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510(k) Data Aggregation

    K Number
    K211958
    Device Name
    CD Horizon Spinal System
    Manufacturer
    Medtronic Sofamor Danek USA, Inc.
    Date Cleared
    2021-07-21

    (27 days)

    Product Code
    NKB,KWP,KWQ
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K210637,K201407,K182119,K042025
    Why did this record match?
    Reference Devices :

    K210637, K201407

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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 (DDD - 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, tumor, pseudarthrosis, and/or failed previous fusion.

    Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion. With the exception of DDD, CD Horizon™ 3.5mm rods and associated components may be used for indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediativ indications noted.

    When used for posterior non-cervical pedicle screw fixation in pediatric patients. CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, and congenital scoliosis, Additionally, the CD Horizon™ 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™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. Devices are intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

    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: DDD, spondylolisthesis, trauma, and/or tumor.

    To achieve additional levels of fixation, 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 Vertex™ indications.

    Device Description

    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 3.5 to 6.35mm), hooks, screws, Crosslink™ plates and connecting components. Similar 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. Screws used in pediatric cases are only cleared for use via a posterior approach. 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 and 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. Note: 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 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.

    CD Horizon™ Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, medical grade cobalt-chromium-molybdenum alloy, or medical grade PEEK Optima-LT1. Certain CD Horizon™ Spinal System components may be coated with hydroxyapatite. No warranties, expressed or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.

    Never use stainless steel and titanium implant components in the same construct.

    Medical grade titanium, titanium alloy, and/or medical grade cobaltchromium-molybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt-chromiummolybdenum 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 cobaltchromium-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 titanium or cobaltchromium-molybdenum alloy implants. CD Horizon™ PEEK rods are not to be used in pediatric patients. PEEK rods are only to be used with the associated pedicle screws as well as interbody fusion devices in the anterior spinal column.

    To achieve best results, do not use 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 changes/ modifications to the CD Horizon™ Spinal System presented in this submission are:

    • . Introduction of Revision Connectors which have modifications to the primary predicate device geometry offering additional options for rod size and screw trajectory connections.
    • Cross-compatibility is presented for use of the insertion devices presented in K210637 (S.E. 04/30/2021) for use with implants presented in K201407 (S.E. 09/10/2020).
    AI/ML Overview

    This document is a 510(k) premarket notification for the Medtronic CD Horizon™ Spinal System, specifically addressing the introduction of "Revision Connectors" and cross-compatibility of insertion devices. The document asserts substantial equivalence to previously cleared predicate devices.

    Here's an analysis of the acceptance criteria and study information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific CriteriaReported Device Performance/Evidence
    Mechanical PerformanceDemonstrated equivalent or superior mechanical performance to predicate devices to ensure safety and efficacy under intended use conditions. This would typically involve testing for strength, fatigue, and other relevant mechanical properties."Medtronic performed confirmatory mechanical testing per ASTM F1798 and ASTM F1717 and a risk analysis in comparison to predicate devices. Both evaluations demonstrated that the subject devices do not introduce a new worst case to the CD Horizon™ Spinal System product families."
    BiocompatibilityThe materials used for the new components must be biocompatible and not elicit an adverse biological response when implanted in the human body for an extended period. This usually involves testing according to ISO 10993 standards."The subject implants are manufactured from identical materials as the predicate devices, in accordance with the following standards: ASTM F136 Standard Specification for Wrought Titanium -6Aluminum – 4Vanadium ELI (Extra-Low-Interstitial) Alloy for Surgical Implants. The materials used for manufacturing the subject device have a long history of safe and effective use identical to predicate devices and biocompatibility testing is not required."
    Indications for UseThe indications for use for the modified device (Revision Connectors and insertion device cross-compatibility) must be identical to or fall within the scope of the predicate devices."The subject CD Horizon™ Spinal System Revision Connector implants have the same indications, intended use... as the previously FDA cleared predicates CD Horizon™ Spinal System K210637... The indications for use for the subject connector devices are identical to the previously cleared CD Horizon™Spinal System K210637 (S.E. 04/30/2021)."
    Regulatory EquivalenceThe modified device must be substantially equivalent to a legally marketed predicate device with respect to intended use, technology, and safety/effectiveness, without raising new questions of safety or effectiveness.The core of the 510(k) submission is to demonstrate this. The conclusion states: "Based on the supporting information provided in this pre-market notification, the subject CD Horizon™ Spinal System Revision Connector implants are substantially equivalent to the following predicates: Primary Predicate: CD Horizon™ Spinal System K182119 (SE 08/29/2018), Additional Predicate 1: CD Horizon™ Spinal System K042025 (SE 08/25/2004), Additional Predicate 2: CD Horizon™ Spinal System K210637(SE 04/30/2021)."

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size for Test Set: The document does not specify sample sizes for the mechanical testing (ASTM F1798 and ASTM F1717). These standards typically outline the number of samples required for each test type (e.g., static bending, fatigue).
    • Data Provenance: The mechanical testing and risk analysis were performed by Medtronic ("Medtronic performed confirmatory mechanical testing..."). The provenance of the data is therefore internal to the company, conducted as part of their regulatory submission for the U.S. FDA. The data is based on prospective testing of the new and predicate device components.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

    • This information is not applicable to this type of submission. The ground truth for mechanical testing of spinal implants is established by engineering standards (ASTM F1798, ASTM F1717) and material specifications (ASTM F136), not by human expert consensus or clinical evaluations in the context of this 510(k). This is a purely engineering and materials-based assessment for hardware.

    4. Adjudication Method for the Test Set

    • This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in clinical or image-based expert reviews. For mechanical testing, the "adjudication" is inherent in successfully meeting the specified requirements of the ASTM standards and demonstrating equivalence in the risk analysis.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    • No, an MRMC comparative effectiveness study was not done. This document pertains to the mechanical and material aspects of spinal implant components, not to diagnostic algorithms or AI-assisted clinical interpretations that would involve human readers.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    • No, a standalone algorithm performance study was not done. This submission is for mechanical spinal implants, not for an algorithm or AI device.

    7. The Type of Ground Truth Used

    • The "ground truth" for this device's acceptance is based on:
      • Engineering Standards: Defined mechanical properties and performance criteria as outlined in ASTM F1798 and ASTM F1717.
      • Material Specifications: Compliance with ASTM F136 for material composition and properties.
      • Predicate Device Performance: The established, legally marketed safety and effectiveness profile of the predicate devices. The new device must perform equivalently or better than the predicates.

    8. The Sample Size for the Training Set

    • This information is not applicable. This is not an AI/machine learning device that would require a "training set." The development of these mechanical components relies on engineering design principles, material science, and manufacturing processes, not data-driven model training.

    9. How the Ground Truth for the Training Set Was Established

    • This information is not applicable as there is no "training set" for this type of medical device.
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