The antegrade femoral nail is intended for use in intramedullary fixation of fractures of the femur to include the following: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures and tumor resections, Supracondylar fractures, including those with severe comminution and intra articular extension, Ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions and malunions, and fractures resulting from osteoporosis.

The retrograde femoral nail is intended for use in intramedullary fixation of fractures of the femur to include the following: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures and tumor resections. Supracondylar fractures, including those with severe comminution and intra articular extension, Ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions, and fractures resulting from osteoporosis.

The tibial nail system is intended to provide temporary stabilization of various types of fractures, malunions, and nonunions of the tibia. The tibial nail system is indicated for long bone fracture fixation of tibial fractures, which may include the following: traverse, oblique, spiral, segmental and comminuted fractures with bone loss and bone transport; open and closed fractures; pathologic fractures; pseudarthrosis of the tibial shaft; nonunions, malunions, metaphyseal and epiphyseal fractures.

The trochanteric nail is intended to treat stable and unstable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures associated with shaft fractures pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral fractures, proximal and distal non-unions and malunions and revisions procedures.

The ES trochanteric nail is intended to treat stable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures.

Device Description

The Arthrex Intramedullary Nails are comprised of Femoral, Tibial, and Trochanteric Nail Systems.

The proposed Arthrex Femoral Nail System is comprised of femoral nails (antegrade, retrograde, supracondylar retrograde), proximal and distal locking screws, end caps, spacer, and washers. All retrograde nails are threaded on the distal end to accept an end cap. The proximal and distal locking screws are comprised of fully threaded, cancellous or cortical screws and partially threaded cancellous screws. The Arthrex Femoral Nail System is manufactured from Titanium Alloy (Ti-6AL-4V ELI conforming to ASTM F136). The Arthrex Femoral Nail System is sold sterile and is single-use.

The proposed Arthrex Tibial Nail System is comprised of tibial nails, proximal and distal locking screws, end caps, and spacer of varying lengths and diameters. The tibial nail contains slots to accept the locking screws. The proximal and distal locking and blocking screws are comprised of fully threaded, cortical screws and partially threaded cannulated cancellous screws. The end caps are designed to prevent bony in-growth in the distal portion of the nail implant. The spacer is provided for proximal locking. The Arthrex Tibial Nail System is manufactured from Titanium Alloy (Ti-6AL-4V ELI confirming to ASTM F136). The Arthrex Tibial Nail System is sold sterile and single-use.

The proposed Arthrex Trochanteric Nail System is comprised of trochanteric nails (short, ES [Extended Short], and long), proximal and distal locking screws, and end caps. The trochanteric nails have slots to accept distal and proximal screws. The proximal end of the nail is threaded to accept an end cap. The Arthrex Trochanteric Nail System (nails, screws, and end caps) is manufactured from Titanium Alloy (Ti-6AL-4V ELI conforming to ASTM F136) and Stainless Steel (316LVM conforming to ASTM F138).

AI/ML Overview

The provided FDA 510(k) summary (K230257) for the Arthrex Intramedullary Nails does not contain information related to software or AI/ML components. Therefore, it does not include acceptance criteria, study details, or performance metrics typically associated with such devices.

The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through:

Technological Comparison: Highlighting that the intended use, fundamental scientific technology, design, material, sterility, and shelf-life are identical or have minor modifications that do not raise new questions of safety or effectiveness.
Performance Data for Hardware Components: Detailing tests performed on the physical device components and packaging, such as:
- Packaging validation and 5-year accelerated aging shelf-life testing (conforming to ISO 11607).
- MRI safety testing (force, torque, image artifact, radiofrequency induced heating) in accordance with FDA guidance and ASTM standards (ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213).
- Bacterial Endotoxins Test (BET) to ensure pyrogen limit specifications are met (in accordance with ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14).

Therefore, I cannot answer questions 1 through 9 as they pertain to the evaluation of AI/ML or software performance. The device described is a physical medical implant (intramedullary nails) and the clearance is based on its similarity to existing, cleared hardware.

Summary

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Image /page/0/Picture/0 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.

July 17, 2023

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

Re: K230257

Trade/Device Name: Arthrex Intramedullary Nails Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: June 13, 2023 Received: June 15, 2023

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

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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 digitally signed document by Thomas McNamara. The document is signed on July 17, 2023, at 14:14:03. The document is for Farzana Sharmin, Ph.D., Assistant Director, DHT6A: Division of Joint Arthroplasty Devices, OHT6: Office of Orthopedic Devices, Office of Product Evaluation and Quality, and Center for Devices and Radiological Health.

Enclosure

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Indications for Use

510(k) Number (if known) K230257

Device Name Arthrex Intramedullary Nails

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)

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."

