FORTIFY™ and FORTIFY™-R 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). These devices 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 autogenous bone graft or allograft. These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Device Description

FORTIFY™ and FORTIFY™-R 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 heights and footprints to accommodate the anatomical needs of a wide variety of patients. The components can be preoperatively or intraoperatively assembled to best fit individual requirements. Each spacer has an axial hole to allow autogenous bone graft or allograft to be packed inside of 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™ Corpectorny Spacers are manufactured from titanium alloy per ASTM F67, F136, and F1295. FORTIFY™-R Corpectorny Spacers are manufactured from radiolucent PEEK OPTIMA LT1, with titanium alloy and tantalum components, per ASTM F2026, F67, F136, F1295, and F560.

AI/ML Overview

The provided document is a 510(k) Summary for the FORTIFY™ and FORTIFY™-R Corpectomy Spacers, which are vertebral body replacement devices. The purpose of this submission is to request clearance for these devices. The document describes the device, its intended use, and the basis of substantial equivalence to predicate devices. It relies on mechanical testing to demonstrate substantial equivalence, rather than a clinical study involving human or animal subjects.

Here's an analysis based on your request, focusing on what is stated and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Not explicitly stated as numerical targets in this summary)	Reported Device Performance
Mechanical Testing	Compliance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 and ASTM F2077 for demonstrating substantial equivalence.	Was conducted for: - Static compression - Dynamic compression - Static torsion - Dynamic torsion - Expulsion
Material Properties	Specification for materials (e.g., Titanium alloy per ASTM F67, F136, F1295; PEEK OPTIMA LT1 per ASTM F2026, F67, F136, F1295, F560)	FORTIFY™: Manufactured from titanium alloy per ASTM F67, F136, and F1295.FORTIFY™-R: Manufactured from radiolucent PEEK OPTIMA LT1, with titanium alloy and tantalum components, per ASTM F2026, F67, F136, F1295, and F560.
Design Characteristics	Accommodation of anatomical needs, axial hole for bone graft, protrusions/spikes to resist expulsion.	Devices include a central core and endplates in a range of heights and footprints. Each spacer has an axial hole. Protrusions (teeth) on superior and inferior surfaces grip endplates. Additional spikes available on some implants.
Intended Use	Use in thoracolumbar spine (T1-L5) for vertebral body replacement due to tumor or trauma, with supplemental fixation, and ability to pack with bone graft.	Meets the stated Indications for Use.

Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is described as Mechanical testing. This testing was performed in accordance with standards cited: "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 and ASTM F2077. The purpose of this testing was to "demonstrate substantial equivalence to the predicate system(s)."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. For mechanical testing of medical devices, the "sample size" typically refers to the number of devices or components subjected to each test condition. This information is usually detailed in the full test report, not typically in the summary.
Data Provenance: This is mechanical test data, not clinical data from patients. Therefore, concepts like "country of origin of the data," "retrospective or prospective" do not apply in the same way they would for a clinical study. The data would originate from the testing laboratory where the mechanical tests were performed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the evaluation relies on objective mechanical testing against engineering standards and material specifications, not on expert-adjudicated clinical data or "ground truth" derived from human experts in the context of diagnostic interpretation.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation relies on objective mechanical testing against engineering standards. Adjudication methods like 2+1 or 3+1 are used for human expert reviews, typically in clinical studies to establish a consensus ground truth, which is not the case here.

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

This information is not applicable. The device is a physical spinal implant, not an AI diagnostic tool or system designed to assist human readers (e.g., radiologists) in interpreting medical images. Therefore, an MRMC study and AI assistance metrics are irrelevant.

6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable. As previously mentioned, this is a physical medical device (spinal implant), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by validated engineering standards and guidance documents. For instance, ASTM F2077 defines test methods for spinal implants, and the "Guidance for Spinal System 510(k)s" provides the framework for demonstrating substantial equivalence through mechanical performance. The device's performance measured during mechanical testing is compared against the requirements and benchmarks implied by these standards for predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. This is mechanical testing for a physical device, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above (not a machine learning model).

Summary

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OCT - 7 2011

510(k) Summary: FORTIFY™ Corpectomy Spacers

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403(610) 930-1800
Contact:	Kelly J. Baker, Ph.D.Vice President. Regulatory and Clinical Affairs

Date Prepared: September 20, 2011

Device Name: FORTIFY™ and FORTIFY™-R Corpectomy Spacers

Classification: Per 21 CFR as follows: §888.3060 Implant, fixation, spinal intervertebral body fixation orthosis devices Product Code MQP. Regulatory Class II, Panel Code 87.

XPand® and XPand® Radiolucent Corpectomy Spacers Predicate(s): (K050850 and K060665), Stryker Spine VLIFT® Vertebral Body Replacement System (K060506) and Synthes SynMesh® Spacers (K003275 & K041389)

Purpose:

ﺘ

K112756

The purpose of this submission is to request clearance for the FORTIFY™ and FORTIFY TM-R Corpectomy Spacers.

Device Description:

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K112756

Indications for Use:

Performance Data:

Mechanical testing (static and dynamic compression, static and dynamic torsion and expulsion) was conducted in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 and ASTM F2077 to demonstrate substantial equivalence to the predicate system(s).

Basis of Substantial Equivalence:

FORTIFY™ and FORTIFY™-R Corpectomy Spacers implants are similar to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject spacer to the predicate device(s).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the caduceus symbol. The image is in black and white.

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

OCT - 7 2011

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

Re: K112756

Trade/Device Name: FORTIFY" and FORTIFY"-R Corpectomy Spacers Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: September 20, 2011 Received: September 26, 2011

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

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Page 2 – Kelly J. Baker, Ph.D.

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/MedicalDeyices/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours,

Rumon mpy

Mark N. Melkerson
Director
Division of Surgical, Orthopedic
and Restorative Devices
Office of Device Evaluation
Center for Devices and

Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number:

Device Name:

FORTIFY™ Corpectomy Spacers

2112756

Indications:

Prescription Use X (Per 21 CFR §801.109) OR

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)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112756

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.