MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEM

K070775 · Globus Medical, Inc. · KWQ · Apr 19, 2007 · Orthopedic

Device Facts

• Record ID: K070775
• Device Name: MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Globus Medical, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Apr 19, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PROVIDENCE™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

Device Story

PROVIDENCE™ Anterior Cervical Plate System consists of titanium alloy plates and variable or fixed angle screws; used for anterior fixation of cervical spine (C2-C7). Device provides structural support to vertebral bodies; used by surgeons in clinical settings to stabilize spine following trauma, tumor resection, or degenerative conditions. System facilitates fusion by maintaining alignment; benefits patients by addressing spinal instability and associated pain. No software or electronic components.

Clinical Evidence

Bench testing only. Mechanical testing was conducted in accordance with the FDA guidance document 'Guidance for Industry and FDA Staff. Guidance for Spinal Systems 510(k)s' (May 3, 2004). No clinical data was provided.

Technological Characteristics

Materials: Titanium alloy (ASTM F136, F1295). Components: Plates and variable/fixed angle screws. Application: Anterior cervical spine fixation (C2-C7). Mechanical/structural device; no software, electronics, or energy sources.

Indications for Use

Indicated for patients requiring anterior screw fixation to the cervical spine (C2-C7) for degenerative disc disease, trauma (fractures), tumors, deformity (kyphosis, lordosis, scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, or spinal stenosis.

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

• ASSURE® Anterior Cervical Plate System (K040721)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the text "510(k) - PROVIDENCE TM" on the bottom left and "K070775" on the top right. The text is in black and the background is white. The text "510(k) - PROVIDENCE TM" is underlined.

#### 510(k) Summary =

APR 1 9 2007

DEVICE NAME: PROVIDENCE™ Anterior Cervical Plate System

# SUBMITTED BY:

Globus Medical Inc. Valley Forge Business Center 2560 General Armistead Ave. Audubon, PA 19403 [phone] Contact: Kelly J. Baker, PhD

## CLASSIFICATION:

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

# PREDICATE DEVICE:

ASSURE® Anterior Cervical Plate System K040721 (SE June 17, 2004) Product code KWQ. Regulatory Class II.

# DEVICE DESCRIPTION:

The PROVIDENCE™ Anterior Cervical Plate System consists of plates used with either variable or fixed angle screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). The implants are composed of titanium alloy, as specified in ASTM F136, F1295.

### INTENDED USE:

The PROVIDENCE™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

### 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.

# BASIS OF SUBSTANTIAL EQUIVALENCE:

The PROVIDENCE™ Anterior Cervical Plate System implants are similar to the predicate ASSURE® devices with respect to technical characteristics, performance, and intended use.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Globus Medical, Inc. % Kelly J. Baker, Ph.D. Director, Regulatory and Clinical Affairs Valley Forge Business Center 2560 General Armistead Ave. Audubon, Pennsylvania 19403

APR 1 9 2007

K070775 Re:

> Trade/Device Name: Providence Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: March 16, 2007 Received: March 21, 2007

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 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

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# Page 2 - Kelly J. Baker, Ph.D.

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. 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 vours.

Sincerely yours,

Mark A Millhenn

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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#### Indications for Use Statement ll.

K070775 510(k) Number:

PROVIDENCE™ Anterior Cervical Plate System Device Name:

Indications:

The PROVIDENCE™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

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)

Mark A. Milkerson

18ton Sign-O Division of General, Restorative, and Neurological Devices

**510(k) Number** K070775