(62 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 and/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® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. These devices are to be used with autograft and/or allograft. 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 (TI-SI) 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.
Certain components within the CD HORIZON® Spinal System are specifically excluded for use in pediatric patients. These include PEEK rods. Shape Memory Alloy Staples, SPIRE™ Plates and DYNALOK® bolts. All screws used in pediatric cases are only cleared for use via a posterior approach. All of the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, and medical grade cobalt-chromium-molybdenum alloy.
Certain implant components from other Medtronic spinal systems can be used with the CD HORIZON® Spinal System in non-pediatric cases. These components include TSRH® rods, hooks, screws, plates. CROSSLINK® plates, connectors, staples, washers, GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNALOK® PLUS and DYNALOK CLASSIC® bolts along with rod/bolt connectors; and Medtronic Multi-Axial rods and screws. Please note that certain components are specifically designed to connect to specific rod diameters, while other components can connect to multiple rod diameters. Care should be taken so that the correct components are used in the spinal construct.
CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and associated screws are intended for anterior use only. However, for patients of smaller stature and pediatric patients, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.
The CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, medical grade cobaltchromium-molybdenum alloy, or medical grade PEEK OPTIMA-LT1. Certain CD HORIZON® Spinal System components may be coated with hydroxvapatite. No warranties expressed or implied are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MDT Catalog for further information about warranties and limitations of liability.
Never use stainless steel and titanium implant components in the same construct.
Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromiummolybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct.
The CD HORIZON® Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt-chromium-molybdenum alloy. Do not use with stainless steel. These staples are not to be used in pediatric patients.
PEEK OPTIMA-LT1 implants may be used with stainless steel, titanium, or cobaltchromium-molybdenum alloy implants. CD HORIZON® PEEK Rods are not to be used with CROSSLINK® Plates or in pediatric patients.
To achieve best results, do not use any of the CD HORIZON® Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all orthopaedic and neurosurgical implants, none of the CD HORIZON® Spinal System components should ever be reused under any circumstances.
The purpose of this 510(k) was to add additional non-sterile hooks to the CD HORIZON® Spinal System. The subject hooks along with other components such as metal rods, screws, and other connecting components are intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of thoracic, lumbar, and/or sacral spine. The subject hooks are manufactured out of medical grade titanium alloy.
Here's an analysis of the provided text regarding the CD HORIZON® Spinal System, focusing on the requested information:
Note: The provided document is a 510(k) summary, which is a premarket notification for medical devices. The purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically involves demonstrating equivalent performance through non-clinical (e.g., mechanical) testing rather than full clinical trials with human subjects. Therefore, many of the typical acceptance criteria and study elements associated with AI/software devices (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance of an algorithm) are not applicable to this device and document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Mechanical Equivalence to Predicate Devices | The subject hooks (new non-sterile hooks) have identical head geometries to the predicate 5.5mm/6.0mm FAS (Fixed Angle Screws) cleared in K113174. They also accommodate the same size rods. The rod interfacing geometry is identical. | This is the primary "acceptance criterion" for a 510(k) in this context – demonstrating that the design and mechanical properties are equivalent to already cleared devices. |
| Material Equivalence | The subject hooks are manufactured out of medical grade titanium alloy, consistent with materials used in predicate devices. | The document emphasizes that materials (medical grade stainless steel, titanium, titanium alloy, cobalt-chromium-molybdenum alloy, PEEK OPTIMA-LT1) are the same as predicate devices. Specific cautions about mixing materials are also noted. |
| Design Feature Equivalence | The subject devices provide additional fixation options for connecting to both 5.5mm and 6.0mm diameter rods. The primary change from predicate hooks is this dual-rod size compatibility, while materials, blade geometry, head geometry, thread forms, surface finish, and sizes are otherwise the same. | The change is noted as an enhancement in compatibility while maintaining otherwise equivalent design characteristics. |
| Non-Clinical Testing Applicability | Results of interconnection mechanical testing performed on predicate 5.5/6.0mm FAS (K113174) are deemed applicable and considered equivalent to the subject hooks due to identical rod interfacing geometry. The subject hooks do not introduce a new worst-case scenario. | This indicates that new mechanical testing was not performed for this specific 510(k) submission, as the previous testing on a substantially equivalent predicate was considered sufficient. |
| Risk Analysis | Risk analysis for the modified components was completed. | The specific outcomes of the risk analysis are not detailed, but its completion is stated as a basis for substantial equivalence. |
2. Sample Size Used for the Test Set and the Data Provenance
- Not applicable. This document describes a medical device (spinal system components, specifically hooks), not a software or AI device that would undergo testing on a "test set" with "data provenance" in the traditional sense. The "testing" referred to is mechanical testing of physical implants. The document explicitly states, "The results of the non-clinical testing (interconnection mechanical testing) performed on the predicate 5.5/6.0mm FAS cleared in K113174 are deemed applicable and considered equivalent to the subject hooks as their rod interfacing geometry is identical." This implies that no new mechanical testing on the subject device was performed for this 510(k), rather, existing test data from a predicate device was leveraged.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. As above, this document concerns mechanical stability and material compatibility of physical implants, not the performance of an AI algorithm requiring expert-established ground truth.
4. Adjudication Method for the Test Set
- Not applicable. There is no "test set" requiring adjudication in the context of this 510(k) submission for a spinal implant.
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. This is a hardware device (surgical implant), not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies are entirely irrelevant and were not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- No. This is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
- Mechanical Testing Results & Engineering Specifications: The "ground truth" for this device's performance relies on engineering principles, material science, and the results of established mechanical tests (e.g., fatigue testing, static strength testing) on similar devices (the predicates) or the specific components, ensuring they meet biomechanical requirements for spinal fixation. The comparison is made against the performance of legally marketed predicate devices.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set, there is no ground truth establishment for it. The design of the CD HORIZON® Spinal System components is based on established biomechanical principles and compatibility with existing surgical techniques and implants.
§ 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.