FORTIFY® and FORTIFY® Integrated Corpectomy Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5). FORTIFY® Spacers (titanium) are also intended for use in the cervical spine (C2-T1). All FORTIFY® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

When used in the cervical spine (C2-T1), FORTIFY® devices (titanium) are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor fracture or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal tissues in cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

When used in the thoracolumbar spine (T1-L5), FORTIFY® Integrated devices are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.

These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

XPand® Corpectomy Spacers (including XPand®-R) are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). XPand® Corpectorny 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 system, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material. XPand® Corpectomy Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. All XPand® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

NIKO® Corpectomy Spacers are vertebral body replacement devices 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). NIKO® Corpectomy 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, and anterior screw and rod systems). The interior of the spacers can be packed with bone grafting material. NIKO® Corpectomy Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. All NIKO® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

When used as lumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R, and SUSTAIN®-IR) 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 at the involved level(s). SUSTAIN®, SUSTAIN® R and SUSTAIN®-IR Spacers are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. SUSTAIN® TPS Spacers are to be used with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the CREO®, REVERE®, REVOLVE®, or BEACON® Stabilization Systems.

When used as cervical intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R) 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 at least six (6) weeks of non-operative treatment. SUSTAIN® 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 Systems. All SUSTAIN® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

When used as vertebral body replacement devices, SUSTAIN® Spacers (including SUSTAIN® R TPS) are intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). The spacers are intended to be used with supplemental spinal frave 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 spacers can be packed with bone grafting material. SUSTAIN® Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. All SUSTAIN® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

COALITION® Spacers 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. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone, depending on the system.

The COALITION® Spacer is a stand-alone interbody fusion device intended for use at one or two levels of the cervical spine (C2-T1) and is to be used with two titanium alloy screws which accompany the implant. The spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The COALITION MIS™ Spacer is an interbody fusion device and is to be used with two titanium alloy screws or anchors which accompany the implants. When used with screws, COALITION MIS™ Spacers are stand-alone interbody fusion devices intended for use at one or two levels of the cervical spine (C2-T1). When used with anchors, COALITION MIS™ Spacers are intended for use at one level of the cervical spine (C2-T1) with additional supplemental fixation such as posterior cervical screw fixation. The spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The COALITION AGX™ Spacer is intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation. When used with the COALITION AGX™ Plate, the plate-spacer assembly takes on the indications for use of the COALITION AGX™ Spacer, with the COALITION AGX™ Plate acting as the supplemental fixation. The COALITION AGX™ Plate and Spacer assembly is a stand-alone device intended for use at one level of the cervical spine (C2-T1) and is to be used with two titanium alloy screws which accompany the implant. The spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The COALITION AGX™ Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), turnors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

COALITION® TPS Spacers are stand-alone interbody fusion devices intended for use at one level of the cervical spine (C2-T1) and are to be used with two titanium alloy screws which accompany the implants. The spacers are to be filled with autogenous bone graft.

PATRIOT® Spacers (including Constitution®, Signature®, TransContinental®, and TransContinental® M) are interbody fusion devices intents with degenerative disc disease (DDD) at one or two continuous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc as 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 at the involved level(s). PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation. All PATRIOT® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

PATRIOT® Spacers (including COLONIAL®) are interbody fusion devices 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 as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. All PATRIOT® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE® or PROVIDENCE® Anterior Cervical Plate Systems.

The ALTERA™ Spacer is an interbody fusion device 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 ALTERA™ Spacer is to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

The RISE® Spacer is a lumbar interbody fusion device 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 RISE® Spacer is to be filled with autogenous bone graft material. This device is intended to be used with supplemental fixation, such as the REVERE® or REVOLVE® Stabilization Systems.

CALIBER® Spacers are interbody fusion devices 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). All CALIBER® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

CALIBER® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the CREO®, REVERE® or REVOLVE® Stabilization Systems.

The ELSA™ Spacer is an interbody fusion device 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 ELSA™ Spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone, may be used with two bone screws, and is to be used with supplemental fixation. Hyperlordotic (≥20°) implants must be used with the two bone screws and supplemental fixation in addition to the bone screws.

