AERIAL™ Interspinous Fixation

K180817 · Globus Medical, Inc. · PEK · May 21, 2018 · Orthopedic

Device Facts

• Record ID: K180817
• Device Name: AERIAL™ Interspinous Fixation
• Applicant: Globus Medical, Inc.
• Product Code: PEK · Orthopedic
• Decision Date: May 21, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AERIAL™ Interspinous Fixation is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. AERIAL™ is intended for use with allograft bone and is not intended for stand-alone use.

Device Story

AERIAL™ Interspinous Fixation is an expandable, non-cervical, posterior spinal fixation device; provides supplemental stabilization to support fusion. Used in conjunction with allograft bone; not for stand-alone use. Implanted by surgeons in clinical settings. Device components available in various sizes to accommodate patient anatomy. Functions via plate fixation/attachment to spinous processes. Benefits patients by providing supplemental stability during the fusion process for conditions including degenerative disc disease, spondylolisthesis, trauma, and tumor.

Clinical Evidence

Bench testing only. Performance demonstrated through mechanical testing including axial compression, plate dissociation, offset torsion, and tension. Biocompatibility confirmed via materials meeting applicable standards. Bacterial endotoxin testing performed per ANSI/AAMI ST-72:2011.

Technological Characteristics

Expandable interspinous fixation device; posterior non-pedicle design. Materials meet applicable standards for biocompatibility. Mechanical performance validated via axial compression, plate dissociation, offset torsion, and tension testing. Sterilization method not specified.

Indications for Use

Indicated for patients requiring supplemental spinal fusion at a single level in the non-cervical spine (T1-S1) due to degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), or tumor. Must be used with allograft bone; not for stand-alone use.

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

• SP-Fix® Spinous Process Fixation System (K180156)
• SP-Fix® Spinous Process Fixation System (K102195)
• SP-Fix® Spinous Process Fixation System (K132191)
• Alphatec BridgePoint (K103205)
• CD HORIZON SPIRE (K163301)

Submission Summary (Full Text)

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## 510(k) Summary: AERIAL™ Interspinous Fixation

| Company: | Globus Medical Inc.<br>2560 General Armistead Ave.<br>Audubon, PA 19403<br>610-930-1800 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kelly J. Baker, Ph.D.<br>Senior Vice President, Regulatory and Clinical Affairs |
| Date Prepared: | March 28, 2018 |
| Device Name: | AERIAL™ Interspinous Fixation |
| Common Name: | Spinal interlaminal fixation orthosis |
| Classification: | Per 21 CFR as follows:<br>§888.3050 Spinal interlaminal fixation orthosis<br>Product Code: PEK<br>Regulatory Class: II |
| Primary Predicate: | SP-Fix® Spinous Process Fixation System (K180156) |
| Additional<br>Predicates: | SP-Fix® Spinous Process Fixation System (K102195, K132191)<br>Alphatec BridgePoint (K103205)<br>CD HORIZON SPIRE (K163301) |

#### Purpose:

The purpose of this submission is to request clearance of AERIAL™ Interspinous Fixation.

#### Device Description:

AERIAL™ Interspinous Fixation is an expandable non-cervical interspinous fixation device used to provide supplemental stabilization of spinal segments to support fusion. The components are available in a range of sizes to fit the anatomical needs of a variety of patients.

#### Indications for Use:

The AERIAL™ Interspinous Fixation is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. AERIAL™ is intended for use with allograft bone and is not intended for stand-alone use.

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#### Performance Data:

Testing was conducted to demonstrate performance in axial compression, plate dissociation, offset torsion, and tension.

Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011. Biocompatibility of patient-contacting materials was demonstrated by using materials that meet applicable standards or are used in 510(k) cleared devices.

#### Technoloqical Characteristics:

Subject AERIAL™ implants have the same technological characteristics as the predicate devices including design, intended use, material composition, function, and range of sizes.

#### Basis of Substantial Equivalence:

AERIAL™ Interspinous Fixation has been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided supports substantial equivalence to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Globus Medical Inc. Kelly J. Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Ave. Audubon, Pennsylvania 19403

Re: K180817

Trade/Device Name: AERIALTM Interspinous Fixation Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: Class II Product Code: PEK Dated: March 28, 2018 Received: March 29, 2018

### Dear Dr. Baker:

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 forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

Enclosure

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