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The CD HORIZON® Spinal System with or without SEXTANT® 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); 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 (TI-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.

When used as a pedicle screw fixation system in skeletally mature patients, the CD HORLZON® AGILE™ Dynamic Stabilization device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the degenerative spondylolisthesis with objective evidence of neurologic impairment and/or failed previous fusion in the thoracic, lumbar and/or sacral spine. Additionally, when used as a pedicle screw fixation system, the CD HORIZON® AGILE™ Dynamic Stabilization device is indicated for use in patients who are receiving fusions with autogenous graft only; who are having the device fixed or attached to the lumbar or sacral spine; and/or are having the device removed after the development of a solid fusion mass.

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 VERTF.X™ Reconstruction System through a rod connector.

Certain implant components from other Medironic Sofamor Danek spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, stapies 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 CD HORIZON® AGILE™ Dynamic Stabilization device is comprised of four components and is comprised by a combination of materials. The proximal and distal rod components arc manufactured from commercially pure titanium. The cable is fabricated from a 7x7 filament yarn made from titanium alloy, with a cylinder rotary-swaged to the end, made from the same material. The spacer portion of the device is manufactured from Polycarbonate-Urethane.

The purpose of this 510(k) submission is to include additional CD HORIZON® SEXTANT® instruments to the CD HORIZON® Spinal System.

This document is a 510(k) summary for the CD HORIZON® Spinal System, a medical device. 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance metrics of the device itself in the way an AI/software device often would.

Therefore, the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are common for evaluations of AI or diagnostic software, is not present in this regulatory submission for a physical spinal implant system.

This 510(k) focuses on demonstrating that the updated CD HORIZON® Spinal System (specifically the inclusion of additional SEXTANT® instruments) is substantially equivalent to previously cleared predicate devices for the same indications for use.

Here's an explanation of why the requested information isn't available in this document:

• No Acceptance Criteria for Device Performance: For a physical implant like a spinal system, "acceptance criteria" generally relate to manufacturing specifications, material properties, mechanical testing (e.g., fatigue, strength), biocompatibility, and sterilization, rather than diagnostic accuracy metrics. This 510(k) doesn't detail those specific engineering or biological acceptance criteria.
• No "Study" in the AI/Diagnostic Sense: The determination of substantial equivalence relies on comparing the new device's design, materials, indications, and performance to a predicate device that has already been cleared. It doesn't involve a prospective clinical study to prove the device meets specific performance criteria against a clinical ground truth in the way a diagnostic algorithm would.
• No Test Sets, Training Sets, or Ground Truth: These concepts relate to the evaluation of algorithms or diagnostic tools where performance is measured against a known "truth." For a spinal implant, the "performance" is its ability to provide immobilization and stabilization as an adjunct to fusion, and its safety. This is typically assessed through comparison to existing marketed devices with a known safety and efficacy profile, and potentially bench testing.
• No Experts for Ground Truth/Adjudication: The regulatory review for this type of device involves evaluating the design, materials, manufacturing processes, and indications against FDA regulations and known predicate devices. It doesn't involve clinicians establishing a "ground truth" on individual cases to assess the device's diagnostic accuracy.
• No MRMC or Standalone Performance: These are terms used for evaluating diagnostic performance, which is not the primary function of a spinal implant.

What the document does state regarding "performance" and "equivalence" (which is the substitute for a formal "study" in this context):

The document mentions:

• "Documentation, including a risk analysis, was provided which demonstrated the subject instruments to be substantially equivalent to the predicate CD HORIZON® SEXTANT® instruments previously cleared in K051674 (SE 07/21/05) for the same indications." (Page 2, Section VI)
• It also references previous 510(k) clearances for the condensed CD HORIZON® Spinal System indications (K061304) and the CD HORIZON® AGILE™ Dynamic Stabilization device indications (K060615). (Page 2, Section VI)

In summary, this 510(k) submission is for a physical medical device (spinal implant components) and therefore does not contain the types of performance data, study designs, or expert evaluations typically described for AI or diagnostic software. Its clearance is based on demonstrating substantial equivalence to predicate devices, implying similar safety and efficacy profiles.

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