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 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® 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.

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.

Device Description

FORTIFY® and FORTIFY® Integrated Corpectomy Spacers are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The components include a central core and endplates, which are available in a range of sizes and options to accommodate the anatomical needs of a wide variety of patients. The core and endplates can be preoperatively or intraoperatively assembled to best fit individual requirements. Each spacer has an axial hole to allow autograft or allograft to be packed inside the spacer. Protrusions (teeth) on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. Additional spikes are available on some implants. FORTIFY® Integrated (FORTIFY® I) endplates have an integrated plate to accommodate screws for additional fixation and are assembled to the core.

AI/ML Overview

This document is a 510(k) summary for Globus Medical Inc.'s FORTIFY® Corpectomy Spacers, requesting additional indications for use in the cervical spine. It does not describe a study that proves the device meets specific acceptance criteria in the format typically used for AI/ML device evaluations (e.g., sensitivity, specificity, AUC, human reader improvement).

Instead, this document focuses on demonstrating substantial equivalence to predicate devices through design, intended use, material composition, function, and range of sizes. The "performance data" section refers to mechanical testing and bacterial endotoxin testing, which are standard for implantable medical devices but not related to software/AI performance metrics. The "clinical literature" section indicates a review was performed to support safety, rather than a prospective clinical study with specific endpoints for the device itself.

Therefore, most of the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable to this 510(k) submission.

Here's a breakdown of what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Criteria	Reported Device Performance
Mechanical Performance	N/A (Guidance documents and ASTM standards followed)	Static and dynamic compression, torsion, subsidence, and expulsion testing conducted successfully.
Bacterial Endotoxin	N/A (ANSI/AAMI ST-72:2011 followed)	Bacterial endotoxin testing (BET) conducted successfully.
Clinical Safety/Effectiveness	N/A (Equivalence to predicate devices)	Clinical literature review determined the safety profile to be equivalent to predicate devices.
Substantial Equivalence	Equivalent design, intended use, materials, function, and dimensions to predicate devices.	Device possesses these characteristics relative to the predicate devices.

Note: The document does not specify quantitative acceptance criteria (e.g., minimum compression strength, endotoxin limits) but rather states that tests were conducted in accordance with relevant standards and guidance, implying successful completion.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not applicable. The document describes mechanical and bacterial endotoxin testing, not a clinical test set with human subjects or a dataset for an AI model.
Data Provenance: Not applicable in the context of clinical data for AI/ML. Mechanical testing data would be generated in a lab setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable. Ground truth as typically defined for AI/ML (e.g., clinical diagnosis) is not relevant here.
Qualifications of Experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This is not a study requiring adjudication of expert interpretations.

5. 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:

No. This is a submission for an implantable medical device, not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Mechanical Testing & Bacterial Endotoxin Testing: The "ground truth" would be established by the specifications in the relevant ASTM standards (F2077, F2267) and ANSI/AAMI ST-72:2011, which define acceptable performance parameters.
Clinical Literature Review: The basis for demonstrating safety and efficacy is established through existing published clinical literature on similar devices and procedures.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/ML device.

Summary

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

November 9, 2017

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

Re: K162315

Trade/Device Name: FORTIFY® Corpectomy Spacers Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MOP, PLR Dated: November 3, 2017 Received: November 6, 2017

Dear Dr. Baker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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" (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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Katherine D. Kavlock -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K162315

Device Name FORTIFY® Corpectomy Spacers

Indications for Use (Describe)

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 corpectorny 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.

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

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510(k) Summary: FORTIFY® Corpectomy Spacers

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
Contact:	Kelly J. Baker, Ph.D.Senior Vice President, Regulatory and Clinical Affairs
Date Prepared:	November 8, 2017
Device Name:	FORTIFY® Corpectomy Spacers
Classification:	Per 21 CFR as follows:§888.3060 Spinal Intervertebral Fixation OrthosisProduct Code: MQP, PLRRegulatory Class: II, Panel Code: 87

Primarv Predicate: NuVasive X-Core Mini (K151651)

Additional	FORTIFY® Corpectomy Spacers (K112756)
Predicates:	Cardinal Spine C-VBR (K152568)

Purpose:

The purpose of this submission is to request additional indications for FORTIFY® Corpectomy Spacers (titanium) for use in the cervical spine.

Device Description

Indications for Use:

FORTIFY® and FORTIFY® Integrated Corpectorny 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

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T1). All FORTIFY® TPS coated spacers are indicated for the same use as noncoated 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 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.

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.

Performance Data:

Mechanical testing (static and dynamic compression and torsion, subsidence, and expulsion) was conducted in accordance with the "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, ASTM F2077, and ASTM F2267 and provided in the predicate submissions to demonstrate substantial equivalence. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.

Clinical Literature:

A clinical literature review was performed to support the use of the subject devices in the cervical spine. The risks of cervical use were identified and mitigated through design and surgical technique. Based on clinical literature, it was determined that the safety profile of the subject devices is equivalent to that of the predicate devices.

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Technological Characteristics:

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

Conclusions:

FORTIFY® Corpectomy Spacers have the same intended use, the same indications for use, similar technological characteristics and design, similar materials, and the same principles of operation as the predicate devices.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.