Search Results
Found 1 results
510(k) Data Aggregation
(50 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); 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. The CD HORIZON® Pediatric Spinal System is intended 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, CD HORIZON® SPIRE spinous process plate device, Shape Memory Alloy Staples, DYNALOK® bolts, and TSRH® screws and washers. 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 allov.
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 03.5mm, 04.5mm, 05.5mm rods or 06.35mm rods, while other components can connect to both Ø5.5mm rods and Ø6.35mm rods. 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 sinaller 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 hydroxyapatite.
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.
The purpose of this 510(k) was to add SEXTANT® 4.75mm diameter rods manufactured out of cobalt chrome and modified SEXTANT® and SEXTANT® reduction instruments to the CD HORIZON® Spinal System.
This is a 510(k) premarket notification for a medical device, the CD HORIZON® Spinal System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific performance acceptance criteria through clinical studies in the same way an AI/ML-driven diagnostic device would.
Therefore, many of the requested sections related to acceptance criteria, study design, ground truth, and AI/ML performance metrics are not applicable to this document. The document focuses on demonstrating substantial equivalence through design features, materials, and non-clinical testing.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics for the device. The "performance" demonstrated is substantial equivalence to predicate devices, primarily through design verification and validation activities.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (overall goal of 510(k)) | The subject devices (SEXTANT® 4.75mm diameter rods manufactured out of cobalt chrome and modified SEXTANT® and SEXTANT® reduction instruments) demonstrated substantial equivalence to previously listed predicate devices (CD HORIZON® Spinal System 5.5mm diameter rods (K042790, K052747) and 4.75mm diameter rods (K091974), and CD HORIZON® Spinal System instruments for use with 5.5mm diameter rods (K051674, K052747, K063417)). |
| Mechanical Integrity/Safety (implied for spinal implants) | "Non-clinical testing in the form of mechanical testing was not required for the subject rods since the only difference between them and the predicate rods was the modified tip geometry for the purposes of attaching to the subject SEXTANT® rod inserter and to aid in percutaneous implantation." |
| Compatibility with Instruments (implied for surgical tools) | "Non-clinical testing in the form of design verification and validation activities (tolerance stacks and cadaver lab) was performed on the subject devices to show equivalence to the previously listed predicate devices." |
| Risk Mitigation | "A risk analysis was completed for the changes incorporated into the subject devices." |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable in the context of this 510(k). The non-clinical testing mentioned involves "tolerance stacks and cadaver lab" (for instruments) and a rationale for not requiring mechanical testing for the rods due to minor design changes. These are not explicitly quantified as "sample sizes" in the way one would for a clinical study or an AI model’s test set.
- Data provenance: Not applicable. The "testing" referred to is internal design verification and validation, not data collected from patients or a specific geographical region.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of clinical outcomes or diagnostic accuracy, is not established for this type of device submission. The substantial equivalence relies on engineering and design principles, and comparison to already cleared predicate devices.
4. Adjudication method for the test set
Not applicable. There is no "test set" in the sense of patient data requiring adjudication.
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 not an AI/ML-driven device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML-driven device.
7. The type of ground truth used
Not applicable. No "ground truth" (expert consensus, pathology, outcomes data) in the context of diagnostic accuracy or clinical effectiveness is used or presented in this 510(k). The "truth" for this submission is that the modifications to the device (new rod material/size, modified instruments) do not alter its fundamental performance or safety compared to the predicate device.
8. The sample size for the training set
Not applicable. This is not an AI/ML-driven device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML-driven device.
Ask a specific question about this device
Page 1 of 1