LATIS® Spacers are interbody for 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).

LATIS® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

The MONUMENT™ Spacer is an interbody fusion device 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 MONUMENT™ Spacer is to be filled with autogenous bone graft material, and is to be used with four titanium alloy screws that accompany the implant. The device is intended to be used with supplemental fixation (i.e. pedicle screws, facet fixation).

InterContinental® Plate-Spacers are lateral lumbar interbody fusion devices 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 sketally 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). InterContinental® Plate-Spacers are to be filled with autogenous bone graff material, and are to be used with two titanium alloy screws which accompany the implant. These devices are intended to be used with supplemental fixation (e.g. pedicle or facet screw systems) in addition to the integrated screws. All InterContinental® TPS coated spacers are indicated for the same use as noncoated PEEK versions.

The MAGNIFY™ Spacer is an interbody fusion device 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 MAGNIFY™ Spacer is to be filled with autogenous bone graft material, and is to be used with supplemental fixation, such as the CREO®, REVERE® or REVOLVE® Stabilization Systems.

The MAGNIFY™-S Spacer is a stand-alone interbody fusion device 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 MAGNIFY™-S Spacer is to be filled with autogenous bone graft material, and is to be used with three titanium alloy screws that accompany each implant.

INDEPENDENCE® (including INDEPENDENCE MIS™, and INDEPENDENCE MIS AGX™ Spacers) are interbody fusion devices 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 at the involved level(s). INDEPENDENCE® Spacers are to be filled with autograft bone graft composed of cancellous and/ or corticocancellous bone. All INDEPENDENCE® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

INDEPENDENCE® are stand-alone interbody fusion devices intended to be used with three titanium alloy screws which accompany the implants.

INDEPENDENCE MIS™ are interbody fusion devices intended to be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation), Hyperlordotic implants (≥25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

INDEPENDENCE MIS AGX™ Integrated Spacer and INDEPENDENCE MIS AGX™ Integrated Ti Spacer are interbody fusion devices that may be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (≥25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

INDEPENDENCE MIS AGX™ Spacers are C-shaped, non-integrated PEEK spacers that are intended to be used with supplemental fixation (e.g. facet screws or posterior fixation). When used in conjunction with the INDEPENDENCE MIS AGX™ Integrated Ti Spacer, these devices become the INDEPENDENCE MIS AGX™ Integrated Spacer.

Device Description

Globus Medical's interbody fusion and vertebral body replacement devices are cervical, thoracic or lumbar devices used to provide structural stability in skeletally mature individuals following discectomy, corpectomy or vertebrectomy and may be inserted using an anterior, posterior, lateral or transforaminal approach. The devices are available in various heights and geometric options to accommodate surgical approaches and patient anatomy. Ridges on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. These devices are to be used in conjunction with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to be packed inside the device.

These devices are made from radiolucent PEEK polymer with titanium alloy or tantalum markers or titanium alloy, commercially pure titanium, titanium alloy, and cobalt chromium molybdenum al. Implants are also available with hydroxyapatite (HA) coating.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from Globus Medical Inc. to the FDA, focusing on updating the labeling for MRI compatibility of various intervertebral fusion and vertebral body replacement devices. It is not a study proving the performance of a device against specific acceptance criteria for a diagnostic AI/ML algorithm.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document, as it pertains to the MRI compatibility of physical implants, not a software algorithm.

However, I can extract the following relevant, albeit limited, information:

Area of Acceptance Criteria and Performance (related to MRI Compatibility):

The document states that MRI testing was performed per specific ASTM standards. While the specific numerical acceptance criteria (e.g., maximum displacement, temperature rise, artifact size) are not explicitly detailed in the provided text, the successful completion of these tests implies that the devices met the relevant acceptance criteria defined by these standards for MRI compatibility.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is the MRI testing conducted according to the following ASTM standards:

ASTM F2052:2006: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ASTM F2119:2007: Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
ASTM F2182:11a: Standard Test Method of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
ASTM F2213:2006: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment

