MODIFICATION TO: CD HORIZON SPINAL SYSTEM

K043151 · Medtronic Sofamor Danek · KWQ · Feb 1, 2005 · Orthopedic

Device Facts

• Record ID: K043151
• Device Name: MODIFICATION TO: CD HORIZON SPINAL SYSTEM
• Applicant: Medtronic Sofamor Danek
• Product Code: KWQ · Orthopedic
• Decision Date: Feb 1, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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 Story

System comprises rods, hooks, screws, plates, staples, and connectors for spinal construct assembly; used for immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as adjunct to fusion. Components are tailor-made for individual cases; can be rigidly locked in various configurations. Used in clinical settings by surgeons; instrumentation facilitates implantation. System supports percutaneous, posterior, and anterolateral approaches. Provides structural support to spine; facilitates fusion; helps correct deformities; stabilizes segments post-trauma or tumor resection. Benefits include improved spinal alignment and stability.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System includes rods, hooks, screws, plates, staples, and connectors. Components are modular and designed for rigid locking in various configurations. Compatible with VERTEX™ Reconstruction System via rod connectors. Materials and specifications are consistent with previously cleared CD HORIZON® components.

Indications for Use

Indicated for non-cervical spinal stabilization/immobilization as an adjunct to fusion in patients with degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis, or failed previous fusion. Used via posterior or anterolateral approaches.

Regulatory Classification

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.

Predicate Devices

• CD HORIZON® Spinal System (K042025)
• CD HORIZON® Spinal System (K000094)

Reference Devices

• VERTEX™ Reconstruction System

Submission Summary (Full Text)

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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 [phone]
### 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 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 ooning and 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.

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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 [phone]. 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 [phone] or [phone] 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 |
|---------------------------|---------|
|---------------------------|---------|

CD HORIZON® Spinal System Device Name: ____________

## 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 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.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(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