ALIF Interfixated System

K151214 · Nu Vasive, Incorporated · OVD · Jun 25, 2015 · Orthopedic

Device Facts

• Record ID: K151214
• Device Name: ALIF Interfixated System
• Applicant: Nu Vasive, Incorporated
• Product Code: OVD · Orthopedic
• Decision Date: Jun 25, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The ALIF Interfixated System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with deseneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The ALIF Interfixated System is intended for use with autograft. The ALIF Interfixated System 10°-20° lordotic cages may be used as a standalone system. The ALIF Interfixated System 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the ALIF Interfixated System.

Device Story

Intervertebral body fusion device; consists of titanium alloy interbody cage and three bone screws; used for spinal fusion in lumbar spine. 10°-20° lordotic cages function as standalone systems; 25°-30° lordotic cages require supplemental posterior pedicle screw and rod fixation. Implanted by surgeons during spinal fusion procedures to stabilize vertebral segments and promote fusion using autograft. Benefits patients by addressing discogenic back pain and spinal instability.

Clinical Evidence

Bench testing only. Testing included static and dynamic compression/torsion (ASTM F2077), static push-out (ASTM Work Item Z8423Z), subsidence (ASTM F2267), and screw push-out testing. Results demonstrate performance equivalent to or better than predicate devices.

Technological Characteristics

Constructed from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and ISO 5832-3. System comprises interbody cage and three bone screws. Available in various lordotic angles (10°-30°). Mechanical fixation via integrated screws; supplemental posterior fixation required for 25°-30° variants. Non-active, implantable device.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous lumbar levels (L2-S1). Includes patients with up to Grade I spondylolisthesis or retrolisthesis and those with prior non-fusion spinal surgery. Requires 6 months of failed non-operative treatment.

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 Brigade® Hyperlordotic System (K123045)
• NuVasive CoRoent® XLR Standalone System (K100043)
• NuVasive CoRoent® Titanium System (K120918)
• NuVasive CoRoent® System (K071795)
• Surgicraft™ Limited STALIF® TT Intervertebral Body Fusion System (K073109)
• Centinel Spine™ Midline IITM / Midline II-Ti™ (K141942)

Submission Summary (Full Text)

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

June 25, 2015

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

Re: K151214

Trade/Device Name: NuVasive® ALIF Interfixated System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: May 5, 2015 Received: May 6, 2015

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Cynthia Adams

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Mark N. Melkerson -S

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) K151214

## Device Name

NuVasive® ALIF Interfixated System

### Indications for Use (Describe)

The ALIF Interfixated System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with deseneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The ALIF Interfixated System is intended for use with autograft. The ALIF Interfixated System 10°-20° lordotic cages may be used as a standalone system. The ALIF Interfixated System 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the ALIF Interfixated System.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in purple.

## 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:

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

Date Prepared: May 5, 2015

#### B. Device Name

| Trade or Proprietary Name: | NuVasive® ALIF Interfixated System |
|----------------------------|------------------------------------|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device |
| Device Class: | Class II |
| Classification: | 21 CFR § 888.3080 |
| Product Code: | OVD |

#### C. Predicate Devices

The subject NuVasive ALIF Interfixated System is substantially equivalent to the following devices:

Primary Predicate

- K123045 NuVasive Brigade® Hyperlordotic System ●
Additional Predicates

- K100043 NuVasive CoRoent® XLR Standalone System ●
- K120918 NuVasive CoRoent® Titanium System ●
- K071795 NuVasive CoRoent® System ●
- K073109 Surgicraft™ Limited STALIF® TT Intervertebral Body Fusion System ●
- K141942 Centinel Spine™ Midline IITM / Midline II-Ti™ ●

#### D. Device Description

The NuVasive ALIF Interfixated System is an interfixated interbody system manufactured from titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 and ISO 5832-3. The NuVasive ALIF Interfixated System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The ALIF Interfixated System consists of a titanium alloy interbody and three (3) titanium alloy bone screws. The ALIF Interfixated System 10° - 20° lordotic cages may be used as a standalone system. The ALIF Interfixated System 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

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Image /page/4/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in purple.

#### Indications for Use E.

The ALIF Interfixated System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The ALIF Interfixated System is intended for use with autograft.

The ALIF Interfixated System 10° - 20° lordotic cages may be used as a standalone system. The ALIF Interfixated System 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the ALIF Interfixated System.

#### F. Technological Characteristics

As was established in this subject ALIF Interfixated 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 ALIF Interfixated System is substantially equivalent to other predicate devices. The following testing was performed:

- Static and dynamic compression testing per ASTM F2077 ●
- Static and dynamic torsion testing per ASTM F2077 ●
- Static Push-out Testing per ASTM Work Item Z8423Z
- Subsidence Testing per ASTM 2267
- Screw Push-out Testing ●

The results of these studies show that the subject ALIF Interfixated System meets or exceeds the performance of the predicate device and does not introduce any new risks; therefore, the system is substantially equivalent to the predicate device.

#### H. Conclusions

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject ALIF Interfixated System has been shown to be substantially equivalent to legally marketed predicate devices.