directly to predefined acceptance criteria and predicate device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance:

• Not applicable. This document details the mechanical testing of a spinal implant. It is not an AI-assisted diagnostic or therapeutic device, and therefore, no MRMC study or assessment of human-AI collaboration effectiveness was performed or is relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable. This device is a physical spinal implant, not a software algorithm. Therefore, "standalone" performance in the context of
  an algorithm is irrelevant to this submission.

7. The Type of Ground Truth Used:

• The "ground truth" for this non-clinical study is defined by:
  • ASTM Standard Specifications: The performance requirements and methodologies outlined in ASTM F1798 and ASTM F1717.
  • Predicate Device Performance: The established mechanical performance characteristics of the legally marketed predicate devices. The subject devices' performance was compared to these.

8. The Sample Size for the Training Set:

• This is a non-clinical mechanical testing submission, not a machine learning or AI-driven device. Therefore, the concept of a "training set" is not applicable. The device itself is the physical implant, and its design and manufacturing are based on established engineering principles and materials science, not data-driven machine learning.

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

• Not applicable. As established in point 8, there is no "training set" in the context of this device's evaluation.

Ask a specific question about this device