The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation 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 and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used in a percutaneous, non-cervical, posterior approach with the SEXTANT instrumentation, the CD HORIZON® screws are intended 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 and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, CD HORIZON® components such as ECLIPSE® components are intended for the following indications: ( ) ) degenerative disc discase (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis. (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The CD HORIZON® SPIRE Plate is posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 – S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies; spondylolisthesis; trauma (i.c., fracture or dislocation); and/or tumor.

The CD HORIZON® LEGACY 3.5mm rod and associated components, when used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, are indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the CD HORIZON® LEGACY 3.5mm rod and associated components, are indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (1,3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a pedicle screw system in skeletally mature patients, the CD HORIZON® Spinal System PEEK rods and associated components are intended to provided immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar and sacral spine: ( i ) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) kyphosis, and/or (3) failed previous fusion. Additionally, when used as a pedicle screw device, the CD HORIZON® Spinal System PEEK rod constructs are indicated for use in patients who: (1) are receiving fusion with autogenous graft only. (2) who are having the device attached to the lumbar or sacral spine, and/or (3) who are having the device removed after the development of a solid fusion mass.

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.

Device Description

The CD HORIZON® Spinal System consists of a variety of rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.

The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The CD HORIZON® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the CD HORIZON® Spinal System can be connected to the VERTEX™ Rcconstruction System through a rod connector.

Certain implant components from other Medtronic Sofamor Danek spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks. screws, plates, CROSSLINK® plates, connectors, staples and washers; GDI.H® rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNALOK PLUS® bolts; and Medtronic Sofamor Danek Multi-Axial rods and screws.

CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and screws are intended for anterior use only. However, for patients of smaller stature, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.

The purpose of this 510(k) submission is to add PEEK rods as well as modified titanium alloy screws to the CD HORIZON® Spinal System.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the CD HORIZON® Spinal System, specifically for the addition of PEEK rods and modified titanium alloy screws. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a clinical study with detailed performance metrics and acceptance criteria as would be found in a study for a new device requiring extensive clinical validation.

Therefore, the information typically requested in your prompt (e.g., sample sizes for test/training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, specific ground truth types) is not present in this type of regulatory submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Mechanical Equivalence to Predicate Devices: (Implied: Mechanical properties, such as strength, durability, and biocompatibility, of the PEEK rods and modified titanium alloy screws are at least equivalent to those of the predicate CD HORIZON® components and the DYNESYS Spinal System.)	Demonstrated through mechanical test reports: "Documentation, including a mechanical test reports and a risk analysis, was provided which demonstrated the subject rods and screws to be substantially equivalent to predicate CD HORIZON® components previously cleared in K043488, K041862, K042962, K000094, K042025, K032033, K043151 and K021791. Additionally documentation, including mechanical test reports, were provided to demonstrate that the subject rods are substantially equivalent to the previously cleared DYNESYS Spinal System (K031511, SE 03/05/04) for identical indications."
Substantial Equivalence in Intended Use/Indications: (Implied: The PEEK rods and modified titanium alloy screws can be safely and effectively used for the same indications as the predicate devices.)	Indicated through FDA's 510(k) clearance: The FDA reviewed the submission and determined that "the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." The indications for use listed for the CD HORIZON® Spinal System (including PEEK rods and modified titanium alloy screws) are consistent with those of previously cleared devices.

Acceptance Criteria

Reported Device Performance

Mechanical Equivalence to Predicate Devices: (Implied: Mechanical properties, such as strength, durability, and biocompatibility, of the PEEK rods and modified titanium alloy screws are at least equivalent to those of the predicate CD HORIZON® components and the DYNESYS Spinal System.)

Demonstrated through mechanical test reports: "Documentation, including a mechanical test reports and a risk analysis, was provided which demonstrated the subject rods and screws to be substantially equivalent to predicate CD HORIZON® components previously cleared in K043488, K041862, K042962, K000094, K042025, K032033, K043151 and K021791. Additionally documentation, including mechanical test reports, were provided to demonstrate that the subject rods are substantially equivalent to the previously cleared DYNESYS Spinal System (K031511, SE 03/05/04) for identical indications."

Substantial Equivalence in Intended Use/Indications: (Implied: The PEEK rods and modified titanium alloy screws can be safely and effectively used for the same indications as the predicate devices.)

Indicated through FDA's 510(k) clearance: The FDA reviewed the submission and determined that "the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." The indications for use listed for the CD HORIZON® Spinal System (including PEEK rods and modified titanium alloy screws) are consistent with those of previously cleared devices.

2. Sample size used for the test set and the data provenance:

Not Applicable / Not Provided. This submission relies on engineering and mechanical testing data for substantial equivalence, not clinical test set data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable / Not Provided. Ground truth as a clinical diagnosis from experts is not relevant in an engineering substantial equivalence submission.

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

Not Applicable / Not Provided.

