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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, 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 include additional stainless steel components to the CD HORIZON® Spinal System.

This document describes the CD HORIZON® Spinal System, specifically the addition of stainless steel components for 6.35mm rods (K041118). It is a spinal implant system used for internal fixation as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.

However, the provided text does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications in the context of typical AI/software device evaluation.

Instead, the document focuses on:

• Product Description: Detailing the components and general use of the CD HORIZON® Spinal System.
• Indications for Use: Listing the specific medical conditions for which the device is intended (e.g., degenerative disc disease, spondylolisthesis, trauma, scoliosis, tumor, pseudarthrosis, failed fusion).
• Substantial Equivalence: Stating that the device was found substantially equivalent to previously cleared titanium and stainless steel versions of the same components (K040583 and K034056). This is the primary "study" or justification for clearance mentioned.
• Regulatory Clearance: The FDA's letter confirming substantial equivalence to predicate devices.

Therefore, I cannot populate the requested table and answer the study-related questions as the information is not present in the provided text. The document describes a traditional medical device (implantable hardware), not a software or AI-based diagnostic/therapeutic device that would typically undergo the detailed performance studies you are asking about (e.g., test sets, ground truth, expert adjudication, MRMC studies, standalone performance).

No information regarding acceptance criteria, reported device performance (in terms of sensitivity/specificity/accuracy), sample sizes for test/training sets, data provenance, expert ground truth, or adjudication methods is available in the provided text. The clearance relies on substantial equivalence to predicate devices, not on a new clinical study demonstrating specific performance metrics against a defined ground truth in the way a diagnostic algorithm would.

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