The UNIFY® Dynamic Anterior Cervical Plate System and the ASSURE® Anterior Cervical Plate System are 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 (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

Device Description

The UNIFY® Dynamic and ASSURE® Anterior Cervical Plate Systems consist of plates and variable or fixed angle screws. The plates attach to the anterior portion of the vertebral body of the cervical spine (C2-C7). The UNIFY® plates allow translation to accommodate bone graft resorption. The UNIFY® additional implants are manufactured from titanium alloy, as specified in ASTM standards F136, F1295 and F1472.

AI/ML Overview

This K133567 510(k) submission describes the UNIFY® Dynamic and ASSURE® Anterior Cervical Plate Systems, specifically requesting clearance for additional UNIFY® screws to be used with ASSURE® and UNIFY® plates, and the use of ASSURE® rigid screws with the UNIFY® plate.

The study presented to establish substantial equivalence is a mechanical testing study.

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

1. Table of Acceptance Criteria and Reported Device Performance

This device is a physical medical implant, not an AI/software device. Therefore, the "acceptance criteria" are related to mechanical performance, and the "reported device performance" reflects how the implants fared in these tests compared to predicate devices.

Acceptance Criteria (Performance Measure)	Reported Device Performance (UNIFY® / ASSURE®)
Mechanical equivalence to predicate devices for specific screw/plate combinations (as assessed by engineering analysis of design, materials, and dimensions).	The technological characteristics of the UNIFY® additional implants are "similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics."
Static cantilever bending strength in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s, May 3, 2004."	Performance data demonstrates "substantial equivalence to the predicate devices."
Screw push-out strength in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s, May 3, 2004."	Performance data demonstrates "substantial equivalence to the predicate devices."

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

Sample Size: The document does not specify the exact number of samples (e.g., number of screws, plates, or test permutations) used for the mechanical testing. It broadly states "Mechanical testing... was conducted."
Data Provenance: The study was conducted as mechanical testing/engineering analysis. Therefore, provenance would relate to the testing facility and methodology rather than patient data. The document does not specify the location of the testing. The data is prospective, in the sense that the tests were specifically performed for this submission.

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 mechanical engineering study, not an AI/software study involving clinical image interpretation or diagnosis by experts. The "ground truth" is defined by established engineering standards and physical properties.

4. Adjudication Method for the Test Set

Not applicable for a mechanical engineering study. Performance is assessed against defined physical and mechanical standards, not through expert adjudication of ambiguous cases.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant to evaluate the impact of AI on human reader performance, typically in diagnostic imaging. This submission deals with the mechanical performance of a spinal implant.

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. It's a physical medical implant.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on established engineering principles, ASTM standards (F136, F1295, F1472), and FDA guidance documents ("Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s, May 3, 2004"). The performance of the new implants is compared to the known and accepted performance characteristics of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

Summary

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510(k) Summary: UNIFY® Dynamic and ASSURE® Anterior Cervical Plate Systems

Company:	Globus Medical Inc.Valley Forge Business Center2560 General Armistead AvenueAudubon, PA 19403(610) 930-1800
Contact:	Christina KichulaGroup Manager, Regulatory Affairs
Date Prepared:	November 19, 2013
Device Name:	UNIFY® Dynamic Anterior Cervical Plate SystemASSURE® Anterior Cervical Plate System
Classification:	Per 21 CFR as follows:§888.3060: Spinal Intervertebral Body Fixation OrthosisProduct Code: KWQRegulatory Class II, Panel Code 87.
Predicate(s):	UNIFY® Dynamic Anterior Cervical Plate System (K121049)ASSURE® Anterior Cervical Plate System (K040721)

Purpose:

The purpose of this submission is to request clearance for additional UNIFY® screws to be used with ASSURE® and UNIFY® plates and use of ASSURE® rigid screws with the UNIFY® plate.

Device Description:

The UNIFY® additional implants are manufactured from titanium alloy, as specified in ASTM standards F136, F1295 and F1472.

Indications for Use:

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deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

Technological Characteristics:

The technological characteristics of the UNIFY® additional implants are similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics.

Performance Data:

Mechanical testing (engineering analysis and static cantilever bending and screw push-out) was conducted in accordance with the 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.

Basis of Substantial Equivalence:

UNIFY® additional implants are similar to the predicate devices with respect to technical characteristics, material, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices. UNIFY® additional implants perform as well as or better than the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem of an eagle with outstretched wings, stylized with three thick lines forming the body and wings.

Public I lealth Service

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

February 20, 2014

Globus Medical, Incorporated Ms. Christina Kichula Group Manager, Regulatory Affairs 2560 General Armistead Ave. Audubon, PA 19403 US

Re: K133567

Trade/Device Name: UNIFY® Dynamic Anterior Cervical Plate System. ASSURE® Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 29, 2014 Received: January 30, 2014

Dear Ms. Kichula:

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 nanufacturing 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Christina Kichula

forth in the quality systems (OS) 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

Vincență@evlin -5

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date. December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K133567

Device Name

UNIFY® Dynamic Anterior Cervical Plate System

Indications for Use (Describe)

The UNIFY® Dynamic Anterior Cervical Plate System is intended for anterior servical spine (C2-C7) for the follawing indications: degenerative disc disease tus discogenic origin with degeneration of the disc confirmed by natient history and rediographic studies), traumn (including fractures), tumors, deformity (kyphosis, lordosis or scollosis), pseudarthrosis. failed previous fusions. spondylolisthesis, and spinal stenosis.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY HILL BE REAL BE REAL POLICE .

Concurrence of Center for Devices and Radiological Health (CDRK) (Signature)

Image /page/4/Picture/15 description: The image shows the text "Anton E. Dmitriev, PhD" in bold, with a line underneath. Below this, the text "Division of Orthopedic Devices" is displayed in a larger, bold font. The text is arranged to convey a sense of professional or organizational information, possibly indicating a person's name, title, and the division they belong to.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K133567

Device Name

ASSURE® Anterior Cervical Plate System

Indications for Use (Describe)

The ASSURE® Anterior Cervical Plate System is interior screw fixation to the cervicel spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with disc confirmed by patient history and radiographic studies), trauna (including fractures), tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions. spondylolisthesis, and spinal stenosis.

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)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

Image /page/5/Picture/15 description: The image shows the text "Anton E. Dmitriev, PhD" in bold font with a line underneath. Below this text is the text "Division of Orthopedic Devices" in a smaller, non-bold font. The text is black against a white background.

FORM FDA 3881 (9/13)

Portider: Son and hollid 14.14.14.14.12.180 FT

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.