NUVASIVE HELIX ACP SYSTEM

K071329 · Nuvasive, Inc. · KWQ · Aug 8, 2007 · Orthopedic

Device Facts

• Record ID: K071329
• Device Name: NUVASIVE HELIX ACP SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Aug 8, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NuVasive HELIX Anterior Cervical Plating 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 HELIX Anterior Cervical Plating System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Device Story

The NuVasive HELIX ACP System is a spinal intervertebral body fixation orthosis consisting of plates and screws. It is used by surgeons in an operating room setting to provide stabilization as an adjunct to cervical fusion. The device is implanted anteriorly to the cervical spine to address conditions such as degenerative disc disease, trauma, or deformity. It functions as a mechanical fixation system to support the fusion process. The device does not involve software or algorithmic processing.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Spinal intervertebral body fixation orthosis consisting of plates and screws. Mechanical fixation device. No software or electronic components.

Indications for Use

Indicated for anterior cervical spine stabilization as an adjunct to fusion in patients with 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.

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

• Gradient Plus System

Submission Summary (Full Text)

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# 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:

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

AUG - 8 2007

#### B. Device Name

| Trade or Proprietary Name: | NuVasive HELIX ACP 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 HELIX ACP System is substantially equivalent to the Gradient Plus System currently distributed commercially in the U.S. by NuVasive.

#### D. Device Description

The NuVasive HELIX ACP System consists of a variety of plates and screws designed to provide stabilization as an adjunct to cervical fusion.

#### E. Intended Use

The NuVasive HELIX ACP 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 HELIX ACP System is not intended for screw attachment or fixation to the posterior elements (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 medical device company. The logo features a stylized "N" with a curved line above it, followed by the word "NUVASIVE" in bold, sans-serif font. Below the company name is the tagline "Creative Spine Technology" in a smaller, italicized font.

## 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.

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

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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure with three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 8 2007

NuVasive, Incorporated % Ms. Laetitia Cousin Director of Regulatory Affairs, Clinical Affairs and Quality Assurance 4545 Towne Centre Court San Diego, California 92121

Re: K071329

> Trade/Device Name: NuVasive HELIX ACP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: July 20, 2007 Received: July 23, 2007

Dear Ms. Cousin:

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. Ilsting 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 - Ms. Laetitia Cousin

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Barbara Buehrig

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

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K071329
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# Indications for Use

KOZI329 510(k) Number (if known):

Device Name: HELIX Anterior Cervical Plating System

Indications For Use:

The NuVasive HELIX Anterior Cervical Plating 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 HELIX Anterior Cervical Plating System is not intended for screw attachment or fixation to the posterior 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)

Barbara Buellup for Mpd
Division Sign Off

Division of General, Restorative, and Neurological Devices

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510(k) Number k071329