The document explicitly states: "No further device performance testing was required for this submission. The performance testing remains the same for the subject and predicate devices." This implies that the results of these ASTM standard tests were deemed acceptable by the FDA for the purpose of updating the MRI compatibility labeling.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in numerical terms within the document for each specific test. The acceptance criteria are implicitly those defined by the referenced ASTM standards for MRI safety parameters (magnetic field interaction, heating, artifact size).
- Reported Device Performance: The document only states that "MRI testing was performed on the subject devices per the following ASTM Standards" and that "No further device performance testing was required." This indicates that the performance met the requirements for MRI compatibility, but specific quantitative results (e.g., measured displacement in Gauss/cm, specific heating in degrees Celsius, or artifact dimensions) are not provided.
Therefore, a full table with specific numerical criteria and performance cannot be created from this text.
Sample sized used for the test set and the data provenance:
- Sample Size: Not specified. The testing was done on the "subject devices," referring to the various types of implants listed (FORTIFY®, XPand®, NIKO®, SUSTAIN®, etc.). The number of individual implants tested for each type is not mentioned.
- Data Provenance: Not explicitly stated. This type of testing (MRI compatibility) is typically performed in a laboratory setting on the physical devices, not clinical data from patients.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study involving human experts establishing ground truth from clinical images. The "ground truth" for MRI compatibility is determined by physical measurements and adherence to engineering standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There's no adjudication process for this type of physical device testing.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This document is about the MRI compatibility of physical implants, not an AI/ML diagnostic device requiring an MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for MRI compatibility is established by the specifications and measurement techniques outlined in the referenced ASTM standards. This involves physical measurements of magnetic field interaction, temperature changes, and image artifacts, not clinical ground truth derived from patients or expert consensus.
The sample size for the training set:
- Not applicable. This is not a machine learning model, so there is no training set.
How the ground truth for the training set was established:
- Not applicable. There is no training set.

In summary, this document is a regulatory submission for physical medical devices and their MRI compatibility labeling, not for a software-based diagnostic device. Therefore, most of the questions pertaining to AI/ML device study design parameters are not addressed and are not relevant to the provided text.

Summary

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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 & 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.

December 21, 2017

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

Re: K171848

Trade/Device Name: FORTIFY® and FORTIFY® Integrated Corpectomy Spacers, XPand® Corpectomy Spacers, NIKO® Corpectomy Spacers, SUSTAIN® Spacers, COALITION® Spacers, PATRIOT® Lumbar Spacers, PATRIOT® Cervical Spacers, ALTERATM Spacers, RISE® Spacers, CALIBER® Spacers, ELSATM Spacers, LATIS® Spacers, MONUMENT™ Spacers, InterContinental® Plate-Spacers, MAGNIFY™ Spacers, INDEPENDENCE® Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, OVD, MOP, PLR, ODP, OVE, KWO Dated: November 17, 2017

Received: November 20, 2017

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

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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); 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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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Indications for Use

510(k) Number (if known) K171848

Device Name

FORTIF Y ® and FORTIF Y ® Integrated Corpectomy Spacers

Indications for Use (Describe)

The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.

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

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 infornation 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:

"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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Indications for Use

510(k) Number (if known) K171848

Device Name XPand® Corpectomy Spacers

Indications for Use (Describe)

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

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

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:

"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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Indications for Use

510(k) Number (if known) K171848

Device Name NIKO® Corpectomy Spacers

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

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

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.

"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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Indications for Use

510(k) Number (if known) K171848

Device Name SUSTAIN® Spacers

Indications for Use (Describe)

When used as lumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R, and SUSTAIN®-IR) 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 at the involved level(s). SUSTAIN®, SUSTAIN® R and SUSTAIN®-IR Spacers are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. SUSTAIN® TPS Spacers are to be used with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the CREO®, REVERE®, REVOLVE®, or BEACON® Stabilization Systems.

