GATEWAY THORACOLUMBAR PLATE SYSTEM

K062407 · Globus Medical, Inc. · KWQ · Sep 6, 2006 · Orthopedic

Device Facts

• Record ID: K062407
• Device Name: GATEWAY THORACOLUMBAR PLATE SYSTEM
• Applicant: Globus Medical, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Sep 6, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

GATEWAY™ Thoracolumbar Plate System is a spinal fixation device used by surgeons in clinical settings. System consists of plates of various lengths, polyaxial or monoaxial REVERE™ screws, and variable or fixed bone screws. Polyaxial/monoaxial screws attach to plate rod portion; locking caps secure connection. Optional staples provide additional fixation to vertebral bodies. Device provides stabilization for T1-L5 spine instability. Surgeon implants device to fixate vertebral bodies, addressing conditions like fractures, tumors, or degenerative disc disease. Benefits include spinal stabilization and correction of deformities.

Clinical Evidence

Bench testing only. Mechanical testing performed in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s' (May 3, 2004).

Technological Characteristics

Implants composed of titanium alloy per ASTM F136 and F1295. System includes plates, polyaxial/monoaxial screws, and locking caps. Mechanical fixation device; no energy source or software components.

Indications for Use

Indicated for patients with thoracolumbar (T1-L5) spine instability caused by fracture, tumor, degenerative disc disease, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.

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

• Globus REVERE™ Stabilization System (K061202)
• DePuy Profile Anterior Thoracolumbar Plate (K973060)

Submission Summary (Full Text)

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K062407
510(k) - GATEWAY™ System

#### 510(k) Summary

# SUBMITTED BY:

Globus Medical Inc. 303 Schell Lane Phoenixville, PA 19460 [phone] 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:

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.

## INTENDED USE:

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.

## 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 [phone] or [phone] 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:

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.

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)

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buettner

Division of General, Restorative, and Neurological Devices

510(k) Number K062407