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 medical device (spinal implant) with no AI component, so MRMC studies are irrelevant.

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

Not Applicable. This is a medical device (spinal implant) with no AI component.

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

For the mechanical testing performed, the "ground truth" would be established by engineering standards and specifications for material properties and mechanical performance. This is implied by the "mechanical test reports" mentioned.

8. The sample size for the training set:

Not Applicable / Not Provided. There is no "training set" in the context of an engineering substantial equivalence assessment for a spinal implant.

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

Not Applicable / Not Provided.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" in this context is a substantial equivalence demonstration based on mechanical testing and analysis, rather than a clinical trial.

Objective: To demonstrate that the newly added PEEK rods and modified titanium alloy screws to the CD HORIZON® Spinal System are substantially equivalent to existing, legally marketed predicate devices.
Methodology:
- Mechanical Testing: Comprehensive mechanical tests were performed on the PEEK rods and modified titanium alloy screws to characterize their material properties and performance under relevant physiological loads. The specific tests and their outcomes (e.g., fatigue strength, static strength, bending stiffness) are not detailed in this summary but were provided to the FDA.
- Risk Analysis: A risk analysis was conducted to assess any new or different safety and effectiveness questions raised by the modifications.
- Comparison to Predicate Devices: The results of the mechanical tests and risk analysis were compared against established data for several predicate CD HORIZON® components (K043488, K041862, K042962, K000094, K042025, K032033, K043151, K021791) and the DYNESYS Spinal System (K031511). The comparison aimed to show that the new components perform at least as well as the predicates in terms of safety and effectiveness for identical indications.
Conclusion: The documentation provided, including mechanical test reports and risk analysis, demonstrated that the subject rods and screws are substantially equivalent to the identified predicate devices. The FDA concurred with this assessment, leading to the 510(k) clearance.

Summary

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CD HORIZON® Spinal System Summary of Safety and Effectiveness K050809 - June 2005

JUN 1 4 2005

I. Company: Medtronic Sofamor Danek, Inc. USA 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Contact: Richard W. Treharne, PhD Senior Vice President Regulatory Affairs
II. Proposed Proprietary Trade Name: CD HORIZON® Spinal System
III. Classification Name(s)/Product Code(s): Spinal Interlaminal Fixation and Spinal Intervertebral Fixation Orthosis and/or Pedicle Screw Spinal System (per 21 CFR Section 888.3050, 888.3060 and/or 888.3070) Product Codes: MNI, MNH, KWP, KWQ, NQPand NKB

IV. Product Description

The purpose of this 510(k) submission is to add PEEK rods as well as modified titanium alloy screws to the CD HORIZON® Spinal System.

page 1 of 3

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V. Indications

When used in a percutaneous, non-cervical, posterior approach with the SEXTANT instrumentation, the CD HORIZON® screws are intended 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 and/or lordosis); tumor: pseudoarthrosis; and/or failed previous fusion.

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VI. Substantial Equivalence

Documentation, including a mechanical test reports and a risk analysis, was provided which demonstrated the subject rods and screws to be substantially equivalent to predicate CD HORIZON® components previously cleared in K043488, K041862, K042962, K000094, K042025, K032033, K043151 and K021791. Additionally documentation, including mechanical test reports, were provided to demonstrate that the subject rods are substantially equirivalent to the previ rously cleared DYNESYS Spinal System (K031511, SE 03/05/04) for identical indications.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 4 2005

Mr. Richard Treharne, Ph.D. Senior Vice President Regulatory Affairs Medtronic Sofamor Danek, Inc. 1800 Pyramid Place Memphis. Tennessee 38132

Re: K050809

Trade/Device Name: CD Horizon® Spinal System Regulation Number: 21 CFR 888.3050, 888.3060, 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: III Product Code: KWQ, KWP, MNH, MNI, NKB Dated: May 17, 2005 Received: May 18, 2005

Dear Dr. Treharne:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Richard W. Treharne, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

ht. Clurda
Miriam Provost, Ph.D.

riam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

CD HORIZON® Spinal System Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Except for hooks, when used as an anterolateral thoracic/lumbar system, CD HORIZON® components such as ECLIPSE® components are intended for the following indications: {}} degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pscudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

In addition, when used as a pedicle screw fixation system, the CD HORIZON® LEGACY 3.5mm rod and associated components, are indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (LS-SI) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

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ហែប៉ុន្មែរ និង

and chronic instabilities of the thoracic, lumbar and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) kyphosis, and/or (3) failed previous fusion. Additionally, when used as a pedicle screw device, the CD HORIZON® Spinal System PEEK rod constructs are indicated for use in patients who: ( ) are receiving fusion with autogenous graft only, (2) who are having the device attached to the lumbar or sacral spinc, and/or (3) who are having the device removed after the development of a solid fusion mass.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stypt Clurda

Restorative. Division of Gene and Neurological Devices

510(k) Number K050809

pag. 2 of 2

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.