The PROTEX® CT Occipito-Cervico-Thoracic Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft, for stabilization of the cervical spine and occipito-cervico-thoracic iunction (occiput-T3) for the following conditions: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors.

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Occipital bone screws are limited to occipital fixation; they are not intended for fixation of the posterior cervical spine. The 3.2mm rod implants are for use in the cervical and upper thoracic spine and are not intended for occipital fixation.

The PROTEX® CT Occipito-Cervico-Thoracic Spinal System 3.7mm rods can also be linked to rod systems ranging in diameter from 3.7mm to 6.5mm, including the PROTEX® or REVERE® System, using corresponding parallel connectors.

Device Description

The PROTEX™ CT Occipito-Cervico-Thoracic Spinal System consists of 3.2mm and 3.7mm rods, polyaxial screws, hooks, locking caps, t-connectors, lateral connectors, parallel connectors, and occipital clamps. The implants are composed of titanium alloy (per ASTM F136, F1472, or F1295), or stainless steel (per ASTM F138).

Due to the risk of galvanic corrosion following implantation, titanium alloy implants should not be connected to stainless steel implants.

AI/ML Overview

The provided document describes a 510(k) summary for the PROTEX® CT Occipito-Cervico-Thoracic Spinal System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies with acceptance criteria for device performance. Therefore, many of the requested details, such as sample sizes for test sets, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment for AI/algorithm-based devices, are not applicable to this type of regulatory submission for a spinal system.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion Type	Acceptance Criteria	Reported Device Performance
Substantial Equivalence	The device (PROTEX® CT Occipito-Cervico-Thoracic Spinal System) must be substantially equivalent to a legally marketed predicate device (Globus Medical PROTEX® CT Cervicothoracic Spinal System, K050391) with respect to technical characteristics, performance, and intended use. This is demonstrated through mechanical testing and comparison of design features and materials.	The submission states that "The PROTEX® CT additional implants are similar to the predicate PROTEX® CT implants with respect to technical characteristics, performance, and intended use. Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 is presented." The FDA concluded the device is substantially equivalent.
Material Composition	Implants composed of titanium alloy (per ASTM F136, F1472, or F1295), or stainless steel (per ASTM F138). Must explicitly state that titanium alloy implants should not be connected to stainless steel implants due to galvanic corrosion risk.	The device components are made from "titanium alloy (per ASTM F136, F1472, or F1295), or stainless steel (per ASTM F138)." The warning about galvanic corrosion is explicitly stated.
Intended Use Scope	Intended for stabilization of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for specific conditions (degenerative disc disease, spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors). Specific limitations on component placement (polyaxial screws in T1-T3, occipital bone screws for occipital fixation only, 3.2mm rods for cervical/upper thoracic spine only, not occipital).	The stated "Indications for Use Statement" precisely matches these criteria, including all specific conditions and component placement limitations.
Rod Interconnectivity	3.7mm rods can be linked to rod systems ranging from 3.7mm to 6.5mm (e.g., PROTEX® or REVERE® System) using corresponding parallel connectors.	The "Indications for Use Statement" confirms this capability.

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

This information is not applicable in the context of this 510(k) submission. This is a request for regulatory clearance for a physical medical device (spinal system), not an AI/algorithm-based diagnostic or imaging device. The "test set" here refers to the parameters and conditions used during mechanical testing, not a dataset of patient images or clinical outcomes. The document explicitly states "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 is presented." The details of this mechanical testing (e.g., number of cycles, loads, etc.) would be in the full submission but are not summarized for a "test set" in the way an AI study would present it.

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

Not applicable. As this is a spinal implant, "ground truth" would relate to mechanical properties, biocompatibility, and manufacturing quality, not expert interpretation of clinical data in the context of AI. Mechanical performance is typically verified by engineering standards and testing, not expert consensus on a test set.

4. Adjudication Method for the Test Set

Not applicable. See point 3. Adjudication methods are relevant for subjective interpretations, often in clinical imaging or diagnostics.

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, a MRMC study was not done. This type of study is specific to AI or imaging devices where human interpretation is involved. This submission is for a physical orthopedic implant.

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

Not applicable. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

For this device, the "ground truth" for demonstrating safety and effectiveness for a 510(k) submission of a spinal system primarily relies on:

Mechanical Testing Results: Demonstrating the device meets established engineering standards for strength, fatigue, and other biomechanical properties.
Material Specifications: Adherence to ASTM standards for titanium alloy and stainless steel.
Predicate Device Comparison: Showing that the new device's design, materials, and intended use are substantially equivalent to a previously cleared device, indicating a similar safety and efficacy profile.
Compliance with Guidance Documents: Following FDA's specific guidance for spinal system 510(k)s.

8. The Sample Size for the Training Set

Not applicable. This device is a physical implant, not an AI model requiring a training set.

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

Not applicable. See point 8.

Summary

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NOV 1 4 2008

510(K) Summary: PROTEX® CT Occipito-Cervico-Thoracic Spinal System

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403(610) 415-9000
Contact:	Kelly J. Baker, Ph.DDirector, Clinical Affairs & Regulatory
Device Name:	PROTEX® CT Occipito-Cervico-Thoracic Spinal System
Classification:	Per 21 CFR as follows:§888.3050 Spinal Interlaminal Fixation OrthosisProduct Code KWP.Regulatory Class II, Panel Code 87.
Predicate(s):	Globus Medical PROTEX® CT Cervicothoracic Spinal SystemK050391, SE date February 15, 2005Product Code KWP and MNIRegulatory Class II, Panel Code 87.

Device Description:

Due to the risk of galvanic corrosion following implantation, titanium alloy implants should not be connected to stainless steel implants.

Intended Use:

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K081906

Page 2 of 2

implants are for use in the cervical and upper thoracic spine and are not intended for occipital fixation.

Basis of Substantial Equivalence:

The PROTEX® CT additional implants are similar to the predicate PROTEX® CT implants with respect to technical characteristics, performance, and intended use. Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 is presented.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation. The overall design is simple yet recognizable, representing the department's role in public health and human services.

NOV 1 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K081906

Trade/Device Name: PROTEX® CT Occipito-Cervico-Thoracic Spinal System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis. Regulatory Class: II Product Code: KWP Dated: October 14, 2008 Received: October 15, 2008

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 - Kelly J. Baker, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincercly yours,

Mark of Milker

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

Indications for Use Statement

510(k) Number:

K081906

Device Name:

PROTEX® CT Occipito-Cervico-Thoracic Spinal System

INDICATIONS:

The PROTEX® CT Occipito-Cervico-Thoracic Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft, for stabilization of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following conditions: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors.

The PROTEX® CT Occipito-Cervico-Thoracic Spinal System 3.7mm rods can also be linked to rod systems ranging in diameter from 3.7mm to 6.5mm,
including the PROTEX® or REVERE® System, using corresponding parallel connectors.

Prescription Use × (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 of General. Restorative. and Neurological Devices

510(k) Number K081506

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.