NUVASIVE HELIX REVOLUTION ACP SYSTEM

K093804 · Nuvasive, Inc. · KWQ · Feb 19, 2010 · Orthopedic

Device Facts

• Record ID: K093804
• Device Name: NUVASIVE HELIX REVOLUTION ACP SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Feb 19, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NuVasive HELIX Revolution 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 Revolution 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 Revolution 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. By providing mechanical stabilization, the system supports the fusion process, potentially reducing pain and restoring spinal stability for the patient. The device does not involve software or algorithmic processing.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Spinal intervertebral body fixation orthosis (Class II, 21 CFR 888.3060). System consists of metallic plates and screws for anterior cervical fixation. 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 (discogenic neck pain 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

• Helix ACP 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:

FEB 1 9 2010

Sheila Bruschi Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: [phone] Fax: [phone]

#### B. Device Name

Trade or Proprietary Name: NuVasive HELIX Revolution 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 Revolution ACP System is substantially equivalent to the Helix ACP System currently distributed commercially in the U.S. by Nu Vasive.

#### D. Device Description

The NuVasive HELIX Revolution 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 Revolution 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 Revolution 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/1 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 company name is the text "Creative Spine Technology" in a smaller font size. The logo is simple and modern.

#### 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.

#### 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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings forming a flowing, abstract shape.

## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

FEB 1 9 2010

Nu Vasive, Inc % Ms. Sheila Bruschi Regulatory Affairs Associate 7475 Lusk Boulevard San Diego, California 92121

Re: K093804

Trade/Device Name: NuVasive Helix Revolution ACP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: January 21, 2010 Received: January 22, 2010

Dear Ms. Bruschi:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Sheila Bruschi

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely your

Saukautmehm

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

Enclosure

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# Indications for Use

K093804 510(k) Number (if known):___

Device Name: HELIX Revolution Anterior Cervical Plating System

Indications For Use:

The NuVasive HELIX Revolution 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 Revolution 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)

signature

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K093804