SPINOUS PROCESS PLATE SYSTEM

K073278 · Nuvasive, Inc. · KWP · Mar 28, 2008 · Orthopedic

Device Facts

• Record ID: K073278
• Device Name: SPINOUS PROCESS PLATE SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Mar 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NuVasive® Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies; spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. It is not intended for stand-alone use.

Device Story

NuVasive Spinous Process Plate System; posterior, non-pedicle supplemental fixation device for non-cervical spine (T1-S1). Device consists of plates with integrated spikes to resist rotation post-implantation. Used by surgeons in clinical settings to facilitate spinal fusion; requires attachment to spinous process. Not intended for stand-alone use; must be used with other fixation systems. Benefits include stabilization of spinal segments during fusion process.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Posterior, non-pedicle spinal fixation system. Features plates with integrated spikes for anti-rotation. Class II device (21 CFR 888.3050).

Indications for Use

Indicated for patients requiring supplemental spinal fusion in the non-cervical spine (T1-S1) due to degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), or tumor. Not for stand-alone use.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Submission Summary (Full Text)

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K073278

Image /page/0/Picture/1 description: The image shows the logo for Nuvasive, a medical device company specializing in spine surgery. The logo features a stylized arc above the letters "NUVASIVE" in a bold, sans-serif font. Below the company name is the tagline "Creative Spine Technology" in a smaller, italicized font.

#### 5. 510(K) SUMMARY

# MAR 2 8 2008

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:

### A. Submitted by

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]

#### B. Device Name

| Trade or Proprietary Name: | NuVasive® Spinous Process Plate System |
|----------------------------|----------------------------------------|
| Common or Usual Name: | Spinal Implants |
| Classification Name: | Spinal Interlaminal Fixation Orthosis. |
| Device Class: | Class II |
| Classification: | §888.3050 |
| Product Code: | KWP |

## C. Predicate Devices

The subject device is substantially equivalent to similar previously cleared devices.

#### D. Device Description

The NuVasive® Spinous Process Plate System features plates with spikes under the plate to help resist plate rotation after implantation.

#### E. Intended Use

The NuVasive® Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies; spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. It is not intended for stand-alone use.

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# F. Substantial Equivalence

Data was provided which demonstrated the NuVasive® Spinous Process Plate System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, design, material, and function.

- 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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2008

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

Re: K073278

Trade/Device Name: NuVasive® Spinous Process Plate System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: March 5, 2008 Received: March 6, 2008

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

Sincerely yours,

Mark N 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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#### 4. INDICATIONS FOR USE

510(k) Number (if known):

Device Name: NuVasive® Spinous Process Plate System

Indications for Use:

The NuVasive® Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies; spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. It is not intended for stand-alone use.

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)

(Division Sigh Division of General, Restorative, and Neurological Devices

510(k) Number K073278

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