The GATEWAY™ Thoracolumbar Plate System is intended for use in the treatment of thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.

Device Description

The GATEWAY™ Thoracolumbar Plate System consists of plates of various lengths to be used with polyaxial or monoaxial REVERE™ screws and variable or fixed bone screws. Polyaxial or monoaxial REVERE™ screws attach to the rod portion of the plate and variable or fixed bone screws are inserted through the plate, for fixation of GATEWAY plates to the vertebral bodies of the thoracolumbar spine (T1-L5). REVERE™ locking caps are used to connect polyaxial or monoaxial screws to the rod portion of the plate. Optional staples may be used for additional fixation of polyaxial or monoaxial screws to vertebral bodies. Implants are composed of titanium alloy, as specified in ASTM F136. F1295.

AI/ML Overview

This 510(k) summary for the GATEWAY™ Thoracolumbar Plate System describes a medical device, not an AI or software device. Therefore, many of the requested categories for AI/software performance evaluation are not applicable.

Here's an analysis based on the provided text, focusing on what is available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s", May 3, 2004	"Mechanical testing... is presented." (The specific results meeting the criteria are not detailed in this summary but are stated to have been presented.)
Substantial equivalence to predicate devices (Globus REVERE™ Stabilization System K061202 and DePuy Profile Anterior Thoracolumbar Plate K973060) in technical characteristics, performance, and intended use.	The FDA reviewed the 510(k) and "determined the device is substantially equivalent... to legally marketed predicate devices."

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

Not applicable. This is a hardware device. Performance is evaluated through mechanical testing, not a clinical test set with patient data.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not expert clinician consensus.

4. Adjudication Method for the Test Set

Not applicable.

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

No. This is a hardware device.

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

Not applicable. This is a hardware device.

7. The Type of Ground Truth Used

For mechanical testing, the "ground truth" would be the engineering specifications and performance standards outlined in ASTM F136 and F1295, as well as the FDA's "Guidance for Spinal Systems 510(k)s."

8. The Sample Size for the Training Set

Not applicable. This is a hardware device. Design and manufacturing involve engineering principles and testing, not a "training set" in the machine learning sense.

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

Not applicable. Testing and design are based on established engineering principles and FDA guidance, not a machine learning training set with "ground truth" established by experts.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is primarily mechanical testing. The 510(k) summary explicitly states: "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s', May 3, 2004 is presented."

The ultimate "proof" of meeting acceptance criteria for substantial equivalence also comes from the FDA's review and determination. The FDA's letter (K062407) states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This determination is based on the data provided, including the mechanical testing results, and comparison to the predicate devices.

The acceptance criteria are met when the mechanical test results demonstrate performance comparable to the predicate devices and in compliance with relevant FDA guidance, and when the FDA officially agrees that the device is substantially equivalent based on its technical characteristics, performance, and intended use.

Summary

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K062407
510(k) - GATEWAY™ System

510(k) Summary

SUBMITTED BY:

Globus Medical Inc. 303 Schell Lane Phoenixville, PA 19460 (610) 415-9000 x218 Contact: Kelly J. Baker

SEP - 6 2006

DEVICE NAME:

GATEWAY™ Thoracolumbar Plate System

CLASSIFICATION:

21 CFR §888.3060 Spinal Intervertebral Body Fixation Orthosis Product Codes KWQ. Regulatory Class II. Panel code 87.

PREDICATE DEVICES:

Globus REVERE™ Stabilization System K061202 (SE date July 20, 2006) DePuy Profile Anterior Thoracolumbar Plate K973060 (SE date Nov 3. 1997), Product codes KWQ. Regulatory Class II.

DEVICE DESCRIPTION:

INTENDED USE:

PERFORMANCE DATA:

Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s", May 3, 2004 is presented.

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BASIS OF SUBSTANTIAL EQUIVALENCE:

The GATEWAY™ Thoracolumbar Plate System implants are similar to the predicate Globus REVERE™ Stabilization System (K061202) and DePuy Profile Anterior Thoracolumbar Plate System (K973060), with respect to technical characteristics, performance, and intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 6 2006

Globus Medical % Kelly Baker, PhD Director, Regulatory and Clinical Affairs Valley Forge Business Center 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K062407

Trade/Device Name: GATEWAY™ Thoracolumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 16, 2006 Received: August 17, 2006

Dear Dr. Baker:

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 adultcration.

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 - Kelly Baker, PhD

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 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely, yours,

Barbara Buckland
for

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) - GATEWAY™ System

Indications for Use Statement ll.

4062407 510(k) Number:

GATEWAY™ Thoracolumbar Plate System Device Name:

Indications:

Prescription Use __ X (Per 21 CFR §801.109) Over-The-Counter Use

(PLEASE DO NOT WRITE ON THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buettner

Division of General, Restorative, and Neurological Devices

510(k) Number K062407

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

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