The distal humerus fracture plates and olecranon fracture plates are indicated for adult patients. The distal humerus and olecranon fracture plates are indicated for fixation of fractures of the humerus and ulna.

Device Description

The Arthrex Elbow Fracture Plating System consists of a series of olecranon and distal humerus plates of varying lengths, thicknesses, and orientations. The proposed plates are contoured and may be available in left and right configurations, ranging from 73 mm to 294.37 mm in length, 1.93 mm to 5.51 mm in thickness, and 10.06 mm to 22 mm in width. Each plate provides locking screw fixation and may include suture holes for soft tissue refixation. The proposed plates are manufactured from stainless steel conforming to ASTM F138 or titanium alloy confirming to ASTM F136 (ISO 5832-3). The plates are sold sterile (Gamma) and non-sterile and are single-use.

AI/ML Overview

The Arthrex Elbow Fracture Plating System is a medical device for fixing fractures of the humerus and ulna in adult patients. The company did not conduct a study with human readers or AI assistance. The study conducted to prove substantial equivalence to a predicate device (K061352: PERI-LOC Periarticular Locked Plating System) was based on engineering and analytical testing, not clinical performance.

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

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Mechanical Performance	Static and Dynamic conditions per ASTM F382-17	"demonstrate that the mechanical performance of the subject device is substantially equivalent to that of the predicate"
Packaging & Shelf-Life	Maintain product and sterility throughout shipping and handling; Meet packaging testing criteria per ISO 11607 and applicable standards.	"The proposed packaging configurations met all the packaging testing acceptance criteria in conformance to ISO 11607 and applicable standards." "The shelf-life of the proposed sterile plates is 5-years."
MRI Safety	MRI force, torque, and image artifact testing per FDA guidance and ASTM standards (F2052, F2119, F2182, F2213)	"MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance... and ASTM standards." (Implied acceptance - labeling for MR Conditional)
Biocompatibility/Sterility	Meet pyrogen limit specifications per ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14.	"The testing conducted demonstrates that the sterile devices meet pyrogen limit specifications."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The documentation does not specify a "test set" in the context of clinical data for performance evaluation. The "tests" performed were engineering and analytical in nature (e.g., Finite Element Analysis, 4-point bend tests, packaging validation, MRI testing, bacterial endotoxin testing). There is no mention of patient data, clinical imagery, or any data provenance related to human subjects.

3. 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. The ground truth for this submission was established through engineering standards, mechanical testing protocols, and laboratory procedures, not through expert clinical consensus or interpretation of patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical test set requiring adjudication.

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. An MRMC comparative effectiveness study was not conducted as this device is a bone plating system, not an AI-assisted diagnostic tool.

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

No. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for demonstrating substantial equivalence for this device was based on:

Established engineering standards (e.g., ASTM F382-17 for mechanical testing, ASTM F2052, F2119, F2182, F2213 for MRI safety).
Regulatory standards (e.g., ISO 11607 for packaging, ANSI/AAMI ST72, USP <161>, USP <85>, EP 2.6.14 for sterilization/pyrogenicity).
Comparison to the predicate device's design, materials, and intended use.

8. The sample size for the training set

Not applicable. There was no "training set" as this device is not an AI/machine learning product.

9. How the ground truth for the training set was established

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

November 14, 2024

Arthrex Inc. Stacy Valdez Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108

Re: K242079

Trade/Device Name: Arthrex Elbow Fracture Plating 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 Dated: October 15, 2024 Received: October 15, 2024

Dear Ms. Valdez:

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.

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"

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(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 OS 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 Rue"). 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-devices/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-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE

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by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali -S

Shumaya Ali, M.P.H. — 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)

K242079

Device Name

Arthrex Elbow Fracture Plating System

Indications for Use (Describe)

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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K242079 Page 1 of 4

