SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System

K180156 · Globus Medical, Inc. · PEK · Mar 7, 2018 · Orthopedic

Device Facts

• Record ID: K180156
• Device Name: SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System
• Applicant: Globus Medical, Inc.
• Product Code: PEK · Orthopedic
• Decision Date: Mar 7, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SP-Fix® Spinous Process Fixation Plate 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. The SP-Fix® Spinous Process Fixation Plate is intended for use with allograft or autograft bone and is not intended for stand-alone use. The RELIEVE® Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The RELIEVE® Laminoplasty Fixation System is used to hold the allograft or autograft bone in place in order to prevent the graft from expulsion, or impinging the spinal cord.

Device Story

SP-Fix® and RELIEVE® are spinal fixation systems used by surgeons in clinical settings to provide supplemental stabilization or secure bone grafts during spinal procedures. SP-Fix® utilizes plates, rods, and barrels to attach to spinous processes for fusion support. RELIEVE® utilizes plates and screws to secure bone grafts in laminoplasty. Both systems are available in various sizes to accommodate patient anatomy. These devices are not stand-alone; they function as mechanical aids to support fusion or graft placement, directly assisting the surgeon in achieving spinal stability and preventing graft migration or spinal cord impingement.

Clinical Evidence

Bench testing only. Static and dynamic compression and static cantilever bending testing were performed on RELIEVE® plates in accordance with FDA guidance for spinal systems. No additional mechanical testing was required for SP-Fix® plates. No clinical data was provided.

Technological Characteristics

Spinal interlaminal fixation orthosis components (plates, rods, barrels, screws) manufactured from PEEK. Designed for posterior surgical approach. Systems are non-sterile, intended for use with allograft or autograft bone. No software or electronic components.

Indications for Use

Indicated for patients requiring spinal stabilization: SP-Fix® for T1-S1 supplemental fusion (DDD, spondylolisthesis, trauma, tumor) using allograft/autograft; RELIEVE® for C3-T3 laminoplasty to secure bone graft and prevent spinal cord impingement.

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 Plate (K102195, K132191)
• RELIEVE® Laminoplasty Fixation System (K080664)
• HAVEN® Laminoplasty System (K171413)
• Kalitec Direct InSePtion MIS Fixation System (K163471)

Reference Devices

• Anterior Spinal Devices PEEK (K152022)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 7, 2018

Globus Medical Inc. Ms. Lori Burns Director, Regulatory Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K180156

Trade/Device Name: SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK, NOW Dated: January 18, 2018 Received: January 19, 2018

Dear Ms. Burns:

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

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 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.

Ronald P. Jean -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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# Indications for Use

510(k) Number (if known) K180156

Device Name SP-Fix® Spinous Process Fixation Plate

#### Indications for Use (Describe)

The SP-Fix® Spinous Process Fixation Plate 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. The SP-Fix® Spinous Process Fixation Plate is intended for use with allograft or autograft bone and is not intended for stand-alone use.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <div><span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div><span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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# Indications for Use

510(k) Number (if known) K180156

Device Name RELIEVE® Laminoplasty Fixation System

#### Indications for Use (Describe)

The RELIEVE® Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The RELIEVE® Laminoplasty Fixation System is used to hold the allograft or autograft bone in place in order to prevent the graft from expulsion, or impinging the spinal cord.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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### 510(k) Summary: Additional PEEK Devices

| Company: | Globus Medical Inc.<br>2560 General Armistead Ave.<br>Audubon, PA 19403<br>610-930-1800 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact:<br>Secondary<br>Contact: | Lori Burns<br>Director, Regulatory Affairs |
| | Kelly J. Baker, Ph.D.<br>Senior Vice President, Regulatory and Clinical Affairs |
| Date Prepared: | January 18, 2018 |
| Device Name: | SP-Fix® Spinous Process Fixation Plate<br>RELIEVE® Laminoplasty Fixation System |
| Common Name: | Spinal Interlaminal Fixation Orthosis |
| Classification: | Per 21 CFR as follows:<br>§888.3050 Spinal Interlaminal Fixation Orthosis<br>Product Code(s):<br>PEK: SP-FIX®<br>NQW: RELIEVE®<br>Regulatory Class: II, Panel Code: 87 |
| Primary<br>Predicates: | SP-Fix® Spinous Process Fixation Plate (K102195, K132191)<br>RELIEVE® Laminoplasty Fixation System (K080664) |
| Predicates: | HAVEN® Laminoplasty System (K171413)<br>Kalitec Direct InSePtion MIS Fixation System (K163471) |

Reference Device: Anterior Spinal Devices PEEK (K152022)

### Purpose:

The purpose of this submission is to request clearance for an additional PEEK vendor and to update indications for SP-Fix® and RELIEVE®.

### Device Description:

#### SP-Fix®

The SP-Fix® Spinous Process Fixation Plate consists of plates, rods and barrels that are used to build a construct 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.

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### RELIEVE®

The RELIEVE® Laminoplasty Fixation System consists of spinal fixation plates and screws for use in laminoplasty procedures. RELIEVE® implants are inserted through a posterior cervical or thoracic approach, and are available in various sizes and geometric options to fit individual patient anatomy. Plates may be filled with bone graft material. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy.

# Indications for Use:

# SP-Fix®

The SP-Fix® Spinous Process Fixation Plate 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. The SP-Fix® Spinous Process Fixation Plate is intended for use with allograft or autograft bone and is not intended for stand-alone use.

# RELIEVE®

The RELIEVE® Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The RELIEVE® Laminoplasty Fixation System is used to hold the allograft or autograft bone in place in order to prevent the graft from expulsion, or impinqing the spinal cord.

### Performance Data:

Globus is not aware of any performance standards or special control as established to date for the above device or product code. Testing was conducted in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. Static and Dynamic Compression and Static Cantilever Bending testing performed on the RELIEVE® plates demonstrates substantial equivalence to the predicate devices. No additional mechanical testing for SP-Fix® plates was performed.

No further sterilization, biocompatibility and endotoxin evaluation and/or testing were required for this submission.

### Technological Characteristics:

SP-Fix® and RELIEVE® implants have the same technological characteristics as the predicate devices including design, intended use, material composition, function, and range of sizes.

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# Basis of Substantial Equivalence:

SP-Fix® and RELIEVE®implants have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject devices to the predicate devices.