Search Results

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, 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 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™ Legacy™ 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 pediatric 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, 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 and/or allograft. 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.

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.

This document, K233951, is a 510(k) premarket notification for the CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw). It is a notification demonstrating substantial equivalence to previously cleared predicate devices, not a study for a new device with new acceptance criteria and a detailed clinical trial. Therefore, most of the requested information regarding acceptance criteria, study details, and AI performance is not applicable to this type of submission.

Here's a breakdown of the relevant information provided and why other requested details are absent:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (General): The acceptance criteria for this type of submission are typically that the new device does not present a "new worst case" compared to the predicate devices and meets established ASTM standards for spinal implants. The document explicitly states: "For the tested subject devices, the pre-determined acceptance criteria was met for all tests."
   • Reported Device Performance: The performance data reported is primarily through engineering bench testing according to existing ASTM standards for spinal implants. The document indicates that for tested devices, acceptance criteria were met. For rationalized devices (those where new testing was deemed unnecessary because they do not present a new worst case), the existing predicate data applies.

   Acceptance Criteria (Type)	Reported Device Performance
   ASTM F1717: Static Compression, Static Torsion, Compression Fatigue (Relevant for spinal system components)	Met pre-determined acceptance criteria for all tested devices.
   ASTM F1798: Axial Grip, Axial Torsion, Flexion Extension Static, Flexion Extension Fatigue Screw Reduction to Failure Testing (Relevant for pedicle screw systems)	Met pre-determined acceptance criteria for all tested devices.
   ASTM F2503: MRI Compatibility Evaluation	Met pre-determined acceptance criteria for all tested devices.
   Device does not present a "new worst case" compared to predicate devices (for rationalized devices). This implies that the performance characteristics (mechanical strength, material compatibility, etc.) are equivalent to or better than the predicate devices, as demonstrated by the existing predicate data or engineering analysis. The subject devices have the same intended use, indications for use, materials, similar overall design, fundamental technology, sterilization, and surgical technique as the predicate devices. The subject and predicate implants have the same function and fundamental scientific technology.	Applicable (existing predicate data is applicable).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • This document refers to bench testing (mechanical, material, MRI compatibility). The "sample size" for such testing is generally a number of physical specimens tested to meet statistical power for engineering analysis, not a patient-based test set as in clinical studies. The document does not specify the exact number of physical samples for each test (e.g., how many screws were tested for axial grip).
   • Data Provenance: This is engineering test data, not patient data. Therefore, concepts like "country of origin of the data," "retrospective," or "prospective" are not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not applicable. This is an engineering test of spinal implant components, not an AI or diagnostic device requiring expert interpretation of medical images or patient data to establish ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. Adjudication methods are used in clinical studies or performance studies where multiple readers or experts assess outcomes. This is bench testing.

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:

   • Not applicable. This is a spinal implant device, not an AI or diagnostic software. Therefore, an MRMC study or AI assistance is not relevant to this submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a physical medical device, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable in the clinical sense. For mechanical testing, the "ground truth" is defined by the physical limits and standards outlined in the ASTM protocols (e.g., a screw must withstand a certain load without failure, or a material must not show adverse reactions in an MRI environment).

8. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

   • Not applicable. As above, no training set for an AI/ML model is involved.

Summary of the 510(k) Submission:

This 510(k) submission for the CD Horizon ModuLeX Spinal System focuses on demonstrating substantial equivalence to existing predicate devices already on the market. The primary "study" involved is a series of bench tests (mechanical and MRI compatibility) conducted according to established ASTM standards (F1717, F1798, F2503) for spinal implants. The key "acceptance criterion" for these tests is simply meeting the pre-determined specifications of these standards, and the document states that these criteria were met for all tested devices. For components not subjected to new testing, the justification ("rationalization") relies on the fact that they do not present a "new worst case" compared to previously cleared predicate devices, implying their performance aligns with the existing, cleared data. This type of submission does not involve clinical studies or AI performance evaluations.

Ask a specific question about this device