NUVASIVE HELIX MINI ACP SYSTEM

K073275 · Nuvasive, Inc. · KWQ · Jan 29, 2008 · Orthopedic

Device Facts

• Record ID: K073275
• Device Name: NUVASIVE HELIX MINI ACP SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Jan 29, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NuVasive HELIX Mini 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 Mini 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

NuVasive HELIX Mini ACP System; cervical plate and screw system for anterior spinal stabilization. Used as adjunct to cervical fusion. Surgeon-operated in clinical/surgical settings. Provides mechanical fixation to stabilize cervical spine segments. Benefits patient by facilitating fusion in cases of degenerative disease, trauma, or deformity. Mechanical device; no software or electronic components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Spinal intervertebral body fixation orthosis consisting of metallic plates and screws. Mechanical fixation device. No software, electronics, or connectivity.

Indications for Use

Indicated for anterior cervical spine stabilization as an adjunct to fusion in patients with degenerative disc disease (discogenic neck pain 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

• HELIX ACT System

Submission Summary (Full Text)

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Image /page/0/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, lighter font.

# 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 and Clinical Affairs, and Quality Assurance NuVasive, Incorporated 4545 Towne Centre Court San Diego, California 92121 Telephone: [phone] Fax: [phone]

JAN 29 2002

### Device Name B.

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

## D. Device Description

The NuVasive HELIX Mini 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 Mini 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 Mini 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 Creative Spine Technology". The logo features the company name in bold, sans-serif font, with the tagline "Creative Spine Technology" in a smaller, lighter font underneath. To the left of the company name is a curved line that appears to be a stylized representation of a spine.

# F. Comparison to Predicate Devices

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.

# H. Summary of Clinical Tests

(Not Applicable).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three abstract, bird-like shapes stacked vertically, creating a sense of upward movement.

Public Health Service

JAN 2 9 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K073275

Trade/Device Name: Helix Mini 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: January 7, 2007 Received: January 8, 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, 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 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.

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# Page 2 - Ms. Laetitia Cousin

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 Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark H. Millman

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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K073275
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# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: HELIX Mini Anterior Cervical Plating System

Indications For Use:

The NuVasive HELIX Mini 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 Mini 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 X (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 Budup for you
(Division Sign-Off)
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(Division Sign-Off)

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**Division of General, Restorative, and Neurological Devices**

**510(k) Number** KD2325