ASSURE ANTERIOR CERVICAL PLATE SYSTEM

K040721 · Globus Medical, Inc. · KWQ · Jun 17, 2004 · Orthopedic

Device Facts

• Record ID: K040721
• Device Name: ASSURE ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Globus Medical, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Jun 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ASSURE™ 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

ASSURE™ Anterior Cervical Plate System is a spinal fixation orthosis; consists of titanium alloy plates, standard or rigid screws, and set screws. Used for anterior fixation of cervical spine (C2-C7). Implanted by surgeons in clinical settings to stabilize vertebral bodies. Provides mechanical support to facilitate fusion in patients with degenerative, traumatic, or structural spinal conditions. Benefits include spinal stabilization and correction of deformities.

Clinical Evidence

Bench testing only. Static and dynamic mechanical testing performed in accordance with ASTM F1717 to demonstrate substantial equivalence.

Technological Characteristics

Titanium alloy implants; includes plates, standard/rigid screws, and set screws. Designed for anterior cervical spine fixation (C2-C7). Mechanical performance validated per ASTM F1717.

Indications for Use

Indicated for anterior screw fixation to the cervical spine (C2-C7) in patients with 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

• Synthes CSLP (K926453, K030866)
• Depuy PEAK (K971730)
• Howmedica Osteonics (Stryker) Reflex (K031702)

Submission Summary (Full Text)

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#### 510(K) Summary III.

0407d/
page 1 of 2

#### SUBMITTED BY:

Globus Medical Inc. 303 Schell Lane Phoenixville, PA 19460 [phone] x218 Contact: Kelly J. Baker Prepared: March 18, 2004

#### DEVICE NAME:

ASSURE™ Anterior Cervical Plate System

## CLASSIFICATION:

The device classification is Class II as per 21 CFR §888.3060 Spinal Intervertebral Body Fixation Orthosis. The product code is KWQ. The panel code is 87.

## PREDICATE DEVICES:

Synthes CSLP: K926453, SE date October 12, 1993; K030866, April 18, 2003. Depuy PEAK: K971730, SE date November 3, 1997. Howmedica Osteonics (Stryker) Reflex: K031702, SE date August 8, 2003. The product code for these devices is KWQ.

## DEVICE DESCRIPTION:

The ASSURE™ Anterior Cervical Plate System consists of plates used with either standard screws or rigid screws and set 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.

## INTENDED USE:

The ASSURE™ 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.

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yoZal

510(k) Premarket Notification - ASSURE™System

#### PERFORMANCE DATA:

Static and dynamic mechanical testing, in accordance with ASTM F1717, was State and dynamic moonamed. As a basis for substantial equivalence.

# BASIS OF SUBSTANTIAL EQUIVALENCE:

The ASSURE™ Anterior Cervical Plate System implants are similar to the predicate Synthes CSLP (K926453, K030866), Depuy PEAK (K971730), Howmedica Osteonics (Stryker) Reflex (K031702), anterior cervical plate systems with respect to technical characteristics and performance.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of three stylized human figures in profile, representing health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 7 2004

Globus Medical Inc. . c/o Kelly J. Baker, Ph.D. 303 Schell Lanc Phoenixville, PA 19460

Re: K040721

Trade/Device Name: ASSURE™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 18, 2004 Received: March 19, 2004

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 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action S product radiation control provisions (Sections 557 - 32 described in your Section 510(k)
This letter will allow you to begin marketing your device of your davice to a legal This letter will anow you to begin makemig your antial equivalence of your device to a legally premarket notification. The FDA iniding of substanted by July 2017 11:50
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
r the regulation and consisted on the collected on the regulation ontitled If you desire specific advice for your de not of the mote the regulation entitled. contact the Office of Complanes at (301) 27 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - Division of Small " Misbranding by reference to premarket nouthead on the Act from the Division of Small other general information on your responsible and its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-frememain html Manufacturers, International and Consumer Passion. As a gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

R. Mark A. Millerson

Celia M. Witten, Ph.D., M.D. 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) Premarket Notification - ASSURE™System

| II. | Indications for Use Statement |
|-----|-------------------------------|
|-----|-------------------------------|

| 510(k) Number: | K040721 |
|----------------|----------------------------------------|
| Device Name: | ASSURE™ Anterior Cervical Plate System |

#### Indications:

The ASSURE™ Anterior Cervical Plate System is intended for anterior screw The ASSURL - Antenor Oct Noar Flato System Andications: degenerative likation to the cervical Spine SE Onlin of discogenic origin with degeneration of disc disease (as delined by nook pain of accographic studies), trauma the uise connimed by pations history ity (defined as kyphosis, lordosis, or (Including fractures), turnors, dolormity (dolined aspondylolisthesis, and spinal stenosis.

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

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Wilkerson

Division of General, Restorative, and Neurological Devices

510(k) Number K04072