SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS

K130478 · Globus Medical, Inc. · MAX · Jul 26, 2013 · Orthopedic

Device Facts

• Record ID: K130478
• Device Name: SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS
• Applicant: Globus Medical, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Jul 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as a lumbar intervertebral body fusion device, SUSTAIN® and SUSTAIN® Radiolucent (SUSTAIN®R) Spacers are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back 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) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The SUSTAIN® and SUSTAIN® R Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the REVERE®, REVOLVE™ or BEACON® Stabilization Systems. When used as a cervical intervertebral body fusion device, the SUSTAIN® and SUSTAIN®R Spacers are intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. 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. The SUSTAIN® and SUSTAIN®R Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE®, PROVIDENCE® or XTEND® Anterior Cervical Plate System. When used as a vertebral body replacement device, SUSTAIN® and SUSTAIN® R Spacers are intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material. SUSTAIN® and SUSTAIN® R Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Device Story

SUSTAIN® and SUSTAIN® R Spacers are spinal implants used for intervertebral body fusion or vertebral body replacement. Devices feature axial holes for packing autogenous bone graft and superior/inferior surface protrusions to grip vertebral endplates and resist expulsion. Spacers are implanted by surgeons in clinical settings using various approaches (posterior, transforaminal, anterior, anterolateral, or lateral). Devices provide structural stability and anterior spinal column support; they must be used with supplemental spinal fixation systems. Benefits include restoration of spinal column support and facilitation of fusion in patients with DDD, tumor, or trauma.

Clinical Evidence

Bench testing only. Mechanical testing including static and dynamic compression, static and dynamic torsion, static and dynamic compression shear, and subsidence was performed in accordance with the FDA guidance document for Intervertebral Fusion Devices.

Technological Characteristics

Materials: Commercially pure titanium or titanium alloy (ASTM F67, F136, F1295) for SUSTAIN®; PEEK polymer with titanium alloy or tantalum markers (ASTM F136, F560, F1295, F2026) for SUSTAIN® R. Form factor: Spacers with axial holes and surface protrusions. Energy source: None (mechanical implant).

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at 1-2 contiguous lumbar levels (L2-S1) or 1 cervical level (C2-T1) requiring fusion, or thoracolumbar (T1-L5) vertebral body replacement due to tumor or trauma.

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

• PATRIOT® Spacers (Lumbar) (K072970)
• PATRIOT® Spacers (Cervical) (K072991)
• PATRIOT® Transcontinental™ Spacers (Lumbar) (K093242)
• CALIBER™ Spacers (Lumbar) (K102293)
• SUSTAIN® Spacers (K031302)
• SUSTAIN® Radiolucent Spacers (K040284)
• COALITION® Spacers (K083389)
• BAK/Cervical (BAK-C®) Interbody Fusion System (P980048)

Submission Summary (Full Text)

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JUL 2 6 2013

## 510(k) SUMMARY: SUSTAIN® and SUSTAIN® Radiolucent Spacers

| Company: | Globus Medical Inc.<br>2560 General Armistead Ave.<br>Audubon, PA 19403<br>610-930-1800 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Christina Kichula<br>Group Manager, Regulatory Affairs |
| Date Prepared: | February 22, 2013 |
| Device Name: | SUSTAIN® and SUSTAIN® Radiolucent (SUSTAIN® R)<br>Spacers |
| Classification: | Per 21 CFR as follow:<br>§888.3060 Implant, fixation, spinal intervertebral body<br>fixation orthosis devices<br>§888.3080 Intervertebral Body Fusion device<br>Product Codes MQP, MAX, and ODP.<br>Regulatory Class II, Panel Code 87. |
| Predicate(s): | PATRIOT® Spacers (Lumbar) K072970<br>PATRIOT® Spacers (Cervical) K072991<br>PATRIOT® Transcontinental™ Spacers (Lumbar) K093242<br>CALIBER™ Spacers (Lumbar) K102293<br>SUSTAIN® Spacers K031302<br>SUSTAIN® Radiolucent Spacers K040284<br>COALITION® Spacers K083389<br>BAK/Cervical (BAK-C®) Interbody Fusion System P980048 |

## Purpose:

The purpose of this submission is to add intervertebral indications for SUSTAIN® and SUSTAIN® R Spacers and to make sterile spacers available.