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Indications for Use

510(k) Number (if known) K230257

Device Name Arthrex Intramedullary Nails

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)

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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Indications for Use

510(k) Number (if known) K230257

Device Name Arthrex Intramedullary Nails

Indications for Use (Describe)

| 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	07/14/2023
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Stacy ValdezSenior Regulatory Affairs Specialist1-239-643-5553, ext. 72010Stacy.valdez@arthrex.com
Name of Device	Arthrex Intramedullary Nails
Common Name	Rod, Fixation, Intramedullary and Accessories
Product Code	HSB
Classification Name	21 CFR 888.3020: Intramedullary Fixation Rod
Regulatory Class	II
Primary Predicate Device	K133081: AOS Intramedullary Nail
Additional Predicate Device(s)	K202099: AOS Galileo Trochanteric Nail SystemK141228: AOS Antegrade Femoral Nail SystemK132005: AOS Retrograde Femoral Nail SystemK130625: AOS 12 mm and 13 mm Tibial NailsK123569: AOS Antegrade Femoral Nail SystemK103533: AOS ES Trochanteric NailK070444: AOS Tibial NailK021008: Advanced Orthopaedic Solutions Trochanteric Nail
Reference Device(s)	K222267: Arthrex 2.4 mm Volar Distal Radius Plate SystemK221031: Arthrex DualCompression Hindfoot Fusion Nail SystemK213837: Arthrex Ankle Fracture System
Purpose of Submission	This Traditional 510(k) premarket notification is submitted to obtainclearance for the Arthrex Intramedullary Nails.
Device Description	The Arthrex Intramedullary Nails are comprised of Femoral, Tibial, andTrochanteric Nail Systems.The proposed Arthrex Femoral Nail System is comprised of femoral nails(antegrade, retrograde, supracondylar retrograde), proximal and distallocking screws, end caps, spacer, and washers. All retrograde nails arethreaded on the distal end to accept an end cap. The proximal and distallocking screws are comprised of fully threaded, cancellous or corticalscrews and partially threaded cancellous screws. The Arthrex FemoralNail System is manufactured from Titanium Alloy (Ti-6AL-4V ELIconforming to ASTM F136). The Arthrex Femoral Nail System is soldsterile and is single-use.The proposed Arthrex Tibial Nail System is comprised of tibial nails,proximal and distal locking screws, end caps, and spacer of varyinglengths and diameters. The tibial nail contains slots to accept the lockingscrews. The proximal and distal locking and blocking screws arecomprised of fully threaded, cortical screws and partially threadedcannulated cancellous screws. The end caps are designed to preventbony in-growth in the distal portion of the nail implant. The spacer isprovided for proximal locking. The Arthrex Tibial Nail System ismanufactured from Titanium Alloy (Ti-6AL-4V ELI confirming to ASTMF136). The Arthrex Tibial Nail System is sold sterile and single-use.
	The proposed Arthrex Trochanteric Nail System is comprised oftrochanteric nails (short, ES [Extended Short], and long), proximal anddistal locking screws, and end caps. The trochanteric nails have slots toaccept distal and proximal screws. The proximal end of the nail isthreaded to accept an end cap. The Arthrex Trochanteric Nail System(nails, screws, and end caps) is manufactured from Titanium Alloy (Ti-6AL-4V ELI conforming to ASTM F136) and Stainless Steel (316LVMconforming to ASTM F138).
Indications for Use	The antegrade femoral nail is intended for use in intramedullary fixationof fractures of the femur to include the following: Open and closedfemoral fractures, Pseudoarthrosis and correction osteotomy,Pathologic fractures, impending pathologic fractures and tumorresections, Supracondylar fractures, including those with severecomminution and intra articular extension, Ipsilateral femur fractures,bone lengthening, fractures proximal to a total knee arthroplasty orprosthesis, fractures distal to a hip joint, nonunions and malunions, andfractures resulting from osteoporosis.
	The retrograde femoral nail is intended for use in intramedullary fixationof fractures of the femur to include the following: Open and closedfemoral fractures, Pseudoarthrosis and correction osteotomy,Pathologic fractures, impending pathologic fractures and tumorresections, Supracondylar fractures, including those with severecomminution and intra articular extension, Ipsilateral femur fractures,bone lengthening, fractures proximal to a total knee arthroplasty orprosthesis, fractures distal to a hip joint, nonunions and malunions, andfractures resulting from osteoporosis.
	The tibial nail system intended to provide temporary stabilization ofvarious types of fractures, malunions, and nonunions of the tibia. Thetibial nail system is indicated for long bone fracture fixation of tibialfractures, which may include the following: traverse, oblique, spiral,segmental and comminuted fractures; fractures with bone loss and bonetransport; open and closed fractures, pathologic fractures; correctiveosteotomies; pseudarthrosis of the tibial shaft; nonunions, malunions,metaphyseal and epiphyseal fractures.
	The trochanteric nail is intended to treat stable and unstable proximalfractures of the femur including peritrochanteric, intertrochanteric andhigh subtrochanteric fractures and combinations of these fractures. Thelong trochanteric nail is additionally indicated for subtrochantericfractures, peritrochanteric fractures associated with shaft fractures,pathologic fractures (including prophylactic use) in osteoporotic bone ofthe trochanteric and diaphyseal areas, long subtrochanteric fracture,ipsilateral femoral fractures, proximal and distal non-unions andmalunions and revisions procedures.
