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.

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.

Certain implant components from other Medtronic spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washer, 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 3.5mm, 4.5mm rods or 6.35mm rods, while other components can connect to both 5.5mm rods and 6.35mm 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 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. No warranties express, or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MDT Catalog for further information about warranties and limitations of liability.

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.

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.

To achieve best results, do not use any of the CD HORIZON® Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all orthopaedic and neurosurgical implants, none of the CD HORIZON® Spinal System components should ever be reused under any circumstances.

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

AI/ML Overview

The provided text describes a 510(k) summary for the CD HORIZON® Spinal System but does not contain information about acceptance criteria or a study proving that a device meets such criteria.

The document is a regulatory submission to the FDA for a medical device (spinal system) and focuses on demonstrating substantial equivalence to previously cleared devices. It outlines:

Device Description: The components of the CD HORIZON® Spinal System and compatible parts from other Medtronic systems, materials used, and specific usage instructions (e.g., never mix stainless steel and titanium).
Indications for Use: The specific medical conditions for which the spinal system is intended, such as degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, and failed previous fusion.
Substantial Equivalence: The primary purpose of the submission, stating that the modified titanium alloy screws within the CD HORIZON® Spinal System are substantially equivalent in design, material, and indications for use to predicate devices previously cleared by the FDA (K032033, K041030, K050809, and K063670). It briefly mentions that safety and effectiveness are supported by documentation within the premarket notification, but no details of such documentation (like specific studies or acceptance criteria) are provided.
FDA Response: The FDA's letter confirming substantial equivalence and allowing the device to be marketed, along with general regulatory information.

Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information based on this document. These details are typically found in more comprehensive study reports or validation documentation, which are not part of this 510(k) summary.

Summary

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OCT 1 0 2008

CD HORIZON® Spinal System 510(k) Summary

September 2008

I. Company: Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738

Contact:

Brad Sheals Regulatory Affairs Specialist

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

III. Classification Name(s): Spinal Interlaminal Fixation and Spinal Intervertebral Fixation Orthosis and/or Pedicle Screw Spinal System (per 21CFR Section 888.3050. and/or 888.3070); Product Code(s): KWP, KWQ, MNH, MNI, NKB and NOP
IV. 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.

Certain implant components from other Medtronic spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washer, 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 $3.5mm, $4.5mm rods or $6.35mm rods, while other components can connect to both $5.5mm rods and $6.35mm rods. Care should be taken so that the correct components are used in the spinal construct.

Never use stainless steel and titanium implant components in the same construct.

Ncep 1 of 3

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K082236

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.

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

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.

page 2 of 3

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5082236

VI. Substantial Equivalence: The design features, material and indications for use of the CD HORIZON® Spinal System are substantially equivalent to the predicate CD HORIZON® components previously cleared in K032033 (S.E. 09/12/2003), K041030 (S.E. 06/30/2004), K050809 (S.E. 06/14/2005) and K063670 (S.E. 06/28/2007). The safety and effectiveness of the modified subject screws is adequately supported by documentation within this premarket notification.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure, with three curved lines forming the body and head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2008

Medtronic Sofamor Danek % Mr. Brad Sheals Regulatory Affair Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K082236

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, NQP, KWP, KWQ, MNH, MNI Dated: September 9, 2008 Received: September 11, 2008

Dear Mr. Sheals:

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 devive con be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA max 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 - Mr. Brad Sheals

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 Iogally marketed predicate device results in a classification for your device and thus, perroits 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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Milkeran

Mark N. Melkerson 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):

5082236

CD HORIZON® Spinal System Device Name:

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)

Mark A. Millman

Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K082236

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Regulation Number and Section

N/A