REVEL Spacers

K180909 · Globus Medical, Inc. · ODP · Dec 18, 2018 · Orthopedic

Device Facts

• Record ID: K180909
• Device Name: REVEL Spacers
• Applicant: Globus Medical, Inc.
• Product Code: ODP · Orthopedic
• Decision Date: Dec 18, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

REVEL™ Spacers (REVEL™ and REVEL™-S) are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. Hyperlordotic implants (≥20°) must be used with supplemental fixation to the two screws or anchors. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cortical, cancellous, and/or corticocancellous bone. The REVEL™ Spacer is an interbody fusion device intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation, for one or two levels of the cervical spine. The REVEL™-S Spacer is an integrated interbody fusion device intended to be used with two titanium alloy screws and/ or anchors which accompany the implant. When used with two screws, the REVEL™-S Spacer is a stand-alone interbody fusion device intended for use at one or two levels of the cervical spine. When used with any anchors, the REVEL™ S Spacer is intended for use at one level of the cervical spine with additional supplemental fixation such as posterior cervical screw fixation.

Device Story

REVEL™ Spacers are expandable, anterior cervical interbody fusion devices designed to provide structural stability following discectomy. Devices feature height expansion ranges and various footprints to accommodate patient anatomy; superior/inferior surface protrusions grip vertebral endplates to resist expulsion. REVEL™-S variant includes integrated titanium alloy screws/anchors for fixation. Used in cervical spine (C2-T1) for one or two levels. Implants are filled with autograft or allogenic bone graft to facilitate fusion. Operated by surgeons in clinical settings. Output is structural support for the spinal column; clinical decision-making involves surgical stabilization of DDD. Benefits include restoration of disc height and promotion of spinal fusion.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F2077, F2267, and F2025. Bacterial endotoxin testing per ANSI/AAMI ST-72:2011. MRI safety assessed per ASTM F2052, F2119, and F2182. No clinical data provided.

Technological Characteristics

Expandable interbody fusion device. Materials meet applicable standards for biocompatibility. Mechanical testing conducted per ASTM F2077, F2267, and F2025. Includes titanium alloy screws/anchors for REVEL™-S. Features height expansion mechanisms and surface protrusions for endplate fixation.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one or two contiguous levels. Requires prior 6 weeks of non-operative treatment. DDD defined as discogenic pain with radiographic confirmation. Hyperlordotic implants (≥20°) require supplemental 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

• Globus COALITION® Spacers (K173115)
• Spinal Elements Crystal (K153352)
• Medtronic PEEK Prevail (K153373)
• Globus SUSTAIN® Spacer (K130478)
• Sagico IBF System Arion Cervical (K161710)

Reference Devices

• Globus MAGNIFY™ Spacers (K142498)

Submission Summary (Full Text)

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December 18, 2018

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

Re: K180909

Trade/Device Name: REVEL™ Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, OVE Dated: November 29, 2018 Received: November 30, 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about mediation-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,

# Katherine D. Kavlock -S

for

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

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known

K180909

Device Name REVEL™ Spacers

#### Indications for Use (Describe)

REVEL™ Spacers (REVEL™ and REVEL™-S) are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. Hyperlordotic implants (≥20°) must be used with supplemental fixation to the two screws or anchors. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cortical, cancellous, and/or corticocancellous bone.

The REVEL™ Spacer is an interbody fusion device intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation, for one or two levels of the cervical spine.

The REVEL™-S Spacer is an integrated interbody fusion device intended to be used with two titanium alloy screws and/ or anchors which accompany the implant. When used with two screws, the REVEL™-S Spacer is a stand-alone interbody fusion device intended for use at one or two levels of the cervical spine. When used with any anchors, the REVEL™ S Spacer is intended for use at one level of the cervical spine with additional supplemental fixation such as posterior cervical screw fixation.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## K180909 510(k) SUMMARY: REVEL™ Spacers

| Company: | Globus Medical Inc.<br>2560 General Armistead Avenue.<br>Audubon, PA 19403<br>[phone] |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kelly J. Baker, Ph.D.<br>Senior Vice President, Regulatory and Clinical Affairs |
| Date Prepared: | November 29, 2018 |
| Device Name: | REVELTM Spacers |
| Common Name: | Cervical Intervertebral Body Fusion Device |
| Classification: | Per 21 CFR as follows:<br>§888.3080 Intervertebral Body Fusion Device.<br>Product Codes: ODP, OVE<br>Regulatory Class: II, Panel Code: 87 |
| Primary Predicate: | Globus COALITION® Spacers (K173115) |
| Additional<br>Predicates: | Spinal Elements Crystal (K153352)<br>Medtronic PEEK Prevail (K153373)<br>Globus SUSTAIN® Spacer (K130478)<br>Sagico IBF System Arion Cervical (K161710) |

Reference Device: Globus MAGNIFY™ Spacers (K142498)

## Purpose:

The purpose of this submission is to request clearance for REVEL™ Spacers.

## Device Description:

REVEL™ Spacers are expandable, anterior cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The devices are available in various height expansion ranges and footprints to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

The REVEL™-S Spacer is to be used with two screws and/or anchors that are inserted through the anterior portion of the implant into adjacent vertebral bodies.

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#### Indications for Use:

REVEL™ Spacers (REVELTM and REVEL™-S) are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. Hyperlordotic implants (≥20°) must be used with supplemental fixation in addition to the two screws or anchors. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cortical, cancellous, and/or corticocancellous bone.

The REVEL™ Spacer is an interbody fusion device intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation, for one or two levels of the cervical spine.

The REVEL™-S Spacer is an integrated interbody fusion device intended to be used with two titanium alloy screws and/or anchors which accompany the implant. When used with two screws, the REVEL™-S Spacer is a stand-alone interbody fusion device intended for use at one or two levels of the cervical spine. When used with any anchors, the REVEL™-S Spacer is intended for use at one level of the cervical spine with additional supplemental fixation such as posterior cervical screw fixation.

#### Technoloqical Characteristics:

REVEL™ Spacers have the same technological characteristics as the predicate devices including the materials, design, function, range of sizes and intended use.

## Performance Data:

Mechanical testing (static and dynamic compression, static and dynamic compression-shear, static and dynamic torsion, subsidence, weight loss analysis, and expulsion) for REVEL™ Spacers was conducted in accordance with the "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, ASTM F2025, ASTM F2077, and ASTM F2267 to demonstrate substantial equivalence to the predicate devices.

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. MRI testing was assessed on the subject devices per ASTM F2052, F2119, and F2182.

## Basis for Substantial Equivalence:

REVEL™ Spacers have been found to be substantially equivalent to the predicate systems with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject cervical interbody fusion devices to the predicate devices.