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: (1) 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, 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.e., fracture or dislocation); 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.

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® System can be connected to the VERTEX™ Reconstruction 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; GDLH® 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 include additional screws to the CD HORIZON® Spinal System.

AI/ML Overview

This document is a 510(k) premarket notification for the CD HORIZON® Spinal System. It asserts substantial equivalence to previously cleared devices. The document does not describe a study involving a device meeting acceptance criteria in the manner typically associated with AI/medical imaging device submissions (e.g., performance metrics, clinical trials).

Instead, it's a submission for a spinal implant system with the purpose of including "additional screws." The "acceptance criteria" here refer to regulatory acceptance for market clearance based on substantial equivalence, rather than performance criteria from a clinical trial or algorithm validation.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission.

Here's an interpretation based on the information provided, tailored to the type of device and submission:

1. Table of "Acceptance Criteria" (Regulatory) and Reported Device "Performance" (Substantial Equivalence Claim)

Criteria Category	Specific Criteria / Claim	Reported "Performance" / Evidence
Regulatory Acceptance	Substantial Equivalence to predicate devices.	Documents demonstrated substantial equivalence to similar CD HORIZON® Spinal System components previously cleared in K042025 (SE 8/25/04) and K000094 (SE 02/08/00).
Intended Use/Indications	Device is for posterior, non-cervical fixation for specific spinal conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, failed previous fusion).	The current submission adds screws to the existing system, which maintains the previously cleared indications for use. Specific indications for anterior use and supplementary fixation via the SPIRE Plate are also reiterated.
Device Design/Components	Integrates with existing CD HORIZON® System components and other Medtronic Sofamor Danek spinal systems (TSRH®, GDLH®, LIBERTY®, DYNALOK PLUS®).	The new screws are intended to be part of the CD HORIZON® Spinal System, implying compatibility and integration with established components.

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

Not Applicable. This submission is for additional components (screws) to an existing spinal system, asserting substantial equivalence based on prior clearances, not a performance study that would involve a test set of data.

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

Not Applicable. See point 2.

4. Adjudication method for the test set

Not Applicable. See point 2.

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 submission for a mechanical spinal implant system, not a diagnostic AI device.

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

Not Applicable. This is a submission for a mechanical spinal implant system, with no algorithm or standalone performance testing mentioned or relevant.

7. The type of ground truth used

Not Applicable. The "ground truth" in this context is regulatory acceptance and the established safety and effectiveness of the predicate devices for their indicated uses, which the current device is asserted to be substantially equivalent to. This is based on mechanical testing and clinical experience with the predicate devices, not on data "ground truth" as one would evaluate an AI model.

8. The sample size for the training set

Not Applicable. This is not an AI device or a study involving a training set of data.

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

Not Applicable. See point 8.

Summary

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K04315/

FEB - 1 2005

CD HORIZON® Spinal System Summary of Safety and Effectiveness November 2004

Medtronic Sofamor Danek, Inc. USA Company: I. 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133

Richard W. Treharne, PhD Contact: Senior Vice President Regulatory Affairs

Proposed Proprietary Trade Name: CD HORIZON® Spinal System II.
Classification Name(s)/Product Code(s): Spinal Interlaminal Fixation and Spinal III. Classification Nixation 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 and NKB

IV. Product Description

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 ooning and System can be connected to the VERTEX™ Reconstruction System through a rod connector.

The purpose of this 510(k) submission is to include additional screws to the CD HORIZON® Spinal System.

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v. Indications

V. So Indications
The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation for the I he CD HORLZON® Spinal bystein is misease (defined as back pain of discogenic origin with following indications. Gegenerative and radiographic studies); spondylolisthesis; trauma
degeneration of the disc confirmed by history and radiographic studies); spondy degeneration of the disc connamed by mesery will and the exphosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used in a percutaneous, non-cervical, posterior approach with the SEXTANT witch used in a perculancedes, non on screws are intended for the following indications: instrumentation, the CD HOREZONS back pain of discogenic origin with degeneration of the disc degenciative disease (defined as estadies); spondylolisthesis; trauma (i.e., fracture or commed by instory and radiograppers (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® Except for nooks, when abed as an anvonents are intended for the following indications: (1) components such as LCDI SEC vomponents and of discogenic origin with degeneration of the disc degenerative uiscase (as defined of onlines), (2) spinal stenosis, (3) spondylolisthesis, (4) commities (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 101 use in the non oct not of the results (1) supplemental fusion in the following conditions: degenerative process for the parpose of acknowing discogenic origin with degeneration of the disc confirmed by history and radiographic studies; spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be in order to active additional lovels of manol, ate a with the VERTEX™ rod connector. Refer to comfeetcu to the VERTEX - Recombination a Jersen Package Insert for a list of the VERTEXTM indications of use.

Substantial Equivalence VI.

VI. . . . Substantiall Equivatelice and demonstrated that the subject Documents were substantially equivalent to similar CD HORIZON® Spinal System components previously cleared in K042025 (SE 8/25/04) and in K000094 (SE 02/08/00).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 1 2005

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

Re: K043151

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: January 6, 2005 Received: January 7, 2005

Dear Dr. Treharne:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becaused in in in in in in in substantially equivalent (for the indications forcrenced above and harrsure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of to the enactment date of the Medical Device Amendments, or to conniner of prices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de neces mat have been require approval of a premarket approval application (PMA). and coometre for ( roy i roy have the device, subject to the general controls provisions of the Act. The r ou may, dierere, mains 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 If your device is classince (tools. Existing major regulations affecting your device can may of subject to back are al 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 r teast of action and itermination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I edetar statuates and states and the bet not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Orth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by overse (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) I mo loter witi are will and of substantial equivalence of your device of your device to a legally prematics notification. The active 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 in you atence of Compliance at (240) 276-0120. Also, please note the regulation entitled, Connact the Ories of Centre to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,
Mark A. Millman

Celia M. Witten,Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1 November 2004

510(k) Number (if known):	K043151
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CD HORIZON® Spinal System Device Name: ____________

Indications for Use:

Prescription Use(Part 21 CFR 801 Subpart D)	X	AND/OR	Over-The-Counter Use(21 CFR 807 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE/CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off)

Concurrence Division, Office of Device, Evalstorative)

and Neurological Devices

000220

510 (k) Number

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.