LAMINOPLASTY FIXATION SYSTEM

K091623 · Nuvasive, Inc. · NQW · Oct 9, 2009 · Orthopedic

Device Facts

• Record ID: K091623
• Device Name: LAMINOPLASTY FIXATION SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: NQW · Orthopedic
• Decision Date: Oct 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NuVasive Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Laminoplasty Fixation System is used to hold the allograft material in place in order to prevent the allograft material from expulsion, or impinging the spinal cord.

Device Story

System consists of plates and screws for rigid fixation in laminoplasty procedures; used in lower cervical and upper thoracic spine (C3-T3). Device holds allograft material in place to prevent expulsion or spinal cord impingement. Operated by surgeons in clinical/OR settings. Mechanical fixation system; no electronic or software components.

Clinical Evidence

Bench testing only; no clinical data presented.

Technological Characteristics

Spinal interlaminal fixation orthosis consisting of plates and screws. Rigid locking mechanism. Materials and design equivalent to predicate.

Indications for Use

Indicated for patients undergoing laminoplasty procedures in the lower cervical and upper thoracic spine (C3 to T3) to secure allograft material and prevent expulsion or spinal cord impingement.

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.

Predicate Devices

• Synthes Arch System (K032534)

Submission Summary (Full Text)

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K091623

# Onuvasive

510(k) Premarket Notification Laminoplasty Fixation System

## 5. 510(K) SUMMARY

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

Ms. Han Fan Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Boulevard San Diego, California 92121 Telephone: [phone] Fax: [phone]

OCT - 9 2009

## B. Device Name

| Trade or Proprietary Name: | NuVasive Laminoplasty Fixation System |
|----------------------------|---------------------------------------|
| Common or Usual Name: | Interlaminal Fixation Appliance |
| Classification Name: | Spinal Interlaminal Fixation Orthosis |
| Device Class: | Class II |
| Classification: | §888.3050 |
| Product Code: | NQW |

### C. Predicate Devices

The subject device is substantially equivalent to similar previously cleared device. Synthes's Arch™ System (K032534) that is currently distributed commercially in U.S.

#### D. Device Description

The NuVasive Laminoplasty Fixation System consists of different sizes of plates and screws that can be rigidly locked to suit the individual pathology and anatomical conditions of the patient.

#### E. Intended Use

The NuVasive Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Laminoplasty Fixation System is used to hold the allograft material in place in order to prevent the allograft material from expulsion, or impinging the spinal cord.

#### F. Substantial Equivalence

Data was provided which demonstrated the NuVasive Laminoplasty 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/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with three wing-like shapes, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

NuVasive, Incorporated % Ms. Han Fan Regulatory Affairs Specialist 7475 Lusk Boulevard San Diego, California 92121

Re: K091623

Trade/Device Name: NuVasive® Laminoplasty Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: NOW Dated: September 25, 2009 Received: September 28, 2009

OCT - 9 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 cquivalent (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 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. Han Fan

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/ReportaProblem/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/defaulthtm.

Sincerely yours,

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

Enclosurc

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4. INDICATIONS FOR USE

510(k) Number (if known): K091623

Device Name: NuVasive® Laminoplasty Fixation System

Indications for Use:

The NuVasive Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Laminoplasty Fixation System is used to hold the allograft material in place in order to prevent the allograft material from expulsion, or impinging the spinal cord.

Prescription Use X (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)

vice Evaluation (ODE)

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

510(k) Number /K09/623