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The CD HORIZON® Spinal System with or without SEXTENT® instrumentation 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; pseudarthritis; 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.

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.

The CD HORIZON® SPIRE Plate is a 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 processes for the purpose of achieving supplemental fusion 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 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 thrugh 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 PLUMIS tolts; 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 prients 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 a sterile version of a previously cleared component to the CD HORIZON® Spinal System.

This document describes a 510(k) premarket notification for a medical device, the CD HORIZON® Spinal System, specifically for the addition of a sterile version of a previously cleared component, the CD HORIZON® ENGAGE Plate Threaded Nut Cap.

Therefore, the provided text does not contain the information requested regarding acceptance criteria, device performance, or a study involving a particular "device" in the context of AI, imaging, or diagnostics as implied by the format of the questions. The document is about substantial equivalence for a spinal fixation system component based on sterilization validation, not the performance of an AI or diagnostic device.

Here's why the questions cannot be answered based on the provided text:

• No new performance data: The submission is for a sterile version of an already cleared component. The core performance of the spinal system itself was established in previous submissions (K053101 and K061304). The current submission focuses on demonstrating that the sterilization process does not negatively impact the component.
• No AI or diagnostic device: The CD HORIZON® Spinal System is a mechanical implant for spinal fixation, not an algorithm, imaging device, or diagnostic tool.
• No "acceptance criteria" in the sense of accuracy/sensitivity/specificity: The "acceptance criteria" for this type of submission would relate to the validation of the sterilization process and confirmation that the sterile component meets the same material and functional specifications as the non-sterile version.
• No clinical trials or performance studies as described: The "study" mentioned is a "sterilization validation," not a clinical trial to evaluate diagnostic accuracy or human reader improvement with AI.

Summary of what can be gleaned from the document regarding the submission:

• Acceptance Criteria/Proof of Meeting: The acceptance criterion for this specific 510(k) was substantial equivalence to a previously cleared non-sterile version (K053101) of the CD HORIZON® ENGAGE Plate Threaded Nut Cap. The proof was "Documentation, including results from a sterilization validation."
• Study Type: Sterilization validation.
• Device: CD HORIZON® ENGAGE Plate Threaded Nut Cap (sterile version).
• Context: This is a 510(k) for a modification (sterilization) to an existing, cleared spinal implant component, not a new device requiring extensive performance studies on clinical efficacy or diagnostic accuracy.

Therefore, the requested table and detailed points about sample sizes, ground truth, expert qualifications, adjudication, MRMC studies, or standalone algorithm performance are not applicable to this specific 510(k) submission.

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