When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the CD HORIZON® Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal turnor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the CD HORIZON® Spinal System is 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: (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the CD HORIZON® Spinal System is 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.

When used in a percutaneous posterior approach with the SEXTANT instrumentation, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for the following indications:

When used as a pedicle screw fixation system the CD HORIZON® Cannulated M8 Multi-Axial Screw 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 (L3 and below); (d) who are having the device removed after the development of a solid fusion mass.

In addition, when used as a posterior spine thoracic/lumbar system, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for: (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. degenerative scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The CD HORIZON® ECLIPSE® components are intended for the following indications: When used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System is 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.

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.

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, stainless steel CD HORIZON® 4.5mm rods and associated components may be used posteriorly.

The purpose of this 510(k) submission is to expand the length range of the CD HORUZON® ECLIPSE Cannulated Screws and to add an 8.5mm diameter CD HORIZON® ECLIPSE screw to the system.

AI/ML Overview

This document is a 510(k) premarket notification for the CD HORIZON® Spinal System. It seeks to expand the length range of the CD HORIZON® ECLIPSE Cannulated Screws and add an 8.5mm diameter CD HORIZON® ECLIPSE screw to the system.

The document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical or diagnostic algorithm.

Instead, this document focuses on demonstrating substantial equivalence to a previously legally marketed predicate device (in this case, the CD HORIZON® Spinal System itself). The "study" mentioned here is a "Summary of Safety and Effectiveness" report which, in the context of a 510(k) for a spinal implant, primarily involves showing that the modifications or additions to the existing device have the same technological characteristics, indications for use, and safety and effectiveness profile as the predicate device.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for test/training sets, training set sample size, ground truth establishment for training set) are not applicable to this type of regulatory submission and the information provided.

Here is a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to predicate device for expanded screw lengths and diameters.	The CD HORIZON® Spinal System (with added components) was found to be "substantially equivalent" to itself (the predicate device) by the FDA. This implies that the device is considered safe and effective for its stated indications for use, similar to the existing device.

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

Not Applicable. This document does not describe a clinical performance study with a test set of data for a diagnostic or AI device. The submission is for a spinal implant and relies on demonstrating substantial equivalence to an existing device rather than presenting new performance data from a clinical trial in the way an AI/diagnostic device would. The "data provenance" would relate to engineering specifications, material properties, and potentially limited biomechanical testing, but not clinical patient data in the context of an "AI test set."

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 (e.g., 2+1, 3+1, none) 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 spinal implant, not an AI or diagnostic imaging device that would involve human readers.

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

Not Applicable. This is a spinal implant, not a standalone algorithm.

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

Not Applicable. For a medical device like a spinal implant under a 510(k) submission emphasizing substantial equivalence, the "ground truth" refers to established safety and effectiveness of the legally marketed predicate device, as well as adherence to recognized standards for materials, manufacturing, and design. There isn't a "ground truth" derived from patient diagnostic data in the same way there would be for an AI diagnostic tool.

8. The sample size for the training set:

Not Applicable. See point 2.

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

Not Applicable. See point 2.

In summary: The provided document is a 510(k) summary for a spinal implant. The "acceptance criteria" and "study" are primarily focused on demonstrating "substantial equivalence" to a predicate device, as opposed to presenting detailed performance metrics from a clinical study for a diagnostic or AI-driven device. Therefore, much of the requested information is not relevant or available within this type of regulatory submission.

Summary

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K021061
page 1 of 2

CD HORIZON® Spinal System Summary of Safety and Effectiveness April 2002

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

Proposed Proprietary Trade Name: CD HORIZON® Spinal System II.

Product Description III.

The purpose of this 510(k) submission is to expand the length range of the CD HORUZON® ECLIPSE Cannulated Screws and to add an 8.5mm diameter CD HORIZON® ECLIPSE screw to the system.

IV. Indications

The CD HORIZON® system is intended for the following indications:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the CD HORIZON® Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

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

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021061 page 2 of 2

When used in a percutaneous posterior approach with the SEXTANT instrumentation, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for the following indications:

When used as a pedicle screw fixation system the CD HORIZON® Cannulated M8 Multi-Axial Screw components are also 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 (L3 and below); (d) who are having the device removed after the development of a solid fusion mass.

The CD HORIZON® ECLIPSE components are intended for the following indications: When used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System is 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.

V. Substantial Equivalence

Documentation was provided which demonstrated the CD HORIZON® Spinal System to be substantially equivalent to itself.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal for the Department of Health & Human Services-USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the seal are three stylized profiles of human faces, stacked on top of each other.

9200 Corporate Boulevard Rockville MD 20850

Food and Drug Administration

JUL 2 5 2002

Mr. Richard W. Treharne, PhD Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis. Tennessee 38132

Re: K021061

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: Class II Product Code: KWP, KWQ, MNH, MNI Dated: July 8, 2002 Received: July 10, 2002

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.

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Page 2 – Mr. Richard W. Treharne, PhD

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours.

Mark A. Milliman

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

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Page 1 of 2 March 2002

510(k) Number (if known):	K021061
---------------------------	---------

CD HORIZON® Spinal System_____________________________________________________________________________________________________________________________________________________ Device Name: ______________

Indications for Use:

The CD HORIZON® system is intended for the following indications:

When used in a percutaneous posterior approach with the SEXTANT instrumentation, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for the following indications:

for
(Division Sign-Off)
Division of General, Restorative

and Neurological Devices

510(k) Number K021061

-00089

(Continued on the next page)

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

Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-counter Use _

14021061

(Optional 1-2-96)

Mark N Melhuse
for (Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number K021061

-000900

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.