The Humeral Plating System is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

The Cerclage Button is intended for use with the humeral plating system and FiberTape® cerclage suture, to augment fracture stabilization with humeral plates in long bone fixation. The cerclage button is designed for use with the humeral plating system and may not be used alone.

Device Description

The Arthrex Humeral Plating and Cerclage Button consist of straight humeral plates and a 3.5 threaded cerclage button for use in the repair of proximal humerus fractures. The devices are provided sterile (gamma) and non-sterile, for single use. The proposed plates range in length from 90.5 - 309 mm and include suture holes for soft tissue refixation. The proposed devices are manufactured from titanium alloy conforming to ASTM F136. The proposed devices are compatible with Arthrex 3.5 mm screws (K241592 and K203294) and Arthrex 4.0 mm screws (K150456, K143614, and K103705).

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets those criteria, as typically found in submissions for AI/ML-based medical devices. The document describes a traditional 510(k) premarket notification for a Class II metallic bone fixation appliance (Arthrex Humeral Plating System and Cerclage Button).

The "Performance Data" section mentions mechanical testing (4-point bend, MRI compatibility) and bacterial endotoxin testing, which are standard for orthopedic implants to demonstrate engineering performance and biocompatibility compared to predicate devices. However, this is not a study proving an AI/ML device meets clinical acceptance criteria.

Therefore, I cannot extract the information required to populate the fields you listed, such as sample size, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the type of device described in this document.

Summary

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March 26, 2025

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Arthrex Inc. Ivette Galmez Principal Regulatory Affairs Specialist 1370 Creekside Blvd. Naples, Florida 34108

Re: K243995

Trade/Device Name: Arthrex Humeral Plating System and Cerclage Button Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, JDQ Dated: December 23, 2024 Received: December 26, 2024

Dear Ivette Galmez:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

CHRISTOPHER FERREIRA -S

Christopher Ferreira, M.S. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices 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

Submission Number (if known)

K243995

Device Name

Arthrex Humeral Plating System and Cerclage Button

Indications for Use (Describe)

The Humeral Plating System is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

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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K243995 510(k) Summary

Date Prepared	12/23/2024
Submitter	Arthrex Inc.
	1370 Creekside Boulevard
	Naples, FL 34108-1945
Contact Person	Name: Ivette Galmez
	Title: Principal Regulatory Affairs Specialist
	Phone: 239-643-5553, ext. 71263
	Email: Ivette.galmez@arthrex.com
Trade Name	Arthrex Humeral Plating System and Cerclage Button
Common Name	Plate, Fixation, Bone
	Cerclage, Fixation
Product Code	HRS, JDQ
Classification Name	21 CFR 888.3030: Single/Multiple Component Metallic Bone Fixation
	Appliances and Accessories
	21 CFR 888.3010: Bone fixation cerclage
Regulatory Class	II
Primary Predicate Device	K180310: Depuy Synthes LCP Proximal Humerus Plate
Additional Predicate	K172975: Depuy Synthes Cerclage Positioning Pin
Reference Devices	K242079: Arthrex Elbow Fracture Plating System
Purpose of Submission	This Traditional 510(k) premarket notification is submitted to obtain clearance
	for the Arthrex Humeral Plating System and Cerclage Button.
Device Description	The Arthrex Humeral Plating and Cerclage Button consist of straight humeral
	plates and a 3.5 threaded cerclage button for use in the repair of proximal
	humerus fractures. The devices are provided sterile (gamma) and non-sterile,
	for single use. The proposed plates range in length from 90.5 - 309 mm and
	include suture holes for soft tissue refixation. The proposed devices are
	manufactured from titanium alloy conforming to ASTM F136. The proposed
	devices are compatible with Arthrex 3.5 mm screws (K241592 and K203294)and Arthrex 4.0 mm screws (K150456, K143614, and K103705).

Indications for Use	The Arthrex Humeral Plating System is indicated for fractures and fracture
	dislocations, osteotomies, and non-unions of the proximal humerus,
	particularly in osteopenic bone.
	The Cerclage Button is intended for use with the humeral plating system andFiberTape® cerclage suture, to augment fracture stabilization with humeral
	plates in long bone fixation. The cerclage button is designed for use with the
	humeral plating system and may not be used alone.
Performance Data	Arthrex conducted 4-point bend (ASTM F382-17) testing to demonstrate that
	the Arthrex Humeral Plating System perform statistically equivalent to theprimary predicate device Depuy-Synthes LCP Plates (K180310).MRI force, torque, and image artifact testing were conducted in accordancewith FDA guidance Testing and Labeling Medical Devices for Safety in theMagnetic Resonance (MR) Environment, ASTM F2052 Standard Test Methodfor Measurement of Magnetically Induced Displacement Force on MedicalDevices in the Magnetic Resonance Environment, ASTM F2119 Standard Test
	Method for Evaluation of MR Image Artifacts from Passive Implants, ASTMF2182 Standard Test Method for Measurement of Measurement of RadioFrequency Induced Heating Near Passive Implants During Magnetic ResonanceImaging and ASTM F2213 Standard Test Method for Measurement ofMagnetically Induced Torque on Medical Devices in the Magnetic ResonanceEnvironment.Bacterial Endotoxins Test (BET) was performed on the Arthrex devices utilizingthe Kinetic Chromogenic Method in accordance with ANSI/AAMIST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14. The testing conducteddemonstrates that the sterile devices meet pyrogen limit specifications.Assessment of the physical product attributes including product, design, size,and materials has determined that the Arthrex Humeral Plating System andCerclage Button do not introduce additional risks or concerns regardingsterilization and shelf-life.
TechnologicalComparison	The main differences with the predicates are provided below:• The indications for use for the proposed Cerclage Button are equivalent tothe Depuy-Synthes Cerclage Positioning Pin (K172975), except that theindications for the proposed device have been updated to indicate that thecerclage button is an adjunct device for use only with the proposed ArthrexHumeral Plating System, and to include the recommended Arthrex suturefor use.• The proposed humeral plates are manufactured from a titanium alloy thatis a different from the predicate humeral plates (K180310).• The proposed humeral plates will be offered in lengths outside thepredicate humeral plates (K180310) size range.
Conclusion	The Arthrex Humeral Plating System and Cerclage Button is substantiallyequivalent to the primary Depuy Synthes LCP Proximal Humerus Plate(K180310) and Depuy Synthes Cerclage Positioning Pin (K172975) in which thebasic design features and intended use are the same. The proposed deviceshave the same fundamental scientific technology, and are made withequivalent materials, design configuration, and sterility availability. Anydifferences between the Arthrex Humeral Plating System and Cerclage Button,and the predicate devices are considered minor and do not raise differentquestions of safety or effectiveness.Based on the indications for use, technological characteristics, and thesummary of data submitted, Arthrex Inc. has determined that the proposeddevices are substantially equivalent to the currently marketed predicatedevices.

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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.