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 degencration 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; pseudarthritis; and/or failed provious 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 CD HORIZON SPIRE™ Plate is a posterior, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (as previously defined); spondylolisthesis, trauma; and/or tumor.

In order to achieve additional levels of fixation as an adjunct to fusion, 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 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. The purpose of this submission is to meet our surgeon's needs by adding more connection options, filling in sizes that have not previously existed, and to add an open-connection feature for the rods.

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, 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.

AI/ML Overview

The provided text is a 510(k) summary for the CD HORIZON® Spinal System and primarily focuses on describing the device, its components, materials, and intended use. It also mentions substantial equivalence to predicate devices based on mechanical testing.

However, the document does not contain information about:

Specific acceptance criteria for device performance.
Any clinical study designed to prove the device meets specific acceptance criteria.
Details on sample size for test sets, data provenance, expert ground truth, adjudication methods, or MRMC comparative effectiveness studies.
Standalone algorithm performance, training set size, or how ground truth was established for a training set. (These topics usually relate to AI/ML device evaluations, which don't seem applicable to this spinal system submission).

The summary states: "The results of the mechanical testing performed for the subject CD HORIZON® Spinal System components were equivalent to the testing performed for the predicate CD HORIZON® Spinal System and TSRH® Spinal System components." This implies that the device's mechanical performance was deemed acceptable if it matched that of already approved predicate devices.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria, reported device performance, or details about the study that proves the device meets acceptance criteria, as this information is not present in the provided text. The document focuses on regulatory approval through substantial equivalence based on mechanical testing, rather than reporting on specific performance metrics against defined acceptance criteria from a clinical study.

Summary

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CD HORIZON® Spinal System 510(k) Summary

May 2009

Company:	Medtronic Sofamor Danek USA1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901) 396-3133Fax: (901) 346-9738	MAY 15 2005
Contact:	Melisa Lansky, M.B.A.

Sr. Regulatory Affairs Specialist

Proposed Proprietary Trade Name: CD HORIZON® Spinal System 11.

III. Classification Name(s):

Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Fixation Orthosis, and/or Pedicle Screw System Class: II, III Product Code(s): MNI, MNH, KWP, KWQ, and/or NKB Regulation No .: 888.3050, 888.3060, 888.3070

Description: 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. The purpose of this submission is to meet our surgeon's needs by adding more connection options, filling in sizes that have not previously existed, and to add an open-connection feature for the rods.

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V. Indications for Use: 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 and/or lordosis); tumor; pseudarthritis; 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.

In order to achieve additional levels of fixation as an adjunct to fusion, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod conncctor. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

Substantial Equivalence: Documentation was provided demonstrating that the CD VI. HORIZON® Spinal System is substantially equivalent to other commercially available fixation systems including CD HORIZON® Spinal System in K981676 (SE 1/28/99), K040962 (SE 5/14/04), K050981 (SE 5/18/05), and TSRH® Spinal System in K052144 (SE 9/2/05). The results of the mechanical testing performed for the subject CD HORIZON® Spinal System components were equivalent to the testing performed for the predicate CD HORIZON® Spinal System and TSRH® Spinal System components.

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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 text "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 several curved lines.

Public Health Service

MAY 15 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Sofamor Danek, USA % Ms. Melisa Lansky, M.B.A 1800 Pyramid Place Memphis, Tennessee 38132

Re: K090390

Trade/Device Name: CD Horizon® Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNI, MNH, KWQ, KWP Dated: April 15, 2009 Received: April 16, 2009

Dear Ms. Lansky:

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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- Ms. Melisa Lansky, M.B.A

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark A. Millman

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: __ CD HORIZON® Spinal System

Indications for Use:

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.

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)

Division Sign-Off)

or of Surgical, Orthopedic,
and Restorative Devices
J Restorative Devices

Regulation Number and Section

N/A