The Arthrex DualCompression Hindfoot Fusion Nail Implant System is intended to facilitate tibiotalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after turnor resection. These include neuroosteoarthropathy (Charcot's Foot), avascular necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, osteoarthritis, rheumatoid arthritis, and pseudoarthrosis.

Device Description

The Arthrex DualCompression Hindfoot Fusion Nail Implant System is comprised of the Arthrex DualCompression Hindfoot Fusion Nails, Interlocking Screws, Cable and End Caps. The Arthrex DualCompression Hindfoot Nail is available in 10.5, 11.5 and 12.5 mm diameters and lengths of 180, 210, 240 and 300 mm. The Interlocking Screws are fully threaded, headed or headless, self-tapping, solid, low profile screws. The screw family is 5.0 mm in diameter and ranges from 20 mm to 120 mm in length (in 2 or 5 mm increments). The End Caps are designed to prevent bone in growth in the distal portion of the Nail implant for ease of removal. The end cap family ranges from 1 to 11 mm in length for various countersinking depths.

The Arthrex DualCompression Hindfoot Fusion Nails are manufactured from Titanium Alloy (Ti-6AL-4V conforming to ASTM F136), Superelastic Nitinol (conforming to ASTM F2063) and Polyetheretherketone (PEEK)(conforming to ASTM F2026). The Arthrex DualCompression Hindfoot Nail is sold sterile and is single-use. The Interlocking Screws and End Caps are manufactured from Titanium Alloy (Ti-6AL-4V conforming to ASTM F136). The Interlocking Screws and End Caps are sold non-sterile and are single-use.

AI/ML Overview

This is a 510(k) summary for a medical device called the "Arthrex DualCompression Hindfoot Fusion Nail Implant System." It is not a study that demonstrates the performance of an AI/ML powered device. Therefore, I cannot provide the detailed information requested regarding acceptance criteria, study design, and ground truth establishment for such a device.

However, I can extract information related to the performance data and the comparison made for this specific device in its 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a traditional 510(k) for a hardware implant, the "acceptance criteria" are based on demonstrating substantial equivalence to existing predicate devices. Performance is assessed through mechanical and biocompatibility testing, not through clinical accuracy metrics for AI. The table below summarizes the types of tests performed and the general conclusion regarding equivalence. Specific numerical acceptance criteria values are not provided in this summary, but the conclusion states that the device performs "equivalent to the predicate devices" or meets "pyrogen limit specifications."

Acceptance Criteria Category	Reported Device Performance
Mechanical Performance
Static four-point bend	Substantially equivalent to predicate devices (K090857)
Static torque	Substantially equivalent to predicate devices (K090857)
Dynamic compression bending fatigue	Substantially equivalent to predicate devices (K090857)
Fatigue strength	Substantially equivalent to predicate devices (K090857)
Static and dynamic 3-point bend (ASTM F1264-16e1)	Substantially equivalent to predicate devices (K090857)
Axial pull-out	Substantially equivalent to predicate devices (K090857)
Maximum torque (ASTM F543-17)	Acceptable (engineering analysis)
Breaking angle (ASTM F543-17)	Acceptable (engineering analysis)
Insertion, Driving, Removal Torque	Acceptable (engineering analysis)
Material/Biocompatibility
Corrosion resistance (ASTM F2129)	Testing was conducted
Fretting corrosion (ASTM F1875, ASTM F897)	Testing was conducted
Bend and free recovery (ASTM F2082/F2082M)	Testing was conducted
In-vitro fretting corrosion (ASTM F1875)	Study was conducted
Ion release (ASTM F3306)	Study was conducted
Cytotoxicity	Testing was conducted (ISO 10993-1:2018)
Sensitization	Testing was conducted (ISO 10993-1:2018)
Irritation	Testing was conducted (ISO 10993-1:2018)
Genotoxicity	Testing was conducted (ISO 10993-1:2018)
Systemic Toxicity	Testing was conducted (ISO 10993-1:2018)
Subchronic/Subacute Toxicity	Testing was conducted (ISO 10993-1:2018)
Implantation	Testing was conducted (ISO 10993-1:2018)
Material Characterization	Testing was conducted (ISO 10993-1:2018)
Sterilization/Shelf-life
Bacterial Endotoxins Test (BET) (Kinetic Chromogenic Method, ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14)	Meets pyrogen limit specifications
Physical product attributes (product, design, size, materials)	Does not introduce additional risks or concerns regarding sterilization and shelf-life
MRI Safety
MRI force, torque, and image artifact testing (FDA guidance, ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213)	Evaluated for MR Conditional labeling

