Search Results

The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation 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.

When used in a percutaneous, non-cervical, posterior approach with the SEXTANT instrumentation, the CD HORIZON® screws are intended 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; pseudoarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, CD HORIZON® components such as ECLIPSE® components are intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The CD HORIZON® SPIRE Plate is posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 – S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: 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); 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 rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.

The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The CD HORIZON® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the CD HORIZON® Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.

Certain implant components from other Medtronic Sofamor Danek spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washers; GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNALOK PLUS® bolts; and Medtronic Sofamor Danek Multi-Axial rods and screws.

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

The purpose of this 510(k) submission is to add modified 5.5mm and 6.35mm diameter cobalt-chromium-molybdenum rods, and set screws to the CD HORIZON® Spinal System.

Here's a breakdown of the acceptance criteria and study information for the CD HORIZON® Spinal System based on the provided text.

This document describes a 510(k) submission for modifications to an existing spinal system, primarily focusing on adding new rod and set screw components. The "study" mentioned here refers to mechanical testing for substantial equivalence, not a clinical trial or algorithm performance study as typically understood for AI/software devices. Therefore, many of the requested points regarding AI/algorithm performance are not applicable.

Acceptance Criteria and Device Performance (Mechanical Testing)

Study Details (Focusing on Mechanical Testing for Substantial Equivalence)

Since this is a submission for a physical medical device (spinal system components) and not an AI/software device, many of the typical AI-related study questions are not applicable.

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

   • Sample Size: Not specified in the provided text. The testing would involve a sufficient number of samples of the newly introduced components (5.5mm and 6.35mm diameter cobalt-chromium-molybdenum rods and set screws) and predicate components to perform comparative mechanical characterization.
   • Data Provenance: The nature of the study (mechanical testing) indicates the "data" would be generated in a lab setting. The company, Medtronic Sofamor Danek, Inc., is based in the USA.

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

   • Not applicable. For mechanical testing, "ground truth" is established by engineering standards and validated testing protocols rather than expert human interpretation. The testing would be conducted by qualified engineers or technicians.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are for expert consensus in clinical contexts. Mechanical test results are quantitative and compared against predefined engineering specifications or predicate device performance.

4. 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 physical device, not an AI or imaging diagnostic tool. An MRMC study is irrelevant here.

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

   • Not applicable. This device does not involve an algorithm.

6. The Type of Ground Truth Used:

   • For mechanical testing, the "ground truth" would be established by engineering specifications, industry standards (e.g., ASTM, ISO for spinal implants), and the established performance characteristics of the predicate devices. The goal is to demonstrate that the new components perform equivalently or better in terms of mechanical properties (e.g., strength, fatigue, stiffness).

7. The Sample Size for the Training Set:

   • Not applicable. This is not a machine learning model. There is no "training set."

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

   • Not applicable. As above, no training set is involved.

Summary of the 510(k) Submission:

The provided document K043488 is for a modification to an existing spinal implant system, the CD HORIZON® Spinal System. The primary purpose of this specific 510(k) was to add modified 5.5mm and 6.35mm diameter cobalt-chromium-molybdenum rods and set screws. The demonstration of safety and effectiveness for such modifications typically relies on mechanical testing to show that the new components are substantially equivalent to previously cleared predicate devices and meet the same performance standards. The FDA's clearance confirms this substantial equivalence.

Ask a specific question about this device