(77 days)
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion 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, or lordosis), tumor, pseudarthrosis. 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 as an adjunct to fusion.
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 as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation 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 shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations with each construct being tailor-made for the individual case.
A subset of CD HORIZON® Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, CROSSLINK® Plates and connecting components. Similarly to the CD HORIZON® implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
The purpose of this submission is to add additional components to the CD HORIZON® Spinal System, specifically multi-axial screws (MAS), fixed angled Screws (FAS), and break-off set screws (BOSS).
The subject devices are intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and /or sacral spine. The multi-axial screw is a polyaxial screw, which allows the screw to be angled in any direction. This feature makes it easier for the surgeon to implant rods. The fixed angle screw is a monoaxial screw, which is used when the surgeon needs a more rigid construct. The break-off set screw is used with both the multi-axial screw and fixed angle screw to tighten the rod into the screw head.
The subject devices are manufactured from titanium alloy or titanium alloy/ commercially pure titanium, per ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Allov for Surgical Implant Applications and ASTM F67-13 - Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700), which are identical to the materials used to manufacture the predicate devices.
The subject multi-axial screws, fixed angle screws, and break-off set screws are implants that are single use only. The subject multi-axial screws, fixed angle screws, and break-off set screws are provided non-sterile and steam sterilized by the hospital. Additionally, the subject multi-axial screws and break-off set screws are also provided sterile by gamma irradiation.
This document describes the premarket notification (510(k)) for the Medtronic CD HORIZON® Spinal System, specifically for additional components: multi-axial screws (MAS), fixed angled screws (FAS), and break-off set screws (BOSS).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Evaluation | Acceptance Criteria (Pre-determined) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Compatibility with biological systems | Long history of safe and effective use of materials in predicate spinal implants. | Manufactured from titanium alloy or titanium alloy/commercially pure titanium (ASTM F136-13, ASTM F67-13), identical to predicate devices. |
| Mechanical Testing | Axial Grip | Met pre-determined criteria | Met pre-determined criteria |
| Mechanical Testing | Axial Torsion | Met pre-determined criteria | Met pre-determined criteria |
| Mechanical Testing | Flexion Extension Static Testing | Met pre-determined criteria | Met pre-determined criteria |
| Mechanical Testing | Flexion Extension Fatigue | Met pre-determined criteria | Met pre-determined criteria |
| Mechanical Testing | Construct Static Compression Bending | Met pre-determined criteria | Met pre-determined criteria |
| Mechanical Testing | Construct Static Torsion | Met pre-determined criteria | Met pre-determined criteria |
| Mechanical Testing | Construct Compression Bending Fatigue | Met pre-determined criteria | Met pre-determined criteria |
Note: The document explicitly states "The subject devices met the pre-determined acceptance criteria for all tests." It does not provide the specific numerical values of these criteria or the test results themselves, but confirms all criteria were met.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact number of implants or constructs tested for the mechanical evaluations. It refers to "the subject devices" and indicates that "testing was completed."
- Data Provenance: The mechanical testing was conducted by Medtronic, the device manufacturer, in accordance with FDA guidance and ASTM standards. The data is prospective, generated specifically for this 510(k) submission. No country of origin for the data is specified beyond the manufacturer's location in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable (N/A) to this type of device submission. The "ground truth" for mechanical testing is established by engineering standards (ASTM F1717, ASTM F1798) and predefined acceptance criteria, not by expert human interpretation of medical images or outcomes.
4. Adjudication Method for the Test Set
This information is not applicable (N/A). Mechanical testing of physical devices does not typically involve adjudication in the way clinical studies with human readers do. The results are objective measurements against defined standards.
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
This information is not applicable (N/A). This submission is for a spinal implant system, not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable (N/A). As mentioned, this is a physical medical device, not an algorithm, so standalone performance in that context is not relevant.
7. The Type of Ground Truth Used
For Biocompatibility: The ground truth is the established safety and efficacy profiles of the constituent materials (titanium alloy and commercially pure titanium) in long-term surgical implant applications, as supported by their conformity to ASTM standards (ASTM F136-13 and ASTM F67-13) and historical use in legally marketed predicate devices.
For Mechanical Testing: The ground truth is established by the ASTM standards (ASTM F1717 - Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, and ASTM F1798 - Standard Guide to Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants) and the pre-determined acceptance criteria derived from these standards and FDA guidance ("Guidance for Industry and FDA Staff - Spinal System 510(k)'s").
8. The Sample Size for the Training Set
This information is not applicable (N/A). This is a physical medical device submission, not an AI/machine learning submission. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set was Established
This information is not applicable (N/A) for the same reasons as point 8.
§ 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.