TRUSS THORACOLUMBAR PLATE SYSTEM

K092108 · Globus Medical, Inc. · KWQ · Aug 13, 2009 · Orthopedic

Device Facts

• Record ID: K092108
• Device Name: TRUSS THORACOLUMBAR PLATE SYSTEM
• Applicant: Globus Medical, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Aug 13, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TRUSS™ 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

TRUSS™ Thoracolumbar Plate System consists of rigid and compression plates of varying lengths used with variable or fixed angle bone screws; implants attach to anterolateral or lateral vertebral bodies (T1-L5). Device provides spinal stabilization for patients with instability from fracture, tumor, degenerative disc disease, scoliosis, kyphosis, lordosis, spinal stenosis, or failed surgery. Used by surgeons in clinical settings to restore spinal alignment and stability; benefits patient by providing mechanical support to the vertebral column.

Clinical Evidence

Bench testing only; no clinical data presented.

Technological Characteristics

Titanium alloy implants (ASTM F136, F1295, F1472). System includes rigid and compression plates with variable or fixed angle bone screws. Designed for anterolateral or lateral thoracolumbar fixation.

Indications for Use

Indicated for patients requiring stabilization of the thoracolumbar spine (T1-L5) due to instability from fracture, tumor, degenerative disc disease, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous 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

• GATEWAY® Thoracolumbar Plate System (K062407)
• REVERE® Stabilization System (K061202)

Submission Summary (Full Text)

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# 510(k) Summary: TRUSS™ Thoracolumbar Plate System

| Company: | Globus Medical Inc.<br>2560 General Armistead Ave.<br>Audubon, PA 19403<br>[phone] | AUG 18 2009 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Kelly J. Baker, Ph.D<br>Director, Clinical Affairs & Regulatory | |
| Device Name: | TRUSS™ Thoracolumbar Plate System | |
| Classification: | Per 21 CFR as follows:<br>§888.3060 Spinal Intervertebral Body Fixation Orthosis<br>Product Codes KWQ.<br>Regulatory Class II. Panel code 87. | |
| Predicate Device: | GATEWAY® Thoracolumbar Plate System K062407<br>SE Date September 6, 2006<br>REVERE® Stabilization System K061202<br>SE Date July 20, 2006 | |

### Device Description:

The TRUSS™ Thoracolumbar Plate System consists of rigid and compression plates of various lengths that are used with variable or fixed angle bone screws. These plates attach to the anterolateral or lateral portion of the vertebral bodies of the thoracolumbar spine (T1-L5). Implants are composed of titanium allov, as specified in ASTM F136. F1295 and F1472.

#### Intended Use:

The TRUSS™ 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, spinal stenosis, or failed previous spine surgery.

#### Basis of Substantial Equivalence:

The TRUSS™ Thoracolumbar Plate System implants are similar to the predicate Globus GATEWAY® Thoracolumbar Plate System K062407 and REVERE® Stabilization System K061202 with respect to technical characteristics, performance, and intended use. Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3. 2004 is presented

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a bird or eagle in flight, composed of three curved lines. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Globus Medical Inc. % Kelly J. Baker, Ph.D Director, Clinical Affairs & Regulatory 2560 General Annistead Avenue Audubon, Pennsylvania 19403

AUG 1 3 2009

Re: K092108

Trade/Device Name: TRUSS™ Thoracolumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: July 9, 2009 Received: July 14, 2009

Dear Dr. Baker:

We have reviewed your Scction 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 J. Baker, Ph.D

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Oabar Bnechud

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

510(k) Number:

K092108

TRUSS™ Thoracolumbar Plate System Device Name:

Indications:

The TRUSS™ 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.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Eo Z (TEXT for MEM)
(DLH-MEM)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K092108 510(k) Number_