NUVASIVE LATERAL PLATE SYSTEM

K082070 · Nuvasive, Inc. · KWQ · Sep 24, 2008 · Orthopedic

Device Facts

• Record ID: K082070
• Device Name: NUVASIVE LATERAL PLATE SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Sep 24, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NuVasive Lateral Plate System is indicated for use as an adjunct to fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

Device Story

The NuVasive Lateral Plate System is a spinal fixation orthosis consisting of plates, screws, bolts, and lock nuts. It is used by surgeons during spinal fusion procedures to provide stabilization of the thoracic, thoracolumbar, and lumbosacral spine. Components are implanted via lateral, anterolateral, or anterior surgical approaches. The system allows for rigid locking of components to accommodate individual patient anatomy and pathology. The device provides mechanical stabilization to the spine, facilitating fusion and potentially reducing pain and instability associated with the specified spinal conditions.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

System includes plates, screws, bolts, and lock nuts for spinal fixation. Operates as a mechanical orthosis for intervertebral body fixation. No software or electronic components.

Indications for Use

Indicated for patients requiring spinal fusion for thoracic, thoracolumbar (T1-L5), or lumbosacral (L1-S1) instability caused by fracture, tumor, degenerative disc disease, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous surgery.

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.

Submission Summary (Full Text)

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# ONUVASIVE

Special 510(k) Premarket Notification Lateral Plate System

### 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

Han Fan Regulatory Affairs Associate NuVasive, Incorporated 4545 Towne Centre Court San Diego, California 92121 Telephone: [phone] Fax: [phone]

#### B. Device Name

| Trade or Proprietary Name: | NuVasive Lateral Plate System |
|----------------------------|----------------------------------------------|
| Common or Usual Name: | Spinal Implants |
| Classification Name: | Spinal Intervertebral Body Fixation orthosis |
| Device Class: | Class II |
| Classification: | §888.3060 |
| Product Code: | KWQ |

### C. Predicate Devices

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

#### D. Device Description

The NuVasive Lateral Plate System consists of a variety of plates, screws, bolts, and lock nut. Implant components can be rigidly locked to suit the individual pathology and anatomical conditions of the patient.

#### E. Intended Use

The NuVasive Lateral Plate System is indicated for use as an adjunct to fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (TI-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of fumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

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# NUVASIVE

## F. Substantial Equivalence

Data was provided which demonstrated the NuVasive Lateral 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

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 stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle. The logo is black and white.

SEP 2 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nu Vasive Incorporated % Ms. Laetitia Cousin Director of Regulatory Affairs and Quality Assurance 7475 Lusk Boulevard San Diego, California 92121

Re: K082070

Trade/Device Name: NuVasive Lateral Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 27, 2008 Received: August 28, 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 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. Wilkerson

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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K082070
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#### Indications for Use

510(k) Number (if known): _ K082070

Device Name: NuVasive Lateral Plate System

Indications For Use:

The NuVasive Lateral Plate System is indicated for use as an adjunct to fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbosacral (1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.

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)

Page 1 of 1
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number
4682070