NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM

K072339 · Nuvasive, Inc. · KWQ · Oct 19, 2007 · Orthopedic

Device Facts

• Record ID: K072339
• Device Name: NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Oct 19, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NuVasive Anterior Lumbar Plate System is indicated for use via the lateral or anterclateral 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 lumbar 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.

Device Story

System consists of plates and screws for spinal fixation; components rigidly lock to accommodate patient-specific anatomy and pathology. Used by surgeons in clinical settings to treat spinal instability via lateral, anterolateral, or anterior surgical approaches. Provides mechanical stabilization of the spine to facilitate healing or correction of deformities. 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 system. No software, electronics, or energy sources.

Indications for Use

Indicated for patients requiring spinal stabilization in thoracic/thoracolumbar (T1-L5) or lumbar/lumbosacral (L1-S1) regions due to 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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JCT 1 9 2007

# 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:

Laetitia Cousin Director of Regulatory 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 Anterior Lumbar 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 NaVasive Anterior Lumbar Plate System consists of a variety of plates and screws. Implant components can be rigidly locked to suit the individual pathology and anatomical conditions of the patient.

#### E. Intended Use

The NuVasive Anterior Lumbar Plate System is indicated for use via the lateral or anterclateral 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 lumbar 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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# 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2007

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

Re: K072339

> Trade/Device Name: NuVasive Anterior Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: September 25, 2007 Received: September 26, 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 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

For

DEP

Mark N. Melkerson

10/15/07

Mark N. Melker Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Attachment

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K072339
Page 1 of 1

# Indications for Use

K072339 510(k) Number (if known):

Device Name: Anterior Lumbar Plate System

Indications For Use:

The NuVasive Anterior Lumbar Plate System is indicated for use 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 lumbar 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.

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 Revice Evaluation (ODE)

Division of General, Restorative, 1 and Neurological Devices

510(k) Number 1672339