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

{6}------------------------------------------------

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

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{7}------------------------------------------------

Indications for Use

510(k) Number (if known) K171848

Device Name COALITION® Spacers

Indications for Use (Describe)

Type of Use ( Select one or both, as applicable )
☒ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED
Form Approved: OMB No. 0910-0120

{8}------------------------------------------------

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 reqarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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{9}------------------------------------------------

Indications for Use

510(k) Number (if known) K171848

Device Name PATRIOT® Lumbar Spacers

Indications for Use (Describe)

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

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

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

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{10}------------------------------------------------

Indications for Use

510(k) Number (if known) K171848

Device Name PATRIOT® Cervical Spacers

Indications for Use (Describe)

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

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

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{11}------------------------------------------------

Indications for Use

510(k) Number (if known) K171848

Device Name ALTERATM Spacers

Indications for Use (Describe)

The ALTERA™ Spacer is to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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{12}------------------------------------------------

Indications for Use

510(k) Number (if known) K171848

Device Name RISE® Spacers

Indications for Use (Describe)

The RISE® Spacer is to be filled with autogenous bone graft material. This device is intended to be used with supplemental fixation, such as the REVERE® or REVOLVE® Stabilization Systems.

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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{13}------------------------------------------------

Indications for Use

510(k) Number (if known) K171484

Device Name CALIBER® Spacers

Indications for Use (Describe)

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

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

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{14}------------------------------------------------

Indications for Use

510(k) Number (if known) K171848

Device Name ELSA™ Spacers

Indications for Use (Describe)

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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{15}------------------------------------------------

Indications for Use

510(k) Number (if known) K171848

Device Name LATIS® Spacers

Indications for Use (Describe)

LATIS® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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{16}------------------------------------------------

Indications for Use

510(k) Number (if known) K171848

Device Name MONUMENT™ Spacers

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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{17}------------------------------------------------

Indications for Use

510(k) Number (if known) K171848

Device Name InterContinental® Plate-Spacers

Indications for Use (Describe)

InterContinental® Plate-Spacers are lateral lumbar interbody fusion devices 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 sketally 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). InterContinental® Plate-Spacers are to be filled with autogenous bone graft material, and are to be used with two titanium alloy screws which accompany the implant. These devices are intended to be used with supplemental fixation (e.g. pedicle or facet screw systems) in addition to the integrated screws. All InterContinental® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

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)

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.

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{18}------------------------------------------------

Indications for Use

510(k) Number (if known) K171848

Device Name MAGNIFY™ Spacers

Indications for Use (Describe)

The MAGNIFY™ Spacer is an interbody fusion device 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 MAGNIFY™ Spacer is to be filled with autogenous bone graft material, and is to be used with supplemental fixation, such as the CREO®, REVERE® or REVOLVE® Stabilization Systems.

The MAGNIFY™-S Spacer is a stand-alone interbody fusion device 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 MAGNIFY™-S Spacer is to be filled with autogenous bone graft material, and is to be used with three titanium alloy screws that accompany each implant.

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------------------	------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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{19}------------------------------------------------

Indications for Use

510(k) Number (if known) K171848

Device Name INDEPENDENCE® Spacers

Indications for Use (Describe)

INDEPENDENCE® (including INDEPENDENCE MIS™, and INDEPENDENCE MIS AGX™ Spacers) are interbody fusion devices 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 at the involved level(s). INDEPENDENCE® Spacers are to be filled with autograft bone graft composed of cancellous and/ or corticocancellous bone. All INDEPENDENCE® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

INDEPENDENCE® are stand-alone interbody fusion devices intended to be used with three titanium alloy screws which accompany the implants.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

{20}------------------------------------------------

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

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{21}------------------------------------------------

510(k) Summary: MRI Compatibility for Intervertebral Fusion and Vertebral Body Replacement Implants

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
Primary Contact:	Lori BurnsDirector of Regulatory Affairs
Secondary Contact:	Kelly J. Baker, Ph.D.Senior Vice President, Regulatory and Clinical Affairs
Date Prepared:	December 20, 2017
Device Name:	FORTIFY® and FORTIFY® IntegratedCorpectomy SpacersXPand® Corpectomy SpacersNIKO® Corpectomy SpacersSUSTAIN® SpacersCOALITION® SpacersPATRIOT® Lumbar SpacersPATRIOT® Cervical SpacersALTERA™ SpacersRISE® SpacersCALIBER® SpacersELSA™ SpacersLATIS® SpacersMONUMENT™ SpacersInterContinental® Plate-SpacersMAGNIFY™ SpacersINDEPENDENCE® Spacers
Classification:	Per 21 CFR as follows:§888.3060 Spinal Intervertebral Body Fixation Orthosisand/or§888.3080 Intervertebral Body Fusion Device
	PLR FORTIFY® Corpectomy Spacers
	MQP FORTIFY® and FORTIFY® Integrated Corpectomy Spacers
	XPand® Corpectomy Spacers
	NIKO® Corpectomy Spacers
	SUSTAIN® Spacers (Cervical & Lumbar)
	MAX SUSTAIN® Spacers (Lumbar)
	PATRIOT® Spacers (Lumbar)

