Arthrex Intramedullary Nails

K230257 · Arthrex, Inc. · HSB · Jul 17, 2023 · Orthopedic

Device Facts

• Record ID: K230257
• Device Name: Arthrex Intramedullary Nails
• Applicant: Arthrex, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Jul 17, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Intramedullary nail systems (femoral, tibial, trochanteric) for orthopedic fracture fixation; includes nails, locking screws, end caps, spacers, washers. Manufactured from Titanium Alloy (ASTM F136) and Stainless Steel (ASTM F138). Used by surgeons in clinical/OR settings for stabilization of long bone fractures. Provides mechanical support to bone segments to facilitate healing. Sold sterile, single-use. Differences from predicates involve size variations and sterile packaging configurations; MR Conditional labeling added.

Clinical Evidence

Bench testing only. Includes packaging validation, 5-year accelerated aging shelf-life testing (ISO 11607), and MR safety testing (ASTM F2052, F2119, F2182, F2213). Bacterial Endotoxins Test (BET) performed per ANSI/AAMI ST72, USP <161>, USP <85>, and EP 2.6.14.

Technological Characteristics

Materials: Titanium Alloy (Ti-6AL-4V ELI, ASTM F136) and Stainless Steel (316LVM, ASTM F138). Mechanical fixation via intramedullary rods and locking screws. Sterile, single-use. MR Conditional.

Indications for Use

Indicated for patients requiring intramedullary fixation of femoral fractures (antegrade/retrograde), tibial fractures, or proximal femoral fractures (trochanteric/ES trochanteric). Includes open/closed fractures, pathologic fractures, nonunions, malunions, pseudoarthrosis, and osteoporotic bone fractures.

Regulatory Classification

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.

Predicate Devices

• AOS Intramedullary Nail (K133081)
• AOS Galileo Trochanteric Nail System (K202099)
• AOS Antegrade Femoral Nail System (K141228)
• AOS Retrograde Femoral Nail System (K132005)
• AOS 12 mm and 13 mm Tibial Nails (K130625)
• AOS Antegrade Femoral Nail System (K123569)
• AOS ES Trochanteric Nail (K103533)
• AOS Tibial Nail (K070444)
• Advanced Orthopaedic Solutions Trochanteric Nail (K021008)

Reference Devices

• Arthrex 2.4 mm Volar Distal Radius Plate System (K222267)
• Arthrex DualCompression Hindfoot Fusion Nail System (K221031)
• Arthrex Ankle Fracture System (K213837)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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

| <span style="font-family: Arial;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-----------------------------------------------------------------------------------------|
| <span style="font-family: Arial;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# Indications for Use

510(k) Number (if known) K230257

Device Name Arthrex Intramedullary Nails

#### Indications for Use (Describe)

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.

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

| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### 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

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## Indications for Use

510(k) Number (if known) K230257

Device Name Arthrex Intramedullary Nails

#### Indications for Use (Describe)

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.

* | 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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# 510(k) Summary

| Date Prepared | 07/14/2023 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 |
| Contact Person | Stacy Valdez<br>Senior Regulatory Affairs Specialist<br>1-239-643-5553, ext. 72010<br>[e-mail] |
| 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 System<br>K141228: AOS Antegrade Femoral Nail System<br>K132005: AOS Retrograde Femoral Nail System<br>K130625: AOS 12 mm and 13 mm Tibial Nails<br>K123569: AOS Antegrade Femoral Nail System<br>K103533: AOS ES Trochanteric Nail<br>K070444: AOS Tibial Nail<br>K021008: Advanced Orthopaedic Solutions Trochanteric Nail |
| Reference Device(s) | K222267: Arthrex 2.4 mm Volar Distal Radius Plate System<br>K221031: Arthrex DualCompression Hindfoot Fusion Nail System<br>K213837: Arthrex Ankle Fracture System |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain<br>clearance for the Arthrex Intramedullary Nails. |
| Device Description | The Arthrex Intramedullary Nails are comprised of Femoral, Tibial, and<br>Trochanteric Nail Systems.<br><br>The proposed Arthrex Femoral Nail System is comprised of femoral nails<br>(antegrade, retrograde, supracondylar retrograde), proximal and distal<br>locking screws, