(78 days)
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® 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 screws to the CD HORIZON® Spinal System.
This document is a 510(k) premarket notification for the CD HORIZON® Spinal System. It asserts substantial equivalence to previously cleared devices. The document does not describe a study involving a device meeting acceptance criteria in the manner typically associated with AI/medical imaging device submissions (e.g., performance metrics, clinical trials).
Instead, it's a submission for a spinal implant system with the purpose of including "additional screws." The "acceptance criteria" here refer to regulatory acceptance for market clearance based on substantial equivalence, rather than performance criteria from a clinical trial or algorithm validation.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission.
Here's an interpretation based on the information provided, tailored to the type of device and submission:
1. Table of "Acceptance Criteria" (Regulatory) and Reported Device "Performance" (Substantial Equivalence Claim)
| Criteria Category | Specific Criteria / Claim | Reported "Performance" / Evidence |
|---|---|---|
| Regulatory Acceptance | Substantial Equivalence to predicate devices. | Documents demonstrated substantial equivalence to similar CD HORIZON® Spinal System components previously cleared in K042025 (SE 8/25/04) and K000094 (SE 02/08/00). |
| Intended Use/Indications | Device is for posterior, non-cervical fixation for specific spinal conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, failed previous fusion). | The current submission adds screws to the existing system, which maintains the previously cleared indications for use. Specific indications for anterior use and supplementary fixation via the SPIRE Plate are also reiterated. |
| Device Design/Components | Integrates with existing CD HORIZON® System components and other Medtronic Sofamor Danek spinal systems (TSRH®, GDLH®, LIBERTY®, DYNALOK PLUS®). | The new screws are intended to be part of the CD HORIZON® Spinal System, implying compatibility and integration with established components. |
2. Sample size used for the test set and the data provenance
Not Applicable. This submission is for additional components (screws) to an existing spinal system, asserting substantial equivalence based on prior clearances, not a performance study that would involve a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. See point 2.
4. Adjudication method for the test set
Not Applicable. See point 2.
5. 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 submission for a mechanical spinal implant system, not a diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a submission for a mechanical spinal implant system, with no algorithm or standalone performance testing mentioned or relevant.
7. The type of ground truth used
Not Applicable. The "ground truth" in this context is regulatory acceptance and the established safety and effectiveness of the predicate devices for their indicated uses, which the current device is asserted to be substantially equivalent to. This is based on mechanical testing and clinical experience with the predicate devices, not on data "ground truth" as one would evaluate an AI model.
8. The sample size for the training set
Not Applicable. This is not an AI device or a study involving a training set of data.
9. How the ground truth for the training set was established
Not Applicable. See point 8.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.