The Arthrex Fracture Plates are intended to be used for internal bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibula.

The Arthrex Low Profile Screws (2.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Distal Extremity Plates, Humeral Fracture Plates, and Osteotomy Plates.

The Arthrex Low Profile Screws (3.5mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula.

Device Description

The proposed Arthrex Ankle Fracture System consists of a series of plates and screws of varying lengths and orientations for versatile treatment of distal tibia fractures. The Ankle Fracture System Plates consist of posterior and vertical plates that are anatomically contoured to provide fixation in the talus and may be available in left and right configurations. Each plate provides locking screw fixation. The proposed Arthrex Low Profile Screws are a family of fully threaded, solid, non-locking or locking screws; and partially threaded, cannulated and non-locking screws. The proposed plates and screws are manufactured from Titanium Alloy. The proposed plates and screws are sold sterile (Gamma) and non-sterile and are single-use.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for the Arthrex Ankle Fracture System. It focuses on demonstrating substantial equivalence to a predicate device, primarily through mechanical testing and comparison of technological characteristics.

Crucially, this document does not describe a study involving an AI/software medical device. Therefore, most of the requested information regarding AI performance criteria, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for training/test sets is not applicable to this submission.

The "Performance Data" section explicitly states the types of tests performed:

Mechanical Testing: Pull-out (ASTM F543-17), Failure Torque, Insertion Torque (ASTM F543-17), and 4-Point Bend (ASTM F382-17). These tests compare the mechanical performance of the new device to predicate devices.
MRI Compatibility Testing: MRI force, torque, and image artifact testing based on FDA guidance and ASTM standards (F2052, F2119, F2182, F2213).
Sterility Testing: Bacterial Endotoxins Test (BET) in accordance with ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the acceptance criterion for mechanical testing was to demonstrate that the Arthrex Ankle Fracture System performs "statistically equivalent" to the predicate devices. Specific numerical acceptance criteria (e.g., minimum pull-out strength in Newtons) are not provided in this summary document, but rather implied by the statistical equivalence claim. Similarly, for MRI compatibility and sterility, the acceptance criterion is compliance with the specified ASTM/USP standards.

Acceptance Criterion Type	Acceptance Criterion (as described)	Reported Device Performance (as described)
Mechanical Performance	Statistically equivalent to predicate devices K123241, K103705, and K143614 for: Pull-out, Failure Torque, Insertion Torque (ASTM F543-17), and 4-Point Bend (ASTM F382-17).	The Arthrex Ankle Fracture System performs "statistically equivalent to the predicate devices cleared under K123241, K103705 and K143614." The submitted data "demonstrates that the Pull-out, 4-Point Bend strength and Failure Torque/Insertion Torque... is substantially equivalent to that of the predicate devices."
MRI Compatibility	Compliant with FDA guidance and specified ASTM standards (F2052, F2119, F2182, F2213) for force, torque, and image artifacts.	MRI force, torque, and image artifact testing were conducted in accordance with the specified FDA guidance and ASTM standards. The device was evaluated for MR Conditional labeling.
Sterility / Pyrogenicity	Meet pyrogen limit specifications per ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14 using Kinetic Chromogenic Method.	Testing "demonstrates that the sterile devices... meet pyrogen limit specifications."
Physical Attributes	Not introduce additional risks or concerns regarding sterilization and shelf-life compared to predicates.	Assessment determined that the system "does not introduce additional risks or concerns regarding sterilization and shelf-life."

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

Sample Size: The document does not specify the specific number of physical samples (e.g., plates, screws) tested for each mechanical or MRI test. Typically, these tests involve a statistically relevant number of samples to generate the reported data, but the exact number is not disclosed in this summary.
Data Provenance: The data is generated from in vitro laboratory testing of the physical device components (plates and screws). This is not retrospective or prospective patient data from a specific country of origin, but rather engineering test data derived from manufactured devices.

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

Not Applicable. This submission is for a physical medical device (bone fixation system), not an AI/software device that requires expert review of medical images or data to establish ground truth. The "ground truth" for this device's performance is derived from standardized physical and mechanical tests.

