EXPANDABLE LUMBAR INTERBODY SYSTEM

K130820 · Nu Vasive, Incorporated · MAX · Aug 8, 2013 · Orthopedic

Device Facts

• Record ID: K130820
• Device Name: EXPANDABLE LUMBAR INTERBODY SYSTEM
• Applicant: Nu Vasive, Incorporated
• Product Code: MAX · Orthopedic
• Decision Date: Aug 8, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NuVasive Expandable Lumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion. The Expandable Lumbar Interbody System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Expandable Lumbar Interbody System. The Expandable Lumbar Interbody System is intended to be used with supplemental internal spinal fixation systems (e.g. pedicle screw/rod systems) that are cleared by the FDA for use in the lumbar spine.

Device Story

Expandable lumbar interbody fusion implant; used for stabilization of lumbar spine segments. Implanted during spinal surgery; requires supplemental internal fixation (pedicle screw/rod systems). Facilitates fusion using autogenous bone graft. Available in various shapes/sizes to accommodate patient anatomy. Benefits patients by addressing discogenic back pain and degenerative disc disease. Surgeon-operated; used in clinical/OR settings.

Clinical Evidence

Bench testing only. Testing included static and dynamic axial compression, compression shear, and torsion per ASTM F2077; range of motion testing; lateral collapse testing; cadaver testing; and corrosion testing per ASTM F2129.

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F136, ISO 5832-3), Ti-6Al-4V (ASTM 1472), and Nitinol SE508 (ASTM F2063). Expandable interbody fusion device. Mechanical principle of operation. No software or electronic components.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) and up to Grade I spondylolisthesis at one or two contiguous lumbar levels (L2-S1). Requires prior 6-month non-operative treatment regimen. Must be used with autogenous bone graft and supplemental internal spinal fixation.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• NuVasive CoRoent® System (K071795)
• NLT Spine Ltd. Prow Fusion (K112359)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized graphic to the left of the word "NUVASIVE" in a sans-serif font. Below the company name is the tagline ":Speed of Innovation" in a smaller font. The logo is simple and modern, and the tagline suggests that the company is focused on innovation and speed.

## 510(k) Summary, K130820

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:

AUG 8 2013

Jeremy Markovich Senior Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: [phone]

Date Prepared: July 15, 2013

#### B. Device Name

| Trade or Proprietary Name: | Expandable Lumbar Interbody System |
|----------------------------|----------------------------------------------|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Spinal Intervertebral Body Fixation orthosis |

| Device Class: | Class II |
|-----------------|-------------------|
| Classification: | 21 CFR § 888.3080 |
| Product Code: | MAX |

#### C. Predicate Devices

The subject Expandable Lumbar Interbody System is substantially equivalent to the following predicate devices: NuVasive CoRoent® System (K071795) and NLT Spine Ltd. Prow Fusion (K112359).

#### D. Device Description

The NuVasive Expandable Lumbar Interbody System is manufactured from Ti-6Al-4V ELI conforming to ASTM F136 and ISO 5832-3, Ti-6A1-4V conforming to ASTM 1472, and Nitinol SE508 conforming to ASTM F2063. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

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Image /page/1/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized graphic to the left of the company name. Below the company name is the tagline "Speed of Innovation".

#### E. Intended Use

The NuVasive Expandable Lumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion.

The Expandable Lumbar Interbody System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Expandable Lumbar Interbody System. The Expandable Lumbar Interbody System is intended to be used with supplemental internal spinal fixation systems (e.g. pedicle screw/rod systems) that are cleared by the FDA for use in the lumbar spine.

#### F. Technological Characteristics

As was established in this submission, the subject Expandable Lumbar Interbody 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, and function.

#### G. Performance Data

Nonclinical testing was performed to demonstrate that the subject Expandable Lumbar Interbody System is substantially equivalent to other predicate devices. The following testing was performed:

- . Static and dynamic axial compression, compression shear, and torsion testing per ASTM F2077
- Range of Motion Testing .
- Lateral Collapse testing
- . Cadaver testing
- . Corrosion testing per ASTM F2129

The results demonstrate that the subject Expandable Lumbar Interbody System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate.

#### H. Conclusions

The subject Expandable Lumbar Interbody System has been shown to be substantially equivalent to legally marketed predicate devices in terms of safety and effectiveness, having similar indications for use, technological characteristics, and principles of operation as the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure embracing or supporting a globe-like shape.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

August 8, 2013

NuVasive, Incorporated Mr. Jeremy Markovich Senior Specialist. Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121

Re: K130820

Trade/Device Name: NuVasive® Expandable Lumbar Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 15, 2013 Received: July 16, 2013

Dear Mr. Markovich:

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. Iisting 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

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Page 2 - Mr. Jeremy Markovich

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.

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,

# Erin Keith

### For

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: NuVasive® Expandable Lumbar Interbody System

Indications For Use:

The NuVasive Expandable Lumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion.

The Expandable Lumbar Interbody System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Expandable Lumbar Interbody System. The Expandable Lumbar Interbody System is intended to be used with supplemental internal spinal fixation systems (e.g. pedicle screw/rod systems) that are cleared by the FDA for use in the lumbar spine.

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)

Anton E. Dmitriev, PhD Division of Orthopedic Devices