(29 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, 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 titanium M8 and M10 Fixed Angled Screw components to the CD HORIZON® Spinal System.
This is a 510(k) premarket notification for the CD HORIZON® Spinal System. This type of submission is a declaration of "substantial equivalence" to a predicate device, meaning it is substantially as safe and effective as a device already legally marketed. It does not typically involve the kind of rigorous clinical studies with specific acceptance criteria and performance metrics that would be associated with a novel device or a PMA (Premarket Approval) application.
Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, or comparative effectiveness studies.
Specifically:
- A table of acceptance criteria and the reported device performance: Not present. The document focuses on demonstrating equivalence, not on establishing and meeting performance criteria from a new study.
- Sample sized used for the test set and the data provenance: Not present. There is no mention of a test set with human or animal data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no test set or ground truth established in this context.
- Adjudication method: Not applicable.
- 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 not an AI device, and no MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical implant, not an algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable. This is not an AI device trained on data.
- How the ground truth for the training set was established: Not applicable.
Summary of the Document's Approach:
The document demonstrates substantial equivalence by:
- Product Description: Detailing the components and intended use of the CD HORIZON® Spinal System.
- Indications for Use: Clearly outlining the conditions for which the device is intended (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, failed previous fusion), and specifying different approaches (posterior, percutaneous, anterolateral) and specific components (SPIRE Plate, connection to VERTEX™ Reconstruction System).
- Substantial Equivalence Claim: Stating that documentation was provided to demonstrate the CD HORIZON® Spinal System is substantially equivalent to previously cleared components (K011508) of the same system.
The FDA's decision letter (K041460 letter) confirms that the device was found substantially equivalent to legally marketed predicate devices, allowing it to proceed to market under the general controls, without requiring a premarket approval application (PMA). This process does not involve the type of performance evaluation criteria you've outlined.
§ 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.