4. Adjudication Method for the Test Set

Not Applicable. As this is not an AI/software device involving subjective interpretations (like image readings), there is no need for expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is relevant to AI/software devices that assist human readers (e.g., radiologists) in diagnostic tasks. For a bone fixation system, an MRMC study is not applicable.

6. Standalone (Algorithm Only Without Human-in-the Loop) Performance Study

Not Applicable. There is no AI algorithm being evaluated. The device's performance is its physical properties.

7. The Type of Ground Truth Used

Engineering Test Results / Standardized Measurements: The ground truth for this device's performance is established through measurable physical properties (e.g., pull-out force, bending strength, torque) obtained from well-defined and standardized laboratory tests (ASTM, USP, ANSI/AAMI standards). Comparison is made against predicate devices' measured performance.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/software device that requires a "training set" of data for machine learning.

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

Not Applicable. As there is no training set for an AI model, this question is not relevant.

Summary

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May 2, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an abstract design. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.

Arthrex Inc. Stacy Valdez Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K213837

Trade/Device Name: Arthrex Ankle 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: December 7, 2021 Received: December 9, 2021

Dear Stacy 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 (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 located 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.

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

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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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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 by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

510(k) Number (if known)

K213837

Device Name Arthrex Fracture Plates

Indications for Use (Describe)

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

Research Use (Part 21 CFR 601 Subpart D)	Compassionate Use (21 CFR 601 Subpart E)
-------------------------------------------------------------------	-------------------------------------------------------------------

× | Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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Indications for Use

510(k) Number (if known)

K213837

Device Name Arthrex Low Profile Screws

Indications for Use (Describe)

The Arthrex Low Profile Screws (2.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humers, radius, ulna, tibia, calcaneous, femur, and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Distal Extremity Plates, Humeral Fracture Plates, and Osteotomy Plates.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

Date Prepared	February 04, 2022
Submitter	Arthrex Inc.
	1370 Creekside Boulevard
	Naples, FL 34108-1945
Contact Person	Stacy Valdez
	Senior Regulatory Affairs Specialist
	1-239-643-5553, ext. 72010
	Stacy.valdez@arthrex.com
Name of Device	Arthrex Ankle Fracture System
Common Name	Plate, fixation, bone
Product Code	HRS (Primary), HWC
Classification Name	21 CFR 888.3030: Single/multiple component metallic bone fixation appliances
	and accessories (Primary)
	21 CFR 888.3040: Smooth or threaded metallic bone fastener
Regulatory Class	II
Primary Predicate	K123241: Arthrex Fracture Plates
Reference Devices	K151732: Arthrex Fracture Plates
	K203294: Arthrex Pilon Fusion System
Purpose of	This Traditional 510(k) premarket notification is submitted to obtain clearance for
Submission	the Arthrex Ankle Fracture System.
Device Description	The proposed Arthrex Ankle Fracture System consists of a series of plates and
	screws of varying lengths and orientations for versatile treatment of distal tibia
	fractures. The Ankle Fracture System Plates consist of posterior and vertical
	plates that are anatomically contoured to provide fixation in the talus and may be
	available in left and right configurations. Each plate provides locking screw
	fixation. The proposed Arthrex Low Profile Screws are a family of fully threaded,
	solid, non-locking or locking screws; and partially threaded, cannulated and non-
	locking screws. The proposed plates and screws are manufactured from Titanium
	Alloy. The proposed plates and screws are sold sterile (Gamma) and non-sterile
	and are single-use.

Indications for Use	The Arthrex Fracture Plates are intended to be used for internal bone fixation for
	bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand,wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, fibula.

	The Arthrex Low Profile Screws (2.5mm and larger, solid) are intended to be used
	as stand-alone bone screws, or in a plate-screw system for internal bone fixation
	for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand,
	wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous,
	femur, and fibula. When used with a plate, the screws may be used with the
	Arthrex Low Profile, Small Fragment Plates, Fracture Plates, Distal Extremity
	Plates, Humeral Fracture Plates, and Osteotomy Plates.

