When used as a vertebral body replacement device in the cervical spine (C2-T1), COLOSSEUM™M Mesh devices 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 as a vertebral body replacement device in the thoracolumbar spine (T1-L5), COLOSSEUM™ Mesh devices are intended for use to replace a collapsed, 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 vertebral body replacement device 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, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

Device Description

COLOSSEUM™ Mesh are devices that can be used as vertebral body replacement devices. The components of the implant include a preformed mesh cage and optional endcaps, which are available in a range of sizes and options to accommodate various surgical approaches and the anatomical needs of a wide variety of patients. The mesh and the endcaps are intraoperatively assembled to best fit individual requirements. Protrusions (teeth) on the superior and inferior surfaces of the endcaps grip the endplate of the adjacent vertebrae to resist expulsion.

COLOSSEUM™ Mesh implants are used to provide structural stability and as an adjunct to fusion in skeletally mature individuals following corpectomy or vertebrectomy in the cervical and thoracolumbar spine. Thoracolumbar mesh implants may be inserted using a posterior, transforaminal, anterior, anterolateral, or lateral approach. Cervical mesh implants are inserted using an anterior approach.

COLOSSEUM™ Mesh implants are manufactured from titanium alloy as specified in ASTM F136. All implants are single use only.

AI/ML Overview

This document describes a spinal implant device, COLOSSEUM™ Mesh, and its clearance process through the FDA's 510(k) pathway. This pathway demonstrates substantial equivalence to legally marketed predicate devices, rather than requiring a device to meet specific acceptance criteria through a clinical study or a detailed performance study with a defined test set, ground truth independent validation.

Therefore, many of the requested details, such as the sample size for a test set, the number of experts used to establish ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set information are not applicable to this type of device submission. The FDA 510(k) process for this device focuses on demonstrating that it is as safe and effective as a legally marketed predicate device, primarily through mechanical testing and material characterization, rather than through a clinical performance study with a test set and ground truth in the way one would evaluate an AI/ML or diagnostic device.

Here's a breakdown of the requested information based on the provided document:

1. A table of Acceptance Criteria and the Reported Device Performance:

Since this is a 510(k) submission for a spinal implant, the "acceptance criteria" are not reported as specific performance metrics like sensitivity/specificity for a diagnostic device. Instead, the acceptance criteria are adherence to recognized standards and demonstration of substantial equivalence to predicate devices. The "reported device performance" refers to the successful completion of these tests.

Acceptance Criteria (based on 510(k) requirements and listed standards)	Reported Device Performance
Mechanical Testing:	Successfully completed:
- Static Compression (ASTM F2077)	Devices demonstrated performance comparable to predicate devices.
- Dynamic Compression (ASTM F2077)	Devices demonstrated performance comparable to predicate devices.
- Static Torsion (ASTM F2267)	Devices demonstrated performance comparable to predicate devices.
- Dynamic Torsion (ASTM F2267)	Devices demonstrated performance comparable to predicate devices.
- Expulsion (Guidance for Spinal System 510(k)s)	Devices demonstrated performance comparable to predicate devices.
- Subsidence (Guidance for Spinal System 510(k)s)	Devices demonstrated performance comparable to predicate devices.
MRI Compatibility Testing:	Successfully completed:
- Magnetically Induced Displacement Force (ASTM F2052)	Tested and found acceptable.
- MR Image Artifacts (ASTM F2119)	Tested and found acceptable.
- Radio Frequency Induced Heating (ASTM F2182)	Tested and found acceptable.
- Magnetically Induced Torque (ASTM F2213)	Tested and found acceptable.
Biocompatibility Testing:	Successfully completed:
- Bacterial Endotoxin (ANSI/AAMI ST-72)	Complied with standards.
- Patient-contacting materials adherence to standards or prior 510(k) clearance	Materials met applicable standards or were used in previously 510(k) cleared devices, demonstrating biocompatibility.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective), (If applicable to a clinical study):

Not Applicable. This submission details mechanical and material testing, not a clinical study on human subjects with a test set of clinical data (like images or patient records). The "samples" here are physical devices subjected to laboratory tests.

