The ANTHEM™ Fracture System is indicated for fixation of fractures, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, fibula, ankle, and foot. The clavicle hook plate may be used for dislocations of the acromioclavicular joint.

Small fragment, proximal tibia, clavicle and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius plates may be used in adolescents (12-21 years of age). Plating may be used in patients with osteopenic bone.

Device Description

The ANTHEM™ Fracture System is a family of plates and screws designed to be used for internal bone fixation. The implants are available in various sizes and shapes to accommodate patient anatomy, and may be contoured or straight, sterile and non-sterile, with locking and non-locking screws. ANTHEM™ implants are manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F1472, F1537, F2229, F138 and F139. All implants are for single use only.

AI/ML Overview

Here's an analysis of the provided FDA 510(k) summary regarding the ANTHEM™ Fracture System, focusing on acceptance criteria and supporting studies.

General Observation: The provided document is for a medical device (bone fixation system), not a diagnostic algorithm or AI product. Therefore, the typical "acceptance criteria" related to diagnostic performance (sensitivity, specificity, AUC) and associated studies (MRMC, standalone) are not applicable in this context. The acceptance criteria here would be related to mechanical performance, material properties, and biological safety, demonstrating substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Mechanical Performance	ASTM F543 (Standard Specification for Metallic Medical Bone Screws)	Performance of ANTHEM™ Fracture System plates and screws was evaluated in accordance with ASTM F543.
Mechanical Performance	ASTM F382 (Standard Specification for Metallic Bone Plates)	Performance of ANTHEM™ Fracture System plates and screws was evaluated in accordance with ASTM F382.
Material Composition	ASTM F136 (Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications)	Implants manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136.
Material Composition	ASTM F1295 (Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications)	Implants manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F1295.
Material Composition	ASTM F1472 (Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications)	Implants manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F1472.
Material Composition	ASTM F1537 (Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539))	Implants manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F1537.
Material Composition	ASTM F2229 (Standard Specification for Wrought, Nitrogen Strengthened 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel Bar, Billet, and Wire for Surgical Implants (UNS S21727))	Implants manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F2229.
Material Composition	ASTM F138 (Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673))	Implants manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F138.
Material Composition	ASTM F139 (Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet, Strip, and Plate for Surgical Implants (UNS S31673))	Implants manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F139.
Manufacturing/Usage	Single Use Only	All implants are for single use only.
Substantial Equivalence	Technological characteristics (design, intended use, material composition, size range)	ANTHEM™ implants have the same technological characteristics as the predicate devices.
Substantial Equivalence	Performance	Performance demonstrated through engineering analysis and compliance with standards.
Substantial Equivalence	Intended Use	(Implied by overall claim of substantial equivalence and stated Indications for Use)

Study Proving Device Meets Acceptance Criteria:

The primary study type used to demonstrate that the device meets acceptance criteria and is substantially equivalent is non-clinical performance testing and engineering analysis.

Performance Data: "Performance of the ANTHEM™ Fracture System plates and screws was evaluated in accordance with ASTM F543 and ASTM F382. An engineering analysis was conducted for the plates and screws to demonstrate substantial equivalence to the predicate devices." (Page 4)

This indicates that mechanical tests were performed according to specified ASTM standards for bone screws and plates. The "engineering analysis" would involve comparing the design, materials, and expected performance of the new device to the predicate devices.

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

Sample Size: The document does not explicitly state a "sample size" in terms of number of devices tested. For mechanical testing, this typically refers to a specified number of samples (e.g., 5, 10, or more) of each device configuration required by the ASTM standard to be tested to demonstrate compliance. This information is usually detailed in the full test report, not summarized in the 510(k) statement.
Data Provenance: Not applicable in the context of this type of medical device submission. The tests are laboratory-based mechanical and material property evaluations, not clinical data.

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

Not Applicable: This submission is for a physical medical device (bone fixation system), not a diagnostic algorithm. Therefore, "ground truth" established by human experts in the diagnostic sense (e.g., radiologists interpreting images) is not relevant here. Ground truth in this context would be defined by the physical dimensions, material properties, and mechanical performance test results as measured by calibrated equipment according to standard protocols.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not Applicable: Adjudication methods like 2+1 are used in clinical studies where human interpretation of data (e.g., imaging) needs to be reconciled to establish a consensus ground truth. This is not relevant for the mechanical testing of a bone fixation device.