510(k) Summary

Date Prepared	11/13/2024
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Name: Stacy ValdezTitle: Principal Regulatory Affairs SpecialistPhone: 1-239-643-5553, ext. 72010Email: stacy.valdez@arthrex.com
Trade Name	Arthrex Elbow Fracture Plating System
Common Name	Plate, Fixation, Bone
Product Code	HRS
Classification Name	21 CFR 888.3030: Single/Multiple Component Metallic BoneFixation Appliances and Accessories
Regulatory Class	II
Predicate Device	K061352: PERI-LOC Periarticular Locked Plating System
Purpose of Submission	This Traditional 510(k) premarket notification is submitted toobtain clearance for the Arthrex Elbow Fracture PlatingSystem.
Device Description	The Arthrex Elbow Fracture Plating System consists of aseries of olecranon and distal humerus plates of varyinglengths, thicknesses, and orientations. The proposed platesare contoured and may be available in left and rightconfigurations, ranging from 73 mm to 294.37 mm in length,1.93 mm to 5.51 mm in thickness, and 10.06 mm to 22 mmin width. Each plate provides locking screw fixation and mayinclude suture holes for soft tissue refixation. The proposedplates are manufactured from stainless steel conforming toASTM F138 or titanium alloy confirming to ASTM F136 (ISO5832-3). The plates are sold sterile (Gamma) and non-sterileand are single-use.
Indications for Use	The distal humerus fracture plates and olecranon fractureplates are indicated for adult patients. The distal humerusand olecranon fracture plates are indicated for fixation offractures of the humerus and ulna.
Performance Data	Arthrex conducted Finite Element Analysis and 4-point bend(ASTM F382-17) under static and dynamic conditions todemonstrate that the mechanical performance of the subjectdevice is substantially equivalent to that of the predicate
Technological Comparison	device PERI-LOC Periarticular Locked Plating System(K061352).
	Arthrex conducted packaging validation and 5-year real-timeaging shelf-life testing to demonstrate that the smaller andlarger packaging configurations are capable of maintainingand protecting the product and sterility of the devicethroughout the shipping and handling environment. Theproposed packaging configurations met all the packagingtesting acceptance criteria in conformance to ISO 11607 andapplicable standards.
	MRI force, torque, and image artifact testing were conductedin accordance with FDA guidance Testing and LabelingMedical Devices for Safety in the Magnetic Resonance (MR)Environment, ASTM F2052 Standard Test Method forMeasurement of Magnetically Induced Displacement Forceon Medical Devices in the Magnetic Resonance Environment.ASTM F2119 Standard Test Method for Evaluation of MRImage Artifacts from Passive Implants, ASTM F2182 StandardTest Method for Measurement of Measurement of RadioFrequency Induced Heating Near Passive Implants DuringMagnetic Resonance Imaging and ASTM F2213 Standard TestMethod for Measurement of Magnetically Induced Torque onMedical Devices in the Magnetic Resonance Environment.
	Bacterial Endotoxins Test (BET) was performed on theArthrex devices utilizing the Kinetic Chromogenic Method inaccordance with ANSI/AAMI ST72:2011/(R)2016, USP <161>,USP <85>, EP 2.6.14. The testing conducted demonstratesthat the sterile devices meet pyrogen limit specifications.
	Assessment of the physical product attributes includingproduct, design, size, and materials has determined that theArthrex Elbow Fracture Plating System does not introduceadditional risks or concerns regarding sterilization and shelf-life.
	The Arthrex Elbow Fracture Plating System is substantiallyequivalent to the predicate devices cleared under thepredicate device PERI-LOC Periarticular Plating System(K061352) in which basic design features, intended use,
fundamental scientific technology, materials, plate configuration, and sterility are identical.
Indications for Use:
• The indications for use for the distal humerus fracture plates and olecranon fracture plates are equivalent to the predicate device PERI-LOC Periarticular Locked Plating System (K061352) except for the following:
Ο The distal humerus fracture plates and olecranon fracture plates will be indicated for a subset of anatomical locations and will not include a pediatric patient population or osteopenic bone compared to predicate device PERI-LOC Periarticular Locked Plating System (K061352).
The Arthrex Elbow Fracture Plating System will be offered in shorter and longer lengths than the predicate device PERI-LOC Periarticular Plating System (K061352).
The Arthrex Elbow Fracture Plating System will be offered in a smaller and larger width than the predicate device PERI-LOC Periarticular Plating System (K061352).
The Arthrex Elbow Fracture Plating System is offered in smaller and larger thickness than the predicate device PERI-LOC Periarticular Plating System (K061352).
Packaging:
• The non-sterile plates are packaged inside a Polyethylene Bag inside an inner Zip Lock Polyethylene Bag or a single Polyethylene bag. The proposed non-sterile plates are also packaged in a single Polypropylene tube.
• The sterile plates are packaged in a double PETG blister tray with Tyvek lidding or a double Nylon/Nylon pouch.
Shelf-Life:
	The shelf-life of the proposed sterile plates is 5-years. The Arthrex Elbow Fracture Plating System was evaluated forMR Conditional labeling. The predicate devices cleared underthe predicate device PERI-LOC Periarticular Plating System(K061352) were not evaluated for MR Conditional labeling.The Arthrex Elbow Fracture Plating System is substantiallyequivalent to the predicate device PERI-LOC PeriarticularPlating System (K061352) with the same intended use andminor differences in design and function. Any differencesbetween the Arthrex Elbow Fracture Plating System and thepredicate device are considered minor and do not raisedifferent questions of safety or effectiveness.
Conclusion	The Arthrex Elbow Fracture Plating System is substantiallyequivalent to the predicate devices cleared under K061352 inwhich the basic design features and intended use are thesame. Any differences between the Arthrex Elbow FracturePlating System and the predicate device are consideredminor and do not raise different questions of safety orBased on the indications for use, technologicalcharacteristics, and the summary of data submitted, ArthrexInc. has determined that the proposed device is substantiallyequivalent to the currently marketed predicate device.

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K242079 Page 4 of 4

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.