2. Sample size used for the test set and the data provenance:

Test Set (for mechanical & physical testing): The document does not specify the exact number of samples (test articles) used for each mechanical, material, or biocompatibility test. It only states that "testing was conducted."
Data Provenance: The tests are laboratory-based and conducted in accordance with recognized ASTM and ISO standards. The data provenance is these standardized laboratory test environments. It is not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. For a hardware implant, "ground truth" typically refers to established physical properties and biological responses, measured in a laboratory setting or specified by standards. It does not involve expert interpretation of medical images or clinical outcomes in the same way an AI device would.

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

This is not applicable for the type of testing described (mechanical, material, biocompatibility). Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical studies, particularly for AI devices where human expert consensus is needed.

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. No MRMC comparative effectiveness study was performed as this is a hardware implant, not an AI-powered diagnostic or assistive tool.

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.

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

The "ground truth" for this device's evaluation is primarily established by:

Standardized Test Methods: Adherence to established ASTM and ISO standards (e.g., for mechanical properties, biocompatibility, and MRI safety).
Engineering Analyses: Internal analyses by Arthrex to conclude acceptability of certain parameters (e.g., torque values).
Predicate Device Performance: The underlying assumption that if the new device performs equivalently to previously cleared predicate devices in these tests, it is safe and effective.

8. The sample size for the training set:

This is not applicable. The device is a physical implant, not a machine learning model that requires a training set.

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

This is not applicable for the same reason mentioned in point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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".

December 20, 2022

Arthrex Inc. Rebecca Homan Team Lead, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K221031

Trade/Device Name: Arthrex DualCompression Hindfoot Fusion Nail Implant System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: November 30, 2022 Received: November 30, 2022

Dear Rebecca Homan:

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

{1}------------------------------------------------

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) 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,

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is from Victoria A. Lilling -S. The date of the signature is 2022.12.20. The time of the signature is 15:31:51 -05'00'.

Victoria Lilling, M.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K221031

Device Name

Arthrex DualCompression Hindfoot Fusion Nail Implant System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
【X】 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.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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."

{3}------------------------------------------------

510(k) Summary

Date Prepared	December 19, 2022
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Rebecca R. HomanTeam Lead, Regulatory Affairs – Product Development1-239-643-5553, ext. 73429rebecca.homan@arthrex.com
Name of Device	Arthrex DualCompression Hindfoot Fusion Nail Implant System
Common Name	Rod, Fixation, Intramedullary And Accessories
Product Code	HSB
Classification Name	21 CFR 888.3020: Intramedullary fixation rod
Regulatory Class	II
Predicate Device	K090857: Wright Medical VALOR Ankle Fusion Nail System
Reference Device	K142602: Wright Medical VALOR Hindfoot Fusion Nail SystemK171376: Medshape Solutions DynaNail TTC Fusion SystemK113828: Medshape Solutions DynaNail Ankle Arthrodesis Nail
Purpose of Submission	This Traditional 510(k) premarket notification is submitted to obtain clearance forthe Arthrex DualCompression Hindfoot Fusion Nail Implant System.
Device Description	The Arthrex DualCompression Hindfoot Fusion Nail Implant System is comprisedof the Arthrex DualCompression Hindfoot Fusion Nails, Interlocking Screws, Cableand End Caps. The Arthrex DualCompression Hindfoot Nail is available in 10.5,11.5 and 12.5 mm diameters and lengths of 180, 210, 240 and 300 mm. TheInterlocking Screws are fully threaded, headed or headless, self-tapping, solid,low profile screws. The screw family is 5.0 mm in diameter and ranges from 20mm to 120 mm in length (in 2 or 5 mm increments). The End Caps are designedto prevent bone in growth in the distal portion of the Nail implant for ease ofremoval. The end cap family ranges from 1 to 11 mm in length for variouscountersinking depths.The Arthrex DualCompression Hindfoot Fusion Nails are manufactured fromTitanium Alloy (Ti-6AL-4V conforming to ASTM F136), Superelastic Nitinol(conforming to ASTM F2063) and Polyetheretherketone (PEEK)(conforming toASTM F2026). The Arthrex DualCompression Hindfoot Nail is sold sterile and issingle-use. The Interlocking Screws and End Caps are manufactured fromTitanium Alloy (Ti-6AL-4V conforming to ASTM F136). The Interlocking Screwsand End Caps are sold non-sterile and are single-use.
Indications for Use	The Arthrex DualCompression Hindfoot Fusion Nail Implant System is intended tofacilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity,arthritis, instability, and skeletal defects after tumor resection. These includeneuro-osteoarthropathy (Charcot's Foot), avascular necrosis of the talus, failedjoint replacement, failed ankle fusion, distal tibia fracture non-unions,osteoarthritis, rheumatoid arthritis, and pseudoarthrosis.
Performance Data	Static four-point bend, static torque, dynamic compression bending fatigue,fatigue strength, static and dynamic 3-point bend (ASTM F1264-16e1), axial pull-out, maximum torque, and breaking angle (ASTM F543-17) testing was conductedto demonstrate that the Arthrex DualCompression Hindfoot Fusion Nail ImplantSystem performs equivalent to the predicate devices cleared under K090857.