	The ES trochanteric nail is intended to treat stable and unstableproximal fractures of the femur including peritrochanteric,intertrochanteric and high subtrochanteric fractures and combinationsof these fractures.
Performance Data	Arthrex conducted packaging validation and 5-year accelerated aging
	shelf-life testing to demonstrate that the packaging configurations arecapable of maintaining and protecting the product and sterility of thedevice throughout the shipping and handling environment. Theproposed packaging configurations met all the packaging testingacceptance criteria in conformance to ISO 11607 and applicablestandards.MRI force, torque, and image artifact testing were conducted inaccordance with FDA guidance Testing and Labeling Medical Devices forSafety in the Magnetic Resonance (MR) Environment, ASTM F2052Standard Test Method for Measurement of Magnetically InducedDisplacement Force on Medical Devices in the Magnetic ResonanceEnvironment, ASTM F2119 Standard Test Method for Evaluation of MRImage Artifacts from Passive Implants, ASTM F2182 Standard TestMethod for Measurement of Measurement of Radio Frequency InducedHeating Near Passive Implants During Magnetic Resonance Imaging andASTM F2213 Standard Test Method for Measurement of MagneticallyInduced Torque on Medical Devices in the Magnetic ResonanceEnvironment.
	Bacterial Endotoxins Test (BET) was performed on the ArthrexIntramedullary Nails 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 deviceswithin the Arthrex Tibial Nail System meet pyrogen limit specifications.
Technological Comparison	The Arthrex Femoral Nail System was previously cleared as the AOSFemoral Nail System under K141228, K133081, K132005, and K123569.The Arthrex Femoral Nail System is substantially equivalent to thepredicate devices cleared under K133081 in which the intended use,fundamental scientific technology, design, material, sterility, and shelf-life are identical.
	The Arthrex Tibial Nail System was previously cleared as the AOS TibialNail System under K070444, K130625, and K133081. The Arthrex TibialNail System is substantially equivalent to the predicate devices clearedunder K133081 in which the intended use, fundamental scientifictechnology, design, material, sterility, and shelf-life are identical.
	The Arthrex Trochanteric Nail System was previously cleared as the AOSTrochanteric Nail System under K012190, K021008, K070444, K103533,K120148, K123569, K133081, and K202099. The Arthrex TrochantericNail System is substantially equivalent to the predicate devices clearedunder K133081 in which the intended use, fundamental scientifictechnology, design, material, sterility, and shelf-life are identical.
	The Arthrex Femoral Nail System (sterile nails) are offered larger inproximal diameter and shorter/longer lengths than the primarypredicate AOS Intramedullary Nail, K133081. The larger proximaldiameter and shorter/longer lengths of the sterile nails were originallycleared as non-sterile under additional predicate devices AOS AntegradeFemoral Nail System, K123569 and AOS Retrograde Femoral NailSystem, K132005.
	The Arthrex Trochanteric Nail System (sterile nails) are longer in lengththan the primary predicate AOS Intramedullary Nail, K133081. Thelonger length of the sterile nails were originally cleared as non-sterileunder additional predicate device AOS Galileo Trochanteric Nail System,K202099.
	The Arthrex Tibial Nail System (sterile screws) are offered in shorter andlonger lengths than the primary predicate AOS Intramedullary Nail,K133081. The shorter and longer lengths of the sterile screws wereoriginally cleared as non-sterile under additional predicate device AOSTibial Nail, K070444.
	The Arthrex Trochanteric Nail System (sterile screws) are offered inshorter and longer lengths than the primary predicate AOSIntramedullary Nail, K133081. The shorter and longer lengths of thesterile screws were originally cleared as non-sterile under additionalpredicate device Advanced Orthopaedic Solutions Trochanteric Nail,K021008.
	The Arthrex Tibial Nail System (sterile end cap) is a larger size than theprimary predicate AOS Intramedullary Nail, K130081. However, thelarger size was originally cleared as non-sterile under additionalpredicate device AOS Antegrade Femoral Nail System, K123569.
	The sterile packaging for the Arthrex Intramedullary Nails is changing toa double nylon/nylon pouch (for the nails), a double PETG blister traywith Tyvek lidding (for the screws, end caps, and spacer), and a doublePETG blister tray with Tyvek lidding or double poly/Tyvek pouch (for thewashers). These are existing packaging configurations cleared underreference device Arthrex 2.4 mm Volar Distal Radius Plate System,K222267 and Arthrex Ankle Fracture System, K213837.
	The Arthrex Intramedullary Nails were evaluated for MR Conditionallabeling. The primary predicate AOS Intramedullary Nail, K133081 wasnot evaluated for MR Safety.
	The Arthrex Intramedullary Nails is substantially equivalent to thepredicate devices cleared under K133081, with minor modifications withno change to the intended use, design, or function. Any differencesbetween the Arthrex Intramedullary Nails and the predicate devices areconsidered minor and do not raise different questions of safety oreffectiveness.
Conclusion	The Arthrex Intramedullary Nails are substantially equivalent to thepredicate devices cleared under K133081 in which the basic designfeatures and intended use are the same. Any differences between theArthrex Intramedullary Nails and the predicate devices are consideredminor and do not raise different questions of safety or effectiveness.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

§ 888.3020 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.