{22}------------------------------------------------

TransContinental® M ALTERA™ Spacers RISE® Spacers CALIBER® Spacers LATIS® Spacers MAGNIFY™ Spacers INDEPENDENCE® Spacers ODP SUSTAIN® Spacers (Cervical) COALITION AGX™ Spacers

PATRIOT® Spacers (Cervical) OVE COALITION® Spacers
COALITION AGX™ Spacers KWQ COALITION AGX™ Spacer
OVD ELSA™ Spacers MONUMENT™ Spacers InterContinental® Plate-Spacer MAGNIFY™ Spacers INDEPENDENCE® Spacers

Requlatory Class: II, Panel Code: 87

Primary Predicate: FORTIFY® I Corpectomy Spacers (K121107)

Additional

FORTIFY® Corpectomy Spacers (K112756) Predicates: XPand® Corpectomy Spacers (K060665) NIKO® Corpectomy Spacers (K072465) SUSTAIN® Spacers (K130478 & K151665) COALITION® Spacers (K151939) PATRIOT® Spacers (Lumbar) (K122097, K161223) PATRIOT® Spacers (Cervical) (K072991) ALTERA® Spacers (K140411) RISE® Spacers (K113447) CALIBER® Spacers (K123231) ELSA™ Spacers (K161379) LATIS® Spacers (K123913) MONUMENT® Spacers (K132559) InterContinental® Plate-Spacer (K103382, K161223) MAGNIFY™ Spacers (K142498) INDEPENDENCE® Spacers (K160597, K170157) TPS Spacers (K143578)

{23}------------------------------------------------

Purpose:

The purpose of this 510(k) is to update the labeling for MRI compatibility.

Device Description:

Indications for Use:

FORTIFY® and FORTIFY® Integrated Corpectomy Spacers

When used in the cervical spine (C2-T1), FORTIFY® devices (titanium) are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor fracture or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. with bone graft used at the surgeon's discretion.

When used in the thoracolumbar spine (T1-L5), FORTIFY® and FORTIFY® Integrated devices are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.

{24}------------------------------------------------

XPand® Corpectomy Spacers

XPand® Corpectomy Spacers (including XPand®-R) are vertebral body replacement devices 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). XPand® Corpectomy 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 system, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material. XPand® Corpectomy Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. All XPand®TPS coated spacers are indicated for the same use as non-coated PEEK versions.

NIKO® Corpectomy Spacers

NIKO® Corpectomy Spacers are vertebral body replacement devices 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). NIKO® Corpectomy 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 spacers can be packed with bone grafting material. NIKO® Corpectomy Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. All NIKO® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

SUSTAIN® Spacers

When used as lumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R, and SUSTAIN®-IR) 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). SUSTAIN®, SUSTAIN® R and SUSTAIN®-IR Spacers are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. SUSTAIN® TPS Spacers are to be used with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the CREO®, REVERE®, REVOLVE®, or BEACON® Stabilization Systems.

{25}------------------------------------------------

When used as cervical intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R) 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. SUSTAIN® 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 Systems. All SUSTAIN® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

When used as vertebral body replacement devices, SUSTAIN® Spacers (including SUSTAIN® and SUSTAIN® R TPS) are intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaqed, 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 spacers can be packed with bone grafting material. SUSTAIN® Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. All SUSTAIN® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

COALITION® Spacers

COALITION® Spacers 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 contiquous 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. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone, depending on the system.