	Corrosion resistance (ASTM F2129), fretting corrosion (ASTM F1875, ATM F897)and bend and free recovery (ASTM F2082/F2082M) testing was conducted on theArthrex DualCompression Hindfoot Fusion Nail Implant System. An in-vitrofretting corrosion (ASTM F1875) and ion release (ASTM F3306) study wasconducted on the Arthrex DualCompression Hindfoot Fusion Nail Implant System.Arthrex preformed engineering analyses to conclude that the insertion torque,failure torque, driving torque and removal torque values of the Arthrex
	DualCompression Hindfoot Fusion Nail Implant System were acceptable.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.
	Bacterial Endotoxins Test (BET) was performed on the Arthrex DualCompressionHindfoot Fusion Nail Implant System utilizing the Kinetic Chromogenic Method inaccordance 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 ArthrexDualCompression Hindfoot Fusion Nail Implant System meet pyrogen limitspecifications.
	Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity,Subchronic/Subacute Toxicity, Implantation and Material Characterization testingwas conducted on the devices within the Arthrex DualCompression HindfootFusion Nail Implant System in accordance with ISO 10993-1:2018.
	Assessment of physical product attributes including product, design, size, andmaterials has determined that the Arthrex DualCompression Hindfoot Fusion NailImplant System does not introduce additional risks or concerns regardingsterilization and shelf-life.
TechnologicalComparison	The Arthrex DualCompression Hindfoot Fusion Nail Implant System issubstantially equivalent to the primary predicate devices cleared under K090857;and reference devices cleared under K142602, K171376 and K113828 in whichthe basic design features, intended use and fundamental scientific technology areidentical.
	The Arthrex DualCompression Hindfoot Fusion Nail Implant System is comprisedof the Arthrex DualCompression Hindfoot Fusion Nails, Interlocking Screws, Cableand End Caps.
	The Arthrex DualCompression Hindfoot Nail is available in 10.5, 11.5and 12.5 mm proximal diameters (with a 12.5 mm distal diameter)and lengths of 180, 210, 240 and 300 mm. The ArthrexDualCompression Hindfoot Fusion Nails are manufactured from