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

Not Applicable: The device is a physical bone fixation system, not an AI diagnostic tool.

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

Not Applicable: The device is a physical bone fixation system, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Technical Ground Truth: For this device, the "ground truth" and acceptance criteria are derived from:
- Mechanical Standards: Adherence to established ASTM standards (F543 for screws, F382 for plates) for mechanical properties (e.g., strength, fatigue resistance).
- Material Standards: Adherence to established ASTM standards for medical-grade materials (e.g., F136 for titanium alloy, F1537 for cobalt chromium molybdenum alloy, F138/F139/F2229 for stainless steel).
- Dimensional Specifications: Compliance with design specifications and tolerances that match predicate devices.
  The "truth" is objective, measurable, and defined by engineering and material science principles, not clinical outcomes or expert interpretation of patient data.

8. The Sample Size for the Training Set

Not Applicable: This is not a machine learning or AI device. There is no "training set" in the context of establishing substantial equivalence for a physical medical device. Device design and manufacturing processes are developed based on engineering principles and predicate device characteristics, not through data training.

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

Not Applicable: As there is no "training set," this question is not relevant.

Summary

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November 13, 2017

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

Re: K173166

Trade/Device Name: ANTHEM™ Fracture System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: September 28, 2017 Received: September 29, 2017

Dear Kelly 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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,

Mark N. Melkerson -S

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

510(k) Number (if known) K173166

Device Name ANTHEM™ Fracture System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 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) (Signature)

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510(k) Summary: ANTHEM™ Fracture System

Company: Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 610-930-1800
Contact: Kelly J. Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs
Date Prepared: September 28, 2017
Device Name: ANTHEM™ Fracture System
Common Name: Bone plate & screws
Classification: Per 21 CFR as follows: §888.3030 Single/multiple component metallic bone fixation appliance and accessories §888.3040 Smooth or threaded metallic bone fixation fastener Product Code: HRS, HWC Regulatory Class: II
Primary Predicate: ANTHEM™ Fracture System (K163361)

Additional

Predicates: Clavicle Plates

Synthes 2.7/3.5mm VA-LCP Anterior Clavicle Plates (K101536) Synthes 3.5mm LCP Clavicle Plates (K111540) Synthes 2.7/3.5mm VA-LCP Anterior Clavicle Plates (K101536) Synthes Clavicle Hook Plates (K061753) Acumed Congruent Bone Plates (K012655) Stryker VariAx Clavicle Plates (K130116) Stryker VariAx Clavicle Hook Plates (K140259) Orthopediatrics PediLoc Locking Plate System (K083286)

Proximal Tibial Plates Smith & Nephew PERI-LOC VLP Proximal Tibia Plates (K071563) Smith & Nephew PERI-LOC Periarticular Locked Plates (K092015) Stryker AxSOS 3 Ti Locking Plates (K133440)

Purpose:

The purpose of this submission is to request clearance of ANTHEM™ Clavicle Plates, ANTHEM™ Proximal Tibial Plates and line extensions to cleared ANTHEM™ Plates.

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Device Description:

Indications for Use:

The ANTHEM™ Fracture System is indicated for fixation of fractures, osteotomies, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, femur, tibia, fibula, ankle, and foot. The clavicle hook plate may be used for dislocations of the acromioclavicular joint.

Performance Data:

Performance of the ANTHEM™ Fracture System plates and screws was evaluated in accordance with ASTM F543 and ASTM F382. An engineering analysis was conducted for the plates and screws to demonstrate substantial equivalence to the predicate devices.

Technoloqical Characteristics:

ANTHEM™ implants have the same technological characteristics as the predicate devices including design, intended use, material composition, and range of sizes.

Basis of Substantial Equivalence:

The subject ANTHEM™ Fracture System has been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided supports substantial equivalence to the predicate devices.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.