## Device Description:

SUSTAIN® and SUSTAIN® R Spacers are devices that can be used as intervertebral fusion devices or as vertebral body replacement devices. These spacers are available in different shapes and heights to accommodate various surgical approaches and anatomical needs. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. Each spacer has an axial hole to allow grafting material to be packed inside the spacer.

These spacers are used to provide structural stability in skeletally mature individuals following discectomy, corpectomy, or vertebrectomy (including

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partial). Lumbar spacers may be inserted using a posterior, transforaminal, anterior, anterolateral, or lateral lumbar approach. Cervical spacers are inserted using an anterior cervical approach.

The SUSTAIN® Spacers are made from commercially pure titanium or titanium alloy as specified in ASTM F67, F136, and F1295.

The SUSTAIN® R Spacers are made from radiolucent peek polymer with titanium alloy or tantalum markers as specified in ASTM F136, F560, F1295, and F2026.

#### Indications for Use

When used as lumbar intervertebral body fusion devices, SUSTAIN® and SUSTAIN® Radiolucent (SUSTAIN® R) Spacers are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back 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) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The SUSTAIN® and SUSTAIN® R Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the REVERE®, REVOLVE™ or BEACON® Stabilization Systems.

When used as cervical intervertebral body fusion devices, the SUSTAIN® and SUSTAIN®R Spacers are intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. 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. The SUSTAIN® and SUSTAIN® R Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE®, PROVIDENCE® or XTEND® Anterior Cervical Plate System.

When used as vertebral body replacement devices. SUSTAIN® and SUSTAIN®R Spacers are intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material. SUSTAIN® and SUSTAIN® R Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

#### Performance Data

Mechanical testing (static and dynamic compression, static and dynamic torsion. static and dynamic compression shear, and subsidence) was conducted in

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accordance with the "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007. Performance and comparative analysis data demonstrate substantial equivalence to the predicate devices.

#### Basis for Substantial Equivalence:

SUSTAIN® and SUSTAIN® R Spacers are identical to the predicate SUSTAIN® and SUSTAIN® R Spacers with respect to design, technical characteristics, performance and vertebral body replacement indications for use. SUSTAIN® and SUSTAIN® R Spacers are equivalent to the predicate PATRIOT® Spacers with respect to intervertebral body fusion devices indications for use. The information provided within this premarket notification supports substantial equivalence to the predicate devices. SUSTAIN® and SUSTAIN® R Spacers are as safe, as effective, and perform as well as or better than predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

July 26, 2013

Globus Medical Incorporated % Ms. Christina Kichula Group Manager, Regulatory Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K130478

Trade/Device Name: SUSTAIN® and SUSTAIN® Radiolucent Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP, MQP Dated: June 25, 2013 Received: June 26, 2013

Dear Ms. Kichula:

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

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Page 2 - Ms. Christina Kichula

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincercly vours,

# Erin I. 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 Statement

K130478 510(k) Number:

SUSTAIN® and SUSTAIN® Radiolucent Spacers Device Name:

#### INDICATIONS

When used as a lumbar intervertebral body fusion device, SUSTAIN® and SUSTAIN® Radiolucent (SUSTAIN®R) Spacers are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back 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) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The SUSTAIN® and SUSTAIN® R Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the REVERE®, REVOLVE™ or BEACON® Stabilization Systems.

When used as a cervical intervertebral body fusion device, the SUSTAIN® and SUSTAIN®R Spacers are intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. 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. The SUSTAIN® and SUSTAIN®R Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE®, PROVIDENCE® or XTEND® Anterior Cervical Plate System.

When used as a vertebral body replacement device, SUSTAIN® and SUSTAIN® R Spacers are intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material. SUSTAIN® and SUSTAIN® R Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

X x OR Prescription Use (Per 21 CFR §801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(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