The Arthrex 2.4 mm Volar Distal Radius Plate System is internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius and distal ulna. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for palmar, dorsal, or orthogonal application.

The Arthrex Low Profile Screws (2.4 mm 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, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile, Small Fragment Plates, Distal Extremity Plates, and Distal Radius Plates.

Device Description

The Arthrex 2.4 mm Volar Distal Radius Plate System consists of a series of plates and screws of varying lengths and orientations. The Arthrex 2.4 mm Volar Distal Radius Plates are 2.26 mm in thickness. Each plate provides locking screw fixation. The proposed plates are manufactured from CP Grade 4 Titanium conforming to ASTM F67. The plates are sold as sterile (Gamma), single-use, and non-sterile, single-use.

The Arthrex Low Profile Screws are a family of fully threaded, solid, non-locking screws. The screw family is offered in 2.4 mm in diameter and range in lengths from 6 mm to 40 mm. The screws are manufactured from Titanium Alloy conforming to ASTM F136. The screws are sold sterile (Gamma) and are single-use.

AI/ML Overview

The provided text describes the Arthrex 2.4 mm Volar Distal Radius Plate System and Arthrex Low Profile Screws. It outlines the device's intended use and performance data as part of a 510(k) premarket notification.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily demonstrated through substantial equivalence to predicate devices and adherence to relevant ASTM and AAMI standards.

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Mechanical Performance	4-Point Bend (ASTM F382-17): Statistically equivalent performance to predicate devices and reference devices.	Arthrex 2.4 mm Volar Distal Radius Plate System plates perform statistically equivalent to the additional predicate devices cleared under Arthrex Plates, Screws and Staples, K150456, which were originally cleared under primary predicate Arthrex Distal Radius Plate System, K131474.
MRI Safety	FDA guidance: Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213: Evaluation for MR Conditional labeling.	MRI force, torque, and image artifact testing were conducted in accordance with these standards. The device was evaluated for MR Conditional labeling. (The text does not explicitly state the quantitative results or confirm "MR Conditional" status, only that it was evaluated for it.) The primary predicate (K131474) was not evaluated for MR Safety.
Biocompatibility/Sterility	Bacterial Endotoxins Test (BET): Kinetic Chromogenic Method in accordance with ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14. Must meet pyrogen limit specifications.	Testing demonstrates that the sterile devices within the Arthrex Plates meet pyrogen limit specifications.
Material Composition	Plates: CP Grade 4 Titanium conforming to ASTM F67. Screws: Titanium Alloy conforming to ASTM F136.	Plates are manufactured from CP Grade 4 Titanium conforming to ASTM F67. Screws are manufactured from Titanium Alloy conforming to ASTM F136. This is stated as equivalent to the primary predicate K131474.
Physical Dimensions	Plates: 2.26 mm thickness. Screws: 2.4 mm diameter.	Plates are 2.26 mm in thickness. Screws are 2.4 mm in diameter. This is stated as equivalent to the primary predicate K131474.
Shelf-life	Non-sterile plates: Unlimited shelf-life (equivalent to predicate). Sterile plates/screws: Labeled with a 5-year shelf-life.	Non-sterile Arthrex 2.4 mm Volar Distal Radius Plates have an unlimited shelf-life. Sterile Arthrex 2.4 mm Volar Distal Radius Plates and Arthrex Low Profile Screws are labeled with a 5-year shelf-life.

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

Sample Size for Test Set: Not explicitly stated. The document mentions "testing" (e.g., 4-Point Bend testing, MRI testing, BET) but does not provide specific sample quantities for each test.
Data Provenance: Not explicitly stated. Given it's a 510(k) submission for a medical device designed for fracture fixation, the testing would typically be conducted under controlled laboratory conditions rather than involving human patient data at this stage. It's safe to assume the testing is prospective and controlled in nature.

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

This information is not provided in the given text. The studies described are primarily mechanical, material, and safety tests rather than clinical studies requiring expert interpretation of results to establish ground truth. The "ground truth" for these tests are the objective measurements against established standards.

