NUVASIVE LATERAL PLATE SYSTEM

K091071 · Nuvasive, Inc. · KWQ · May 8, 2009 · Orthopedic

Device Facts

• Record ID: K091071
• Device Name: NUVASIVE LATERAL PLATE SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: May 8, 2009
• 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 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 spinal plates and screws; used as adjunct to fusion. Implant components provide rigid fixation to address patient-specific spinal pathology and anatomy. Used by surgeons in clinical/OR settings. Provides mechanical stabilization of spine segments. Benefits patient by maintaining alignment and supporting fusion process.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Spinal intervertebral body fixation orthosis consisting of plates and screws. Mechanical testing performed per ASTM F1717.

Indications for Use

Indicated for patients requiring spinal fusion for thoracic/thoracolumbar (T1-L5) or lumbar/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.

Predicate Devices

• NuVasive Lateral Plate System (K070273)
• NuVasive Lateral Plate System (K061789)
• NuVasive Lateral Plate System (K082070)
• NuVasive Anterior Lumbar Plate System (K072339)

Submission Summary (Full Text)

{0}------------------------------------------------

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:

## Submitted by: A.

Ms. Han Fan Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: [phone] Fax: [phone] Email: [e-mail]

MAY - 8 2009

# B. Device Name

NuVasive Lateral Plate System Trade or Proprietary Name: Common or Usual Name: Spinal Implants Spinal Intervertebral Body Fixation Orthosis Classification Name: Device Class: Class II Classification: 888.3060 Product Code: K WQ

# C. Predicate Devices

| Predicate Device: | NuVasive Lateral Plate System, NuVasive Lateral Plate System, NuVasive Lateral Plate System, and NuVasive Anterior Lumbar Plate System |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K070273, K061789, K082070, and K072339 |
| Date of Concurrence: | April 3, 2008, August 10, 2006, September 24, 2008, and October 19, 2007 |

#### D. Device Description

The NuVasive Lateral 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.

{1}------------------------------------------------

## Intended Use E.

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 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.

## Comparison to Predicate Devices F.

The subject device has indications for use identical to those of its predicate, and employs the same principles of operation.

#### Summary of Non-Clinical Tests G.

All mechanical testing performed in full compliance with ASTM F1717 was presented.

- H. Summary of Clinical Tests (Not Applicable).

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract image of an eagle with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Public Health Service

MAY - 8 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NuVasive Inc. % Ms. Han Fan Regulatory Affairs Associate 7475 Lusk Boulevard San Diego, California

Re: K091071

Trade/Device Name: NuVasive Lateral Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: April 9, 2009 Received: April 16, 2009

Dear Ms. Fan:

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.

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 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.

{3}------------------------------------------------

Page 2- Ms. Han Fan

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

David Krone for

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

Enclosure

{4}------------------------------------------------

510(k) Number (if known): K091071

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 lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), turnor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scollosis, lordosis, spinal stenosis, or a failed previous spine surgery.

Prescription Use (Part 21 CFR 801 Subpart D)

510(k) Numbe

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

G. Hi for. MXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices