TRAVERSE OCT SPINAL FIXATION SYSTEM

K062447 · Medtronic Sofamor Danek, Inc. · KWP · Oct 15, 2007 · Orthopedic

Device Facts

• Record ID: K062447
• Device Name: TRAVERSE OCT SPINAL FIXATION SYSTEM
• Applicant: Medtronic Sofamor Danek, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Oct 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the TRAVERSE™ Spinal Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. Hooks and Rods The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. Screws/Connectors The use of screws is limited to placement in T1-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine. Titanium ATLAS® Cable used with the TRAVERSE™ Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.

Device Story

Posterior spinal fixation system; provides immobilization and stabilization as adjunct to fusion of cervical and upper thoracic spine (C1-T3). Components include rods, hooks, screws, and connecting components; tailor-made constructs for individual cases. Titanium ATLAS® cable may be used for attachment. Used by surgeons in clinical/OR settings. Output is a rigid construct providing mechanical stabilization to promote bone fusion. Benefits include stabilization of spinal segments in patients with degenerative or traumatic conditions.

Clinical Evidence

Bench testing only. Testing included compression fatigue, static compression, and static torsion to demonstrate mechanical equivalence to the predicate GALAXY™ 3.2 Spinal System.

Technological Characteristics

Constructed from medical grade titanium, titanium alloy, and cobalt-chromium-molybdenum alloy. Offset connectors include silicone adhesive elastomeric stakes. System is a posterior spinal fixation orthosis. No energy source or software components.

Indications for Use

Indicated for patients requiring cervical and thoracic (C1-T3) spinal fusion due to DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, or tumors. Screws restricted to T1-T3; not for cervical spine use.

Regulatory Classification

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.

Predicate Devices

• GALAXY™ 3.2 Spinal System (K043020)

Submission Summary (Full Text)

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Page 1 of 2

# TRAVERSE™ Spinal Fixation System 510(k) Summary - K062447

CCT 1 5 2007

September 2007

| I. | Company: | Medtronic Sofamor Danek USA |
|----|----------|-----------------------------|
| | | 1800 Pyramid Place |
| | | Memphis, Tennessee 38132 |
| | | Telephone: [phone] |
| | | Fax: [phone] |
| | Contact: | Raphael McInnis |

Regulatory Affairs Specialist

### II. Proposed Proprietary Trade Name: TRAVERSE™ Spinal Fixation System

- Classification Name(s): Spinal Interlaminal Fixation Orthosis; Spinal Intervertebral Body III. Fixation Orthosis; Pedicle Screw Spinal System; Orthosis, Spinal Pedicle Fixation, for Degenerative Disc Disease; Class: II; Product Code(s): KWP,MNI; and Regulation No .: 888.3050 and 888.3070
- IV. Legally Marketed Devices: GALAXY™ 3.2 Spinal System (K043020)
- V. Description: The TRAVERSE™ Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the cervical and/or upper thoracic spine.

The TRAVERSE™ Spinal Fixation System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, screws and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion. See the package inserts of both systems for labeling limitations.

The TRAVERSE™ Spinal Fixation System is fabricated from medical grade titanium, medical grade titanium alloy, and medical grade cobalt-chromium-molybdenum alloy. Medical grade titanium, medical grade titanium alloy and/or medical grade cobalt-chromium-molybdenum allov may be used together. Never use titanium alloy and/or cobalt-chromium-molybdenum alloy with stainless steel in the same construct. Lastly, the offset connectors contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel.

- VI. Indications for Use: When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the TRAVERSE™ Spinal Fixation System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

### Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

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### Screws/Connectors

The use of screws is limited to placement in T1-T3 only. The screws are not intended to be placed in the cervical spine.

Titanium ATLAS® Cable used with the TRAVERSE™ Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.

- VII. Substantial Equivalence: The TRAVERSE™ Spinal Fixation System is substantially equivalent to the GALAXY™ 3.2 Spinal System (K043020, SE 01/07/05). Performance bench testing performed for the TRAVERSE™ Spinal Fixation System includes compression fatigue, static compression, and static torsion. The purpose of this testing was to support substantial equivalence to the aforementioned GALAXY™ 3.2 Spinal System. The results of the testing performed on the TRAVERSE™ Spinal Fixation System were equivalent or better than the commercially available GALAXY™ 3.2 Spinal System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 2007

Medtronic, Inc. c/o Mr. Raphael McInnis Regulatory Affairs Specialist 1800 Pyramid Place Memphis, TN 38132

Re: K062447

Trade/Device Name: TRAVERSE™ Spinal Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, MNI Dated: September 28, 2007 Received: October 1, 2007

Dear Mr. McInnis:

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.

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. Raphael McInnis

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Jarlau BuchnD
MLN. M. W.

Mark N. Melke Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### CONFIDENTIAL

### 510(k) Number (if known): K062447

Device Name: TRAVERSE™ Spinal Fixation System

### Indications for Use

When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the TRAVERSETM Spinal Fixation System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

### Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

### Screws/Connectors

The use of screws is limited to placement in T1-T3 in treating thoracic conditions only.

Screws are not intended to be placed in the cervical spine.

Titanium ATLAS™ Cable used with the TRAVERSE™ Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.

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

Aubare Buchan Johnson

and Neurological Devices

510(k) Number_K062447