FORTIFY™ Integrated Corpectomy Spacers (FORTIFY™ I and FORTIFY™ I-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). 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™ Intearated 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 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™ Integrated endplates have an integrated plate to accommodate screws for additional fixation, and are assembled to the core.

FORTIFY™ and FORTIFY™ I Corpectomy Spacers are manufactured from titanium alloy per ASTM F136 and F1295. FORTIFY™-R and FORTIFY™ I-R Corpectomy Spacers are manufactured from radiolucent PEEK OPTIMA LT1, with titanium alloy and tantalum components, per ASTM F2026, F136, F1295, and F560. Screws are manufactured from titanium alloy per ASTM F136 and F1295, with or without hydroxvapatite coating per ASTM F1185.

AI/ML Overview

The provided text is for a 510(k) premarket notification for a medical device (FORTIFY™ I Corpectomy Spacers). This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving that the device meets specific, pre-defined acceptance criteria through a clinical study with a specified ground truth and expert adjudication. The information requested in your prompt (e.g., sample size for test/training sets, number/qualifications of experts, adjudication methods, MRMC study results, standalone performance, ground truth types) is typically associated with clinical trials or AI/software validation studies, which are not directly presented in this 510(k) summary.

Therefore, many of the requested fields cannot be filled directly from the provided text.

Here's an attempt to extract what is available and explain what is missing:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Not explicitly stated as criteria, but implied by regulatory guidance)	Reported Device Performance (as demonstrated by mechanical testing)
Mechanical integrity comparable to predicate devices in:	Static compression, dynamic compression, static torsion, dynamic torsion, expulsion, and screw pushout tests were conducted. The devices demonstrated substantial equivalence to the predicate system(s) in these mechanical properties.
Compliance with relevant ASTM standards:	Testing was conducted in accordance with ASTM F2077 and "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004.
Material specifications:	Manufactured from titanium alloy per ASTM F136 and F1295 (FORTIFY™ and FORTIFY™ I). Radiolucent PEEK OPTIMA LT1 with titanium alloy and tantalum components per ASTM F2026, F136, F1295, and F560 (FORTIFY™-R and FORTIFY™ I-R). Screws from titanium alloy per ASTM F136 and F1295, with or without Hydroxyapatite coating per ASTM F1185.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable/Not provided. This document describes mechanical testing, not a clinical study with a patient test set. The "samples" would refer to the number of devices tested mechanically, but this specific number is not disclosed.
Data Provenance: Not applicable/Not provided in the context of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This submission focuses on mechanical performance and substantial equivalence to predicate devices, not on diagnostic accuracy requiring expert interpretation or ground truth establishment in a clinical setting.

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

Not applicable. No clinical test set or adjudication process is described.

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. An MRMC comparative effectiveness study was not performed. This is a 510(k) for a physical medical implant, not an AI or imaging device that would typically involve such studies.

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

Not applicable. This is not an algorithm or AI device.

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

Mechanical Testing Standards: The "ground truth" in this context is the performance specified by recognized consensus standards (e.g., ASTM F2077) for spinal intervertebral body fixation orthosis devices, and the comparative performance of the predicate devices. The device's mechanical properties were evaluated against these benchmarks.

8. The sample size for the training set

Not applicable. There is no "training set" for this type of mechanical device evaluation.

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

Not applicable. There is no "training set" for this type of mechanical device evaluation.

Summary of what can be inferred:

The FORTIFY™ I Corpectomy Spacers aim to achieve substantial equivalence to predicate devices (FORTIFY™ Corpectomy Spacers (K112756) and Ulrich AddPlus™ (K090841)). The primary "study" proving this equivalence involved mechanical testing (static & dynamic compression, static & dynamic torsion, expulsion, and screw pushout). This testing was conducted in accordance with established FDA guidance ("Guidance for Spinal System 510(k)s") and ASTM F2077, which serve as the "acceptance criteria" and "ground truth" for mechanical performance in this context. The document does not provide details on the number of devices tested (sample size) for these mechanical evaluations, nor does it involve clinical data, human experts, or AI algorithms.

Summary

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JUL 3 2012 510(k) Summary: FORTIFY™ I Corpectomy Spacers

Company:	Globus Medical Inc.
	2560 General Armistead Ave.
	Audubon, PA 19403
	(610) 930-1800
Contact:	Sarah Marie Fitzgerald
	Project Manager, Regulatory Affair

Date Prepared: May 31, 2012

Device Name: FORTIFY Integrated Corpectomy Spacers (FORTIFY™ I and FORTIFY™ I-R)
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.

Predicate(s): FORTIFY™ Corpectomy Spacers (K112756) Ulrich AddPlus™ (K090841)

Purpose:

The purpose of this submission is to request clearance for the FORTIFY Integrated Corpectomy Spacers.

Device Description:

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Indications for Use:

Performance Data:

Mechanical testing (static & dynamic compression, static & dynamic torsion, expulsion, and screw pushout) 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™ Integrated 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, with three wave-like lines below the eagle.

Public Health Service

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

. JUL 3 2012

Globus Medical, Inc. % Ms. Sarah Marie Fitzgerald Project Manager, Regulatory Affairs 2560 General Armistead Ave. Audobon, Pennsylvania 19403

Re: K121107

Trade/Device Name: FORTIFY Integrated Corpectomy Spacers (FORTIFY I and FORTIFY I-R) Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: June 4, 2012 Received: June 5, 2012

Dear Ms. Fitzgerald:

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.

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Page 2- Ms. Sarah Marie Fitzgerald

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Millam

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

K121107 510(k) Number:

FORTIFY™ Integrated Corpectomy Spacers Device Name:

Indications:

Prescription Use × (Per 21 CFR §801.109) Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

OR .

Concurrence of CDRH, Office of Device Evaluation (ODE)

Diysion Sign-Off) Dission of Surgical, Orthopedic, and Restorative Devices

KI21107 510(k) Number_

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.