NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM

K121837 · Nuvasive, Inc. · KWQ · Jul 16, 2012 · Orthopedic

Device Facts

• Record ID: K121837
• Device Name: NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Jul 16, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NuVasive Brigade Anterior 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 (TI-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L) I-Sl) 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 Brigade Anterior Plate System is an anterior/anterolateral thoracolumbar spinal fixation system. It consists of titanium alloy and Nitinol implant components, including plates and screws, and associated manual surgical instruments. The system is used by surgeons in an operating room setting to provide spinal stabilization. The surgeon selects appropriate implant sizes based on patient anatomy and pathology. The device is implanted to address spinal instability resulting from various conditions such as fractures, tumors, or degenerative disc disease. It functions as a mechanical fixation orthosis to support the spine during the healing process.

Clinical Evidence

Bench testing only. Static and dynamic compression and static torsion testing were performed per ASTM F1717 to demonstrate mechanical equivalence to predicate devices.

Technological Characteristics

System components manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136/ISO 5832-3 and Nitinol SE508 alloy per ASTM F2063. Mechanical fixation orthosis. No software or electronic components.

Indications for Use

Indicated for patients requiring stabilization of the thoracic, thoracolumbar, lumbar, or lumbosacral spine (T1-S1) due to fracture, tumor, degenerative disc disease, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous surgery. Used via lateral/anterolateral approach (T1-L5) or anterior approach (L1-S1).

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

• Halo® II Anterior Lumbar Plate System (K111866)
• NuVasive Anterior Lumbar Plate System (K072339)

Submission Summary (Full Text)

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# 510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

#### A. Submitted by:

Cynthia Adams Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 [phone]

JUL 16 2012

Date Prepared: June 21, 2012

## B. Device Name

| Trade or Proprietary Name: | NuVasive® Brigade® Anterior Plate System |
|----------------------------|----------------------------------------------|
| Common or Usual Name: | Anterior, Noncervical Spinal Implant |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |

Device Class: Classification: Product Code: Class II 21 CRF §888.3060 KWQ

#### C. Predicate Devices

The subject NuVasive Brigade Anterior Plate System is substantially equivalent to the following devices:

- KI11866 NuVasive, Inc. Halo® II Anterior Lumbar Plate System .
- . K072339 - NuVasive Anterior Lumbar Plate System

### D. Device Description

The NuVasive Brigade Anterior Plate System is an anterior/anterolateral, thoracolumbar system that consists of a variety of implant components including screws and plates, as well as associated manual general surgical instruments. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The subject device components are manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3, and Nitinol SE508 alloy conforming to ASTM F2063.

#### E. Intended Use

The NuVasive Brigade Anterior 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 (TI-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L) I-Sl) 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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Special 510(k) Premarket Notification Brigade® Anterior Plate System

### F. Technological Characteristics

JUVASIV

As was established in this submission, the subject Brigade Anterior Plate System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, and range of sizes.

#### G. Performance Data

Nonclinical testing was performed to demonstrate that the subject Brigade Anterior Plate System is substantially equivalent to other predicate devices. The following testing was performed:

- Static and dynamic compression testing per ASTM F1717
- . Static torsion testing per ASTM F1717

The results of these studies show that the subject Brigade Anterior Plate System meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent.

#### H. Conclusions

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject Brigade Anterior Plate System has been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

NuVasive, Incorporated % Ms. Cynthia Adams Regulatory Affairs Associate 7475 Lusk Boulevard San Diego, California 92121

JUL 16 2012

Re: K121837

Trade/Device Name: NuVasive® Brigade® Anterior Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: June 21, 2012 Received: June 22, 2012

Dear Ms. Adams:

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. Cynthia Adams

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eunice Keith

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

Enclosure

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:

Indications For Use:

The NuVasive Brigade Anterior 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, spinal stenosis, or a failed previous spine surgery.

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)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

K121837 510(k) Number_