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are laboratory-based performance and safety tests, not clinical evaluations requiring adjudication of subjective outcomes.

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

This is not applicable. The device described is a physical implant (plate and screws) for internal bone fixation, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness is discussed.

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

This is not applicable as the device is a physical implant, not an algorithm or software.

7. The Type of Ground Truth Used

The ground truth used for the reported studies is based on objective measurements and adherence to established industry standards (ASTM, AAMI, USP, EP) and FDA guidance for device performance, material properties, and safety (e.g., strength, dimensions, pyrogen limits, MRI compatibility).

8. The Sample Size for the Training Set

This is not applicable as the device is a physical implant, not a machine learning model requiring a training set.

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

This is not applicable for the same reason as above.

Summary

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October 3, 2022

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

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

Re: K222267

Trade/Device Name: Arthrex 2.4 mm Volar Distal Radius Plate 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: July 23, 2022 Received: July 28, 2022

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 (QS) 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K22267

Device Name

Arthrex 2.4 mm Volar Distal Radius Plate Sytem

Indications for Use (Describe)

The Arthrex 2.4 mm Volar Distal Radius Plate System is internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius and distal ulna. Examples of these internal fixations and reconstructions include compression fractures, intra-articular fractures, displaced fractures. osteotomies, non-unions and malunions. This system can be used for palmar, dorsal or orthogonal application.

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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Indications for Use

510(k) Number (if known) K22267

Device Name Arthrex Low Profile Screws

Indications for Use (Describe)