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), (If applicable to a clinical study):

Not Applicable. Ground truth, in the context of this device, refers to established engineering standards (ASTM, ANSI/AAMI) for mechanical properties and material safety. Expert consensus in a clinical diagnostic sense is not involved in establishing the "ground truth" for these engineering tests.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set, (If applicable to a clinical study):

Not Applicable. No human adjudication of clinical "ground truth" was performed as part of this submission. The "adjudication" is performed by satisfying the requirements of the specified engineering standards.

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 (If applicable):

Not Applicable. COLOSSEUM™ Mesh is a physical implant, not an AI or diagnostic imaging device. Therefore, no MRMC study was conducted or is relevant.

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

Not Applicable. COLOSSEUM™ Mesh is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.), (If applicable to a clinical study):

Engineered/Standardized Ground Truth. The "ground truth" for this device's performance is defined by established engineering and material standards (e.g., ASTM F2077 specifies how compression strength is measured, and success is defined by meeting certain load requirements or demonstrating equivalence to predicate devices). It's not clinical data, but rather mechanical and material properties verified in a lab setting.

8. The sample size for the training set (If applicable to an AI/ML device):

Not Applicable. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set."

9. How the ground truth for the training set was established (If applicable to an AI/ML device):

Not Applicable. This is a physical medical device, not an AI/ML algorithm.

Summary

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May 8, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K190147

Trade/Device Name: COLOSSEUM™ Mesh Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP, PLR Dated: May 1, 2019 Received: May 2, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about medical devices and radiation-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,

for CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190147

Device Name COLOSSEUM™ Mesh

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)

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510(k) Summary: COLOSSEUM™ Mesh

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
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Contact: Kelly J. Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs
May 1, 2019 Date Prepared:
Device Name: COLOSSEUM™ Mesh
Common Name: Spinal intervertebral fixation orthosis
Classification: Per 21 CFR as follows: §888.3060 Spinal Intervertebral Fixation Orthosis Product Code(s): MQP, PLR Regulatory Class II, Panel Code 87

Primary Predicate: FORTIFY® Corpectomy Spacers (K162315)

Additional

Predicates: FORTIFY® Corpectomy Spacers (K112756, K173982) Synthes SynMesh (K041389)

Purpose:

The purpose of this submission is to request clearance for COLOSSEUM™ Mesh.

Device Description:

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COLOSSEUM™ Mesh implants are manufactured from titanium alloy as specified in ASTM F136. All implants are single use only.

Indications for Use:

When used as a vertebral body replacement device in the cervical spine (C2-T1), COLOSSEUM™ Mesh devices 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 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 as a vertebral body replacement device in the thoracolumbar spine (T1-L5), COLOSSEUM™ Mesh 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 vertebral body replacement device 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 FDAcleared 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, static and dynamic torsion, expulsion, and subsidence) was conducted in accordance with ASTM F2077, ASTM F2267, expulsion, and "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. Performance data demonstrate substantial equivalence to the predicate devices.

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

ASTM F2052:2015 Standard Test Method for Measurement of 0 Magnetically Induced Displacement Force on Medical Devices in the Maqnetic 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

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ASTM F2213:2017 Standard Test Method for Measurement of . Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011. Biocompatibility of patient-contacting materials was demonstrated by using materials that meet applicable standards or are used in 510(k) cleared devices.

Technological Characteristics:

Subject COLOSSEUM™ Mesh implants have similar technological characteristics as the predicate devices including design, intended use, material composition, function, and range of sizes.

Basis of Substantial Equivalence:

The subject COLOSSEUM™ Mesh implants have been found to be substantially equivalent 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 implants to the predicate device.

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.