(63 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® cannulated 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® SPINOUS PROCESS 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 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 modified multi axial screws to the CD HORIZON® Spinal System.
The provided document is a 510(k) summary for the CD HORIZON® Spinal System, a medical device. It describes the device, its indications for use, and states that it was found "substantially equivalent" to previously cleared devices.
Critically, this document does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics. 510(k) submissions for spinal fixation systems typically rely on demonstrating substantial equivalence to a predicate device, which involves comparing design, materials, indications for use, and often performing mechanical testing to ensure the device meets established engineering standards for strength, fatigue, and other biomechanical properties. However, these biomechanical tests are usually not included in the public 510(k) summary provided, nor do they typically report "device performance" in the clinical sense of diagnostic accuracy, sensitivity, or specificity.
Therefore, many of the requested fields cannot be filled directly from the provided text because these types of studies (e.g., those involving ground truth, expert readers, multi-reader multi-case studies, or standalone algorithm performance) are not applicable to the information presented in this 510(k) summary for a spinal implant.
Here's an attempt to answer as much as possible based on the provided text, while also noting what is not present:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Type of Performance) | Reported Device Performance |
|---|---|
| Clinical Performance (e.g., diagnostic accuracy, sensitivity, specificity) | Not applicable/Not reported in this 510(k) summary. The device is a spinal implant, not a diagnostic tool. Performance for such devices is typically evaluated through substantial equivalence to predicate devices, material testing, and biomechanical testing (e.g., fatigue, static strength), which are referenced but not detailed here. |
| Substantial Equivalence to Predicate Device | Documentation was provided which demonstrated the CD HORIZON® Spinal System to be substantially equivalent to CD HORIZON® Spinal System components previously cleared in K042025 and K011508. |
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable/Not reported for clinical performance. This 510(k) summary does not describe a "test set" of clinical data (e.g., images or patient outcomes) in the way a diagnostic algorithm would. Substantial equivalence is based on comparison to predicate devices and potentially non-clinical (e.g., mechanical) testing.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. There is no "ground truth" establishment described in the context of clinical performance data for this device in this document, as it's a spinal implant, not a diagnostic or screening tool.
4. Adjudication Method for the Test Set
- Not applicable. No test set or adjudication method for clinical performance is described.
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
- No. An MRMC comparative effectiveness study is not relevant for this type of device (spinal implant) and is not mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. For a spinal implant, "ground truth" in the sense of clinical performance metrics isn't established as it would be for a diagnostic device. The "truth" for substantial equivalence often relates to material properties, design specifications, and biomechanical performance meeting predetermined standards, as demonstrated by non-clinical testing.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/algorithm-based device. No training set is described.
9. How the Ground Truth for the Training Set was Established
- Not applicable. No training set or ground truth for it is described.
Summary of the Study (as described in the 510(k) submission):
The "study" described in this 510(k) summary is the process of demonstrating Substantial Equivalence to legally marketed predicate devices. This is the primary regulatory pathway for many Class II and some Class III medical devices.
- Device: CD HORIZON® Spinal System (modified multi-axial screws are the subject of this specific 510(k)).
- Methodology: The submission provided documentation to FDA demonstrating that the CD HORIZON® Spinal System, including the newly proposed modified multi-axial screws, is substantially equivalent in terms of materials, design, technological characteristics, and intended use to previously cleared CD HORIZON® Spinal System components (specifically referencing K042025 and K011508). This implies that the new components meet the same performance standards and have the same intended use as the previously cleared predicate devices. While not explicitly detailed in this summary, demonstrating substantial equivalence for spinal implants typically involves:
- Comparison of indications for use.
- Comparison of design features and materials.
- Mechanical testing (e.g., static and fatigue testing) to demonstrate that the new component's performance is equivalent to or better than the predicate device and meets international standards (e.g., ASTM or ISO standards for spinal implants).
- Biocompatibility assessments of materials.
- Outcome: The FDA reviewed the submission and determined that the device is "substantially equivalent" to the predicate devices for the stated indications for use, thereby allowing it to be legally marketed.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.