NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM

K053581 · Nuvasive, Inc. · KWQ · Feb 17, 2006 · Orthopedic

Device Facts

• Record ID: K053581
• Device Name: NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Feb 17, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NuVasive SmartPlate Gradient Plus System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion. WARNING: The NuVasive SmartPlate Gradient Plus System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Device Story

System consists of plates, screws, and screw-retaining covers for anterior cervical spine stabilization; adjunct to cervical fusion. Used by surgeons in clinical settings. Provides mechanical fixation to stabilize spinal segments. Benefits patients by facilitating fusion in cases of degenerative disc disease, trauma, deformity, or tumor. No software or electronic components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Cervical plate and screw system; metallic implants. Mechanical fixation principle. No software, electronics, or connectivity.

Indications for Use

Indicated for anterior cervical spine fixation in patients requiring stabilization as an adjunct to cervical fusion. Conditions include degenerative disc disease (neck pain of discogenic origin confirmed by history/radiography), spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis, or failed previous fusion. Contraindicated for posterior element (pedicle) fixation in cervical, thoracic, or lumbar spine.

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

• SmartPlate Gradient CLP System

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf-like shape on the left, followed by the word "NUVASIVE" in bold, sans-serif font. Below the word "NUVASIVE" is the tagline "Creative Spine technology" in a smaller, italicized font. The logo is simple and modern, and it conveys a sense of innovation and technology.

## FEB 1 7 2006

### VII. 510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular §807.92, the following summary of information is provided:

#### A. Submitted by:

Lactitia Cousin Director of Regulatory Affairs and Quality Assurance NuVasive, Incorporated 4545 Towne Centre Court San Diego, California 92121 Telephone: [phone] Fax: [phone]

#### B. Device Name

| Trade or Proprietary Name: | NuVasive SmartPlate Gradient Plus System |
|----------------------------|----------------------------------------------|
| Common or Usual Name: | Cervical Plate and Screw System |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Device Class: | Class II |
| Classification: | §888.3060 |
| Product Code: | KWQ |

#### C. Predicate Devices

The subject SmartPlate Gradient Plus System is substantially equivalent to the SmartPlate Gradient CLP System currently distributed commercially in the U.S. by NuVasive.

#### D. Device Description

The Nu Vasive SmartPlate Gradient Plus System consists of a variety of plates, screws, and screw-retaining covers designed to provide stabilization as an adjunct to cervical fusion.

#### E. Intended Use

The NuVasive SmartPlate Gradient Plus System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neek pain of discogenic origin with the degeneration of the disc contirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.

WARNING: The NuVasive SmartPlate Gradient Plus System is not intended for screw attachment or fixation to the posterior clements (pedicles) of the cervical, thoracic or lumbar spine.

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Image /page/1/Picture/0 description: The image shows the logo for Nuvasive, a creative spine technology company. To the right of the logo is the text "K053581 2/2" in handwritten font. The text is slightly slanted and the numbers are written in a cursive style.

#### Comparison to Predicate Devices F.

The subject device has indications for use identical to those of its predicate, and employs the same principles of operation.

#### Summary of Non-Clinical Tests G.

Mechanical testing was presented.

#### Summary of Clinical Tests H.

(Not Applicable).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with three lines representing the head, body, and legs.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 7 2006

NuVasive, Inc c/o Ms. Laetitia Cousin Director of Regulatory Affairs and Quality Assurance 4545 Towne Centre Court San Diego, California 92121

Re: K053581

Trade/Device Name: NuVasive SmartPlate Gradient Plus System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: December 22, 2005 Received: December 27, 2005

Dear Ms. Cousin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sualou in the encreatives of the enactment date of the Medical Device Amendments, or to conninered processified 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). and Cosmetter rece (110) that to neview subject to the general controls provisions of the Act. The r ou may, diereleve, mains 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 If your device is bluesting (600 a00 of ols. Existing major regulations affecting your device can may be subject to back additions, 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 r that FDA has made a determination that your device complies with other requirements of the Act that 1191 has Intelles and regulations administered by other Federal agencies. You must or any I ederal barated and equirements, 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- Ms. Laetitia Cousin

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro neets (2) = ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = I ms letter will anow yourse ough finding of substantial equivalence of your device to a legally prematics notification: "The Dr. In aclassification 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 If you desire specific arrapliance at [phone]. 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 other general mionnation on Joan Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html.

Sincerely yours,

Huky Lewer 90

Mark N. Melkerson Acting 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

510(k) Number (if known):_

Device Name:____SmartPlate® Gradient™ Plus System

Indications For Use:

The NuVasive SmartPlate Gradient Plus System is intended for anterior screw fixation The Novaorve email. These implants have been designed to provide stabilization as an of the cervical fusion. Indications for the use of this implant system include aujunct to our noar rate pain of discogenic origin with the degenerative of the disc confirmed by history and radiographic studies, degeneration - of the - also - sessences, deformity, tumor, pseudarthrosis or failed previous fusion.

WARNING: The NuVasive SmartPlate Gradient Plus System is not intended for screw WANNING. The Navadiro onlart labr elements (pedicles) of the cervical, thoracic or lumbar spine.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Divisit Division of General, Restorative, and Neurological Devices

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