{26}------------------------------------------------

cervical screw fixation. The spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The COALITION AGX™ Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: deqenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

PATRIOT® Lumbar Spacers

PATRIOT® Spacers (including Constitution®, Signature®, Continental®, TransContinental®, and TransContinental® M) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiquous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc as 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). PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation. All PATRIOT® TPS coated spacers are indicated for the same use as noncoated PEEK versions.

PATRIOT® Cervical Spacers

{27}------------------------------------------------

degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of nonoperative treatment. All PATRIOT® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

ALTERA™ Spacers

The ALTERA™ Spacer is an interbody fusion device 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 ALTERA™ Spacer is to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

RISE® Spacers

The RISE® Spacer is a lumbar interbody fusion device 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 RISE® Spacer is to be filled with autogenous bone graft material. This device is intended to be used with supplemental fixation, such as the REVERE® or REVOLVE® Stabilization Systems.

CALIBER® Spacers

CALIBER® Spacers are interbody fusion devices 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). All CALIBER® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

{28}------------------------------------------------

ELSA™ Spacers

The ELSA™ Spacer is an interbody fusion device 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 ELSA™ Spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone, may be used with two bone screws, and is to be used with supplemental fixation. Hyperlordotic (≥20°) implants must be used with the two bone screws and supplemental fixation in addition to the bone screws.

LATIS® Spacers

LATIS® Spacers are interbody fusion devices 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).

LATIS® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

MONUMENT® Spacers

The MONUMENT® Spacer is an interbody fusion device 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 MONUMENT® Spacer is to be filled with autogenous bone graft material, and is to be used with four titanium alloy screws that accompany the implant. The device is intended to be used with supplemental fixation (i.e. pedicle screws, facet fixation).

InterContinental® Plate-Spacers

{29}------------------------------------------------

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). InterContinental® Plate-Spacers are to be filled with autogenous bone graff material, and are to be used with two titanium alloy screws which accompany the implant. These devices are intended to be used with supplemental fixation (e.g. pedicle or facet screw systems) in addition to the integrated screws. All InterContinental® TPS coated spacers are indicated for the same use as noncoated PEEK versions.

MAGNIFY™ Spacers

The MAGNIFY™ Spacer is an interbody fusion device intended for use in patients with deqenerative disc disease (DDD) at one or two contiquous 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 MAGNIFY™ Spacer is to be filled with autogenous bone graft material, and is to be used with supplemental fixation, such as the CREO®, REVERE® or REVOLVE® Stabilization Systems.

The MAGNIFY™-S Spacer is a stand-alone interbody fusion device 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 MAGNIFY™-S Spacer is to be filled with autogenous bone graft material, and is to be used with three titanium alloy screws that accompany each implant.

INDEPENDENCE® Spacers

INDEPENDENCE® (including-INDEPENDENCE MIS™, and INDEPENDENCE MIS AGX™ Spacers) are interbody fusion devices 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). INDEPENDENCE® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. All INDEPENDENCE® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

{30}------------------------------------------------

INDEPENDENCE® are stand-alone interbody fusion devices intended to be used with three titanium alloy screws which accompany the implants.

INDEPENDENCE MIS™ are interbody fusion devices intended to be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (≥25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

Summary of Technological Characteristics as Compared to the Predicate

The technological characteristics remain the same between the subject devices and the predicate devices. No changes have been made to any of the devices. This submission is only to update the labeling to include Magnetic Resonance Imaging (MRI) information.

Performance Data:

MRI testing was performed on the subject devices per the following ASTM Standards:

ASTM F2052:2006 Standard Test Method for Measurement of Magnetically ● Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ASTM F2119:2007 Standard Test Method for Evaluation of MR Image ● Artifacts from Passive Implants
ASTM F2182:11a Standard Test Method of Measurement of Radio ● Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
ASTM F2213:2006 Standard Test Method for Measurement of Magnetically . Induced Torque on Medical Devices in the Magnetic Resonance Environment

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No further device performance testing was required for this submission. The performance testing remains the same for the subject and predicate devices.

No further sterilization, biocompatibility and endotoxin evaluation and/or testing were required for this submission. The sterilization, biocompatibility and endotoxin testing remains the same for the subject and predicate devices.

Basis of Substantial Equivalence:

The subject devices are substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
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.(b)
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.