{4}------------------------------------------------

{5}------------------------------------------------

Titanium Alloy (Ti-6AL-4V conforming to ASTM F136), Superelastic Nitinol (conforming to ASTM F2063) and Polyetheretherketone (PEEK)(conforming to ASTM F2026). The Arthrex DualCompression Hindfoot Fusion Nails are sold sterile and are single-use. ● The Interlocking Screws are fully threaded, headed or headless selftapping solid low profile screws. The headed and headless screw family is 5.0 mm in diameter and ranges from 20 mm to 120 mm in length (in 2 or 5 mm increments). The End Cap family ranges from 1 to 11 mm in length for various countersinking depths The Interlocking Screws and End Caps are manufactured from Titanium Alloy (Ti-6AL-4V conforming to ASTM F136). The Interlocking Screws and End Caps are sold non-sterile and are single-use. . The Arthrex DualCompression Hindfoot Fusion Cable is manufactured from Stainless Steel (conforming to ASTM F138). The Arthrex DualCompression Hindfoot Fusion Cable is sold sterile and is single-use. The primary predicate device Wright Medical VALOR Ankle Fusion Nail System, K930834 is comprised of the Wright Medical VALOR Ankle Fusion Nails and screws. The nails were cleared in 10.0 and 11.5 proximal diameters (with a 12.5 mm distal diameter) and lengths of 150, 200 and 250 mm. The screws were cleared with a Ø5.0 mm diameter and lengths ranging from 20 mm to 100 mm. The nails and screws are manufactured from Titanium Alloy. The nails and screws are single-use. The reference device Wright Medical VALOR Hindfoot Fusion Nail System. K142602 is comprised of the Wright Medical VALOR Hindfoot Fusion Nails and screws. The nails were cleared in 10.0 and 11.5 proximal diameters (with a 12.0 mm distal diameter) and length of 300 mm. The screws were cleared with a Ø5.0 mm diameter and lengths ranging from 20 mm to 120 mm. The nails and screws are manufactured from Titanium Alloy. The nails and screws are single-use. The reference device Medshape Solutions DynaNail TTC Fusion System, K171376 is comprised of the Medshape Solutions DynaNail TTC Fusion Nails and screws. The nails were cleared in 10, 11 and 12 mm proximal diameters (with a 12.5 mm distal diameter) and length of 180, 220, 260, and 300 mm. The headed and headless screws were cleared with a Ø5.0 mm diameter and lengths ranging from 20 mm to 110 mm. The nails are manufactured from Titanium Alloy and Nitinol. The screws are manufactured from Titanium Alloy. The nails and screws are single-use. The reference device Medshape Solutions DynaNail Ankle Arthrodesis Nail, K113828 is comprised of the Medshape Solutions DynaNail Ankle Arthrodesis Nails and screws. The nails were cleared in 10, 11 and 12 mm proximal diameters (with a 12.5 mm distal diameter) and length of 180, 220, 260, and 300 mm. The headed and headless screws were cleared with a Ø5.0 mm diameter and lengths ranging from 20 mm to 110 mm. The nails are manufactured from Titanium Alloy and Nitinol. The screws are manufactured from Titanium Alloy. The nails and screws are single-use.

{6}------------------------------------------------

	The Arthrex DualCompression Hindfoot Fusion Nail Implant System wasevaluated for MR Conditional labeling, while the MRI Safety of primary predicatedevices cleared under K090857 and reference devices cleared under K142602,K171376 and K113828 is unknown.
	The Arthrex DualCompression Hindfoot Fusion Nail Implant System issubstantially equivalent to the primary predicate devices cleared under K090857;and reference devices cleared under K142602, K171376 and K113828, with minordimensional modifications with no change to intended use or function. Anydifferences between the Arthrex DualCompression Hindfoot Fusion Nail ImplantSystem and the predicate devices are considered minor and do not raisedifferent questions of safety or effectiveness.
Conclusion	The Arthrex DualCompression Hindfoot Fusion Nail Implant System issubstantially equivalent to the predicate devices cleared under K090857,K142602, K171376 and K113828; in which the basic design features and intendeduse are the same. Any differences between the Arthrex DualCompressionHindfoot Fusion Nail Implant System and the predicate devices are consideredminor and do not raise different questions of safety or effectiveness.
	The submitted mechanical testing data demonstrates that the static four-pointbend, static torque, dynamic compression bending fatigue, fatigue strength,static and dynamic 3-point bend and axial pull-out strength of the ArthrexDualCompression Hindfoot Fusion Nail Implant System is substantially equivalentto that of the predicate devices for the desired indications.
	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.

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.