The XTEND™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

Device Description

The XTEND™ Anterior Cervical Plate System consists of standard plates, Extender plates and Universal Extender plates. Extender plates may be used for revision surgery in which additional stabilization is required. Extender plates are attached to an adjacent XTEND™ plate, and Universal Extender plates are inserted adjacent to other plates. XTEND™ plates are available in various lengths to be used with either variable angle screws or fixed angle screws. Each XTEND™ plate is attached to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). The XTEND™ Anterior Cervical Plate System implants are composed of titanium allov, as specified in ASTM F136 and F1295.

AI/ML Overview

The provided text is a 510(k) summary for the XTEND™ Anterior Cervical Plate System. This document focuses on demonstrating substantial equivalence to previously approved devices through engineering and mechanical testing, rather than clinical studies involving human or animal subjects or AI/algorithm performance. Therefore, many of the requested categories are not applicable to this type of regulatory submission.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the XTEND™ Anterior Cervical Plate System are based on mechanical testing in accordance with FDA guidance. The "reported device performance" is the successful meeting of these criteria, which is implied by the 510(k) clearance.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from Guidance)	Reported Device Performance
Mechanical Testing	Must meet relevant ASTM standards (e.g., F136 for titanium alloy, F1295 for titanium alloy) and FDA "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. This typically includes:	The device successfully met the mechanical testing requirements to demonstrate substantial equivalence to predicate devices.
	- Static Compression Bending Test	Met applicable loads/displacements.
	- Dynamic Compression Bending (Fatigue) Test	Met applicable cycles/loads without failure.
	- Static Torsion Test	Met applicable loads/displacements.
	- Pull-out Strength (Screw-bone interface simulation)	Met applicable forces.
Biocompatibility	Materials must be biocompatible (ASTM F136 and F1295 for titanium alloy).	Materials (Titanium Alloy) are well-established as biocompatible for implantable devices.
Design Characteristics	Similar design features and operating principles to predicate devices.	The device's design is stated to be similar, with modifications like Extender plates.
Material Characteristics	Composed of specified medical-grade materials.	Composed of titanium alloy (ASTM F136 and F1295).
Intended Use	Match or be a subset of the predicate device's intended use.	Intended use matches or is a subset of predicate devices.

The Study that Proves the Device Meets the Acceptance Criteria:

The submission 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."

This indicates that a series of in vitro mechanical tests were conducted on the XTEND™ Anterior Cervical Plate System. The purpose of these tests was to demonstrate that the device's performance characteristics (e.g., strength, durability, fatigue resistance) are equivalent to or better than those of the predicate devices. By meeting the benchmarks established in the FDA guidance and through comparison with predicate devices, the XTEND™ system was deemed substantially equivalent.

Non-Applicable Categories based on the provided text:

The following information is not present in the provided 510(k) summary because this type of premarket submission for a spinal implant device typically relies on engineering and material equivalence, rather than clinical trial data or AI performance metrics.

Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. This refers to test samples for mechanical testing, not patient data. No human or animal data is detailed.
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. "Ground truth" is not established by human experts in the context of mechanical testing for substantial equivalence.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is a physical spinal implant, not an AI diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical spinal implant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance is established by standardized mechanical testing protocols and material specifications, as well as the performance of predicate devices.
The sample size for the training set: Not applicable. There is no "training set" in the context of a 510(k) submission for a physical implant.
How the ground truth for the training set was established: Not applicable.

Summary

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K092146

NOV 1 6 2009

510(K) Summary: XTEND™ Anterior Cervical Plate 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:	XTEND™ Anterior Cervical Plate System
Classification:	Per 21 CFR as follows:§888.3060 Spinal Intervertebral Body Fixation OrthosisProduct Code KWQ.Regulatory Class II, Panel Code 87.
Predicate(s):	VIP® K081391 (SE date July 3, 2008)ASSURE® K040721 (SE date June 17, 2004)PROVIDENCE® K070775 (SE date April 19, 2007)

Device Description:

Intended Use:

Basis of Substantial Equivalence:

XTEND™ Anterior Cervical Plate System is similar to the predicate systems 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Globus Medical. Inc. % Kelly J. Baker, Ph.D. 2560 General Armistead Avenue, Valley Forge Audubon, Pennsylvania 19403

NOV 1 6 2009

Re: K092146

Trade/Device Name: XTEND Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: November 10, 2009 Received: November 12, 2009

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 incications 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 Foond, Or to 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 misburoni, in and adulteration.

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 dovine 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 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.

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Page 2 - Kelly J. Baker. Ph.D.

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 fou 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely vours.

Mark A. Millmann

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

Kog 2146 510(k) Number:

XTEND™ Anterior Cervical Plate System Device Name:

INDICATIONS:

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)

Mark A. Milliken

(Division Sign-Off) (Division Sign-gical, Orthopedic, and Restorative Devices

510(k) Number K092144

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.