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.

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, (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® 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 (L3 and below); and (d) 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™ 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 add previously cleared EQUATION™ Fixation System 3.5mm rods and associated components to the CD HORIZON® Spinal System, and to simply change the name of the components from EQUATION™ Fixation System components to CD HORIZON® Spinal System components.

AI/ML Overview

The provided text is a 510(k) summary for the CD HORIZON® Spinal System and does not contain information on acceptance criteria or a study proving the device meets said criteria. The document describes the product, its indications for use, and a statement of substantial equivalence to previously cleared devices. It is a regulatory submission for market clearance, not a performance study report.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Summary

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DEC 14 2004		CD HORIZON® Spinal SystemSummary of Safety and EffectivenessNovember 2004 – K042962
I.	Company:	Medtronic Sofamor Danek, Inc. USA1800 Pyramid PlaceMemphis, TN 38132(901) 396-3133
	Contact:	Richard W. Treharne, PhDSenior 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. 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 and NKB

Product Description IV.

V. Indications

Page 1 of 2

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(i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

Substantial Equivalence VI.

Documentation was provided which demonstrated the subject components to be substantially equivalent to the previously cleared EQUATION™ Fixation System device (K042453) for use for identical indications.

Page 2 of 2

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo, which is a stylized caduceus. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2004

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

Re: K042962

Trade/Device Name: CD HORIZON® Spinal System Trade:Dovros 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 Regaratory of : NKB, KWQ, KWP, MNH, MNH Dated: October 26, 2004

Dear Dr. Treharne:

Received: October 27, 2004

We have reviewed your Section 510(k) premarket notification of intent to market the device i We have reviewed your Section 3 ro(t) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for the stated in the Clerosule) to regarly manatinent date of the Medical Device Amendments, or to commerce prior to May 28, 1976, the exactiance with the provisions of the Federal Food. Drug. devices that have been recatismed in assess as a proval of a premarket approval application (PMA). and Cosment Act (Act) that do not require appro the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the free herefits of the more of the masanst 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 classified (500 above) ins. Existing major regulations affecting your device can may be subject to suell additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outsements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least of advised that I Dr o resuar.to syour device complies with other requirements of the Act that I Dr has made a determentlations administered by other Federal agencies. You must of any I catales and and and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 607), adomig (21 CFR Part 820); and if applicable, the electronic form in the quality bybeline (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Richard W. Treharne, PhD

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in yours finding of substantial equivalence of your device to a legally premailed predicated. 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 11 you a 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 other golders, 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,

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 October 2004

510(k) Number (if known):	K042962
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Device Name: _________________________________________________________________________________________________________________________________________________________________

CD HORIZON® Spinal System

Indications for Use:

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 thoneanous: degonomic vouse radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spiral stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

Prescription Use(Part 21 CFR 801 Subpart D)	X	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)

Division of General, Restorative,

Concurrence of CDRH, Office of Device Evaluation (ODE)

and Neurological Devices

510(k) Number	K042962
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Regulation Number and Section

N/A