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 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.

AI/ML Overview

The TRAVERSE™ Spinal Fixation System is a medical device, and its acceptance criteria are established through performance bench testing to demonstrate substantial equivalence to a legally marketed predicate device.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from predicate)	Reported Device Performance (TRAVERSE™ Spinal Fixation System)
Compression fatigue performance	Equivalent or better than GALAXY™ 3.2 Spinal System (K043020)
Static compression performance	Equivalent or better than GALAXY™ 3.2 Spinal System (K043020)
Static torsion performance	Equivalent or better than GALAXY™ 3.2 Spinal System (K043020)

Study Proving Device Meets Acceptance Criteria:

The study that proves the TRAVERSE™ Spinal Fixation System meets its acceptance criteria is a performance bench testing study. This study was conducted to demonstrate "substantial equivalence" of the TRAVERSE™ system to the predicate device, the GALAXY™ 3.2 Spinal System (K043020).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact number of TRAVERSE™ components or configurations tested in the bench performance study. It generally refers to "the results of the testing performed on the TRAVERSE™ Spinal Fixation System."
Data Provenance: The data is from prospective bench testing conducted for the purpose of this 510(k) submission. The country of origin for the data generation would likely be the location of Medtronic Sofamor Danek USA's testing facilities, which is not explicitly stated but implied to be within the US (Memphis, Tennessee).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the evaluation was based on bench testing against engineering standards and comparison to a predicate device, not on clinical human interpretation of data where "ground truth" would be established by experts.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation was based on bench testing against engineering standards, not on human interpretation or classification that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a bench performance test for mechanical equivalence, not a clinical study involving human readers or patient outcomes, nor one assessing human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device (TRAVERSE™ Spinal Fixation System) is a physical spinal fixation system, not a software algorithm or AI-powered diagnostic tool. The performance evaluation was of its physical characteristics.

7. The Type of Ground Truth Used

The ground truth used for the acceptance criteria was engineering performance standards and the established performance characteristics of the predicate device (GALAXY™ 3.2 Spinal System). The "ground truth" for the new device was its measured mechanical performance in compression fatigue, static compression, and static torsion tests.

8. The Sample Size for the Training Set

This information is not applicable. The TRAVERSE™ Spinal Fixation System is a physical medical device, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" for this type of medical device evaluation.

Summary

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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: (901) 396-3133
		Fax: (901) 346-9738
	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.

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 (240) 276-0120. 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 (240) 276-3474. For questions regarding 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.

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:

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

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
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.(b)
Classification. Class II.