	The Arthrex Low Profile Screws (3.5mm and larger, cannulated) are intended to
	be used as stand-alone bone screws for internal bone fixation for bone fractures,
	fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle,
	scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula.
Performance Data	Arthrex conducted Pull-out (ASTM F543-17), Failure Torque, Insertion Torque
	(ASTM F543-17) and 4-Point Bend (ASTM F382-17) testing to demonstrate that

	the Arthrex Ankle Fracture System performs statistically equivalent to thepredicate devices cleared under K123241, K103705 and K143614.
	MRI force, torque, and image artifact testing were conducted in accordance withFDA guidance Testing and Labeling Medical Devices for Safety in the MagneticResonance (MR) Environment, ASTM F2052 Standard Test Method forMeasurement of Magnetically Induced Displacement Force on Medical Devices inthe Magnetic Resonance Environment, ASTM F2119 Standard Test Method forEvaluation of MR Image Artifacts from Passive Implants, ASTM F2182 StandardTest Method for Measurement of Measurement of Radio Frequency InducedHeating Near Passive Implants During Magnetic Resonance Imaging and ASTMF2213 Standard Test Method for Measurement of Magnetically Induced Torqueon Medical Devices in the Magnetic Resonance Environment.
	Arthrex Plates and Screws are tested for Bacterial Endotoxins Test (BET) 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 within the Arthrex Plates and Screws meetpyrogen limit specifications.
	Assessment of physical product attributes including product, design, size, andmaterials has determined that the Arthrex Ankle Fracture System does notintroduce additional risks or concerns regarding sterilization and shelf-life.
TechnologicalComparison	The Arthrex Ankle Fracture System is substantially equivalent to the predicatedevices cleared under K123241 in which the basic design features,intended use, fundamental scientific technology, materials (screws only), shelf-life, and sterility are identical.
	The Arthrex Ankle Fracture System Plates are manufactured from Titanium AlloyTi-6AL-4V conforming to ASTM F136. The primary predicate plates cleared underthe Arthrex Fracture Plates, K123241 are manufactured from CP Grade 4Titanium conforming to ASTM F67. The proposed Arthrex Ankle Fracture Systemplates are offered in widths ranging from 8 mm to 10/21.1 mm. The primarypredicate plates cleared under the Arthrex Fracture Plates, K123241 are offeredin widths ranging from 9 - 13/35 mm.
	The sterile Arthrex Ankle Fracture System Plates are packaged in a doublePolyethylene/Tyvek pouch or a double Nylon/Nylon pouch. The non-sterileArthrex Ankle Fracture System plates are packaged inside a Polyethylene Bagwithin an inner Zip-Lock Polyethylene Bag, a Double Polyethylene Bag, or a SinglePolyethylene Bag. The primary predicate plates cleared under Arthrex FracturePlates, K123241 are packaged in a polyethylene pouch.
	The sterile Arthrex Ankle Fracture System screws are packaged in a PETG BlisterTray with a Tyvek Lidding or a double Polyethylene/Tyvek pouch. The non-sterileArthrex Ankle Fracture System screws are packaged inside a Polyethylene Bagwithin an inner Zip-Lock Polyethylene Bag or a Single Polyethylene Bag. Theprimary predicate screws cleared under Arthrex Fracture Plates, K123241 arepackaged in a polyethylene pouch.
	The Arthrex Ankle Fracture System was evaluated for MR Conditional labeling aswere the predicate devices cleared under K203294 and K210994.
	The Arthrex Ankle Fracture System is substantially equivalent to the predicatedevices cleared under K123241, with minor modifications with no change tointended use or function. Any differences between the Arthrex Ankle FractureSystem and the predicate devices are considered minor and do not raise differentquestions of safety or effectiveness.
Conclusion	The Arthrex Ankle Fracture System is substantially equivalent to the predicatedevices cleared under K123241 in which the basic design features and intendeduse are the same. Any differences between the Arthrex Ankle Fracture Systemand the predicate devices are considered minor and do not raise differentquestions of safety or effectiveness.
	The submitted mechanical testing data demonstrates that the Pull-out, 4-PointBend strength and Failure Torque/Insertion Torque of the Arthrex Ankle FractureSystem is substantially equivalent to that of the predicate devices for the desiredindications.
	Based on the indications for use, technological characteristics, and the summaryof data submitted, Arthrex Inc. has determined that the proposed device issubstantially equivalent to the currently marketed predicate devices.

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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.