The Arthrex Low Profile Screws (2.4 mm, 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, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile, Small Fragment Plates, Distal Extremity Plates, and Distal Radius Plates.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CER 801 Subpart D)	Over-The-Counter Use (21 CER 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	September 26, 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 2.4 mm Volar Distal Radius Plate System
Common Name	Plate, fixation, boneScrew, fixation, bone
Product Code	HRS, HWC
Classification Name	21 CFR 888.3030: Single/multiple component metallic bone fixationappliances and accessories (Primary)
	21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener
Regulatory Class	II
Predicate Device	K131474: Arthrex Distal Radius Plate System
Additional Predicate Device(s)	K150456: Arthrex Plates, Screws and Staples
Reference Device(s)	K203294: Arthrex Pilon Fusion SystemK213837: Arthrex Ankle Fracture System
Purpose of Submission	This Traditional 510(k) premarket notification is submitted to obtainclearance for the Arthrex 2.4 mm Volar Distal Radius Plate System.
Device Description	The Arthrex 2.4 mm Volar Distal Radius Plate System consists of a seriesof plates and screws of varying lengths and orientations. The Arthrex 2.4mm Volar Distal Radius Plates are 2.26 mm in thickness. Each plateprovides locking screw fixation. The proposed plates are manufacturedfrom CP Grade 4 Titanium conforming to ASTM F67. The plates are soldas sterile (Gamma), single-use, and non-sterile, single-use.
	The Arthrex Low Profile Screws are a family of fully threaded, solid, non-locking screws. The screw family is offered in 2.4 mm in diameter andrange in lengths from 6 mm to 40 mm. The screws are manufacturedfrom Titanium Alloy conforming to ASTM F136. The screws are soldsterile (Gamma) and are single-use.
Indications for Use	The Arthrex 2.4 mm Volar Distal Radius Plate System is intended forinternal fixation for fractures and reconstruction of the small bones,primarily including the distal radius and distal ulna. Examples of theseinternal fixations and reconstructions include compression fractures,intra-articular and extra-articular fractures, displaced fractures,osteotomies, non-unions and mal-unions. This system can be used forpalmar, dorsal, or orthogonal application.
	The Arthrex Low Profile Screws (2.4 mm solid) are intended to be usedas stand-alone bone screws, or in a plate-screw system for internal bonefixation for bone fractures, fusions, osteotomies and non-unions in theankle, foot, hand, and wrist. When used with a plate, the screw may beused with the Arthrex Low Profile, Small Fragment Plates, DistalExtremity Plates, and Distal Radius Plates.
Performance Data	Arthrex conducted 4-Point Bend (ASTM F382-17) testing to demonstrate
	that the Arthrex 2.4 mm Volar Distal Radius Plate System plates perform statistically equivalent to the additional predicate devices cleared under Arthrex Plates, Screws and Staples, K150456. The devices cleared under the additional predicate Arthrex Plates, Screws and Staples, K150456 were originally cleared under primary predicate Arthrex Distal Radius Plate System, K131474.
	MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants, ASTM F2182 Standard Test Method for Measurement of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging and ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.
	Bacterial Endotoxins Test (BET) was performed on the Arthrex 2.4 mm Volar Distal Radius Plate System utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14. The testing conducted demonstrates that the sterile devices within the Arthrex Plates meet pyrogen limit specifications.
Technological Comparison	The Arthrex 2.4 mm Volar Distal Radius Plate System is substantially equivalent to the predicate devices cleared under K131474 in which the basic design features, intended use, fundamental scientific technology, materials, shelf-life (non-sterile only), and sterility (non-sterile only) are identical.
	The Arthrex 2.4 mm Volar Distal Radius Plates are manufactured from CP Grade 4 Titanium conforming to ASTM F67 which is equivalent to the primary predicate Arthrex Distal Radius Plate System, K131474. The Arthrex 2.4 mm Volar Distal Radius Plates are 2.26 mm in thickness which is equivalent to the primary predicate Arthrex Distal Radius Plate System.
	The Arthrex Low Profile Screws are manufactured from Titanium conforming to ASTM F136 which is equivalent to the primary predicate Arthrex Distal Radius Plate System, K131474. The Arthrex Low Profile Screws are 2.4 mm in diameter which is equivalent to the primary predicate Arthrex Distal Radius Plate System, K131474.
	The Arthrex 2.4 mm Volar Distal Radius Plates are provided non-sterile which is equivalent to the primary predicate Arthrex Distal Radius Plate System, K131474. The Arthrex 2.4 mm Volar Distal Radius Plates are also provided sterile (Gamma). The Arthrex Low Profile Screws are provided sterile (Gamma).
	The non-sterile Arthrex 2.4 mm Volar Distal Radius Plates have an

	unlimited shelf-life which is equivalent to the primary predicate ArthrexDistal Radius Plate System, K131474. The sterile Arthrex 2.4 mm VolarDistal Radius Plates and Arthrex Low Profile Screws are labeled with a 5-year shelf-life.
	The Arthrex 2.4 mm Volar Distal Radius Plate System was evaluated forMR Conditional labeling. The primary predicate Arthrex Distal RadiusPlate System, K131474 was not evaluated for MR Safety.
	The Arthrex 2.4 mm Volar Distal Radius Plate System is substantiallyequivalent to the predicate devices cleared under K131474, with minormodifications with no change to intended use or function. Anydifferences between the Arthrex 2.4 mm Volar Distal Radius PlateSystem and the predicate devices are considered minor and do not raisedifferent questions of safety or effectiveness.
Conclusion	The Arthrex 2.4 mm Volar Distal Radius Plate System is substantiallyequivalent to the predicate devices cleared under K131474 in which thebasic design features and intended use are the same. Any differencesbetween the Arthrex 2.4 mm Volar Distal Radius Plate System and thepredicate devices are considered minor and do not raise differentquestions of safety or effectiveness.
	The submitted mechanical testing data demonstrates that the 4-PointBend strength of the Arthrex 2.4 mm Volar Distal Radius Plates aresubstantially equivalent to that of the predicate devices for the desiredindications.
	Based on the indications for use, technological characteristics, and thesummary of data submitted, Arthrex Inc. has determined that theproposed device is substantially equivalent to the currently marketedpredicate 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.