NUVASIVE ACP4 SYSTEM

K062590 · Nuvasive, Inc. · KWQ · Jan 18, 2007 · Orthopedic

Device Facts

• Record ID: K062590
• Device Name: NUVASIVE ACP4 SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Jan 18, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NuVasive ACP4 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 ACP4 System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Device Story

NuVasive ACP4 System comprises plates, screws, and screw-retaining covers; provides anterior cervical spine stabilization as adjunct to fusion. Used by surgeons in clinical settings to address degenerative disc disease, trauma, deformity, and other spinal pathologies. Device functions as mechanical fixation hardware; no electronic or software components. Clinical benefit derived from stabilization of cervical spine segments to facilitate fusion. Surgeon selects appropriate hardware components based on patient anatomy and pathology; implants are secured to anterior cervical spine.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Spinal intervertebral body fixation orthosis consisting of plates, screws, and screw-retaining covers. Mechanical fixation device; no energy source, software, or connectivity. Sterilization method not specified.

Indications for Use

Indicated for anterior cervical spine fixation 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 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 Plus 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 graphic to the left of the word "NUVASIVE" in all caps. Below the word "NUVASIVE" is the text "Creative Spine Technology" in a smaller font. The logo is simple and modern, and the text is clear and easy to read.

# 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:

#### Submitted by: A.

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

JAN 1 8 2007

#### B. Device Name

| Trade or Proprietary Name: | NuVasive ACP4 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 ACP4System is substantially equivalent to the SmartPlate Gradient Plus System currently distributed commercially in the U.S. by NuVasive.

#### D. Device Description

The NuVasive ACP4 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 ACP4 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 ACP4 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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Y062590 Page 2 of 2

Image /page/1/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized "N" symbol to the left of the word "NUVASIVE" in bold, sans-serif font. Below the word "NUVASIVE" 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.

### 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 stylized eagle with its wings spread, and three human figures underneath the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JAN 1 8 2007

Re: K062590

> Trade/Device Name: NuVasive ACP4 System Regulation Number: 21 CFR §888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 09, 2006 Received: October 10, 2006

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, 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.

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Page 2 - Ms. Laetitia Cousin

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 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. 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 [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 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 yours,

Barbara Bush

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

K062590 510(k) Number (if known):

Device Name: ACP4 Anterior Cervical Plating System

Indications For Use:

The NuVasive ACP4 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 ACP4 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 Buchner for NKN
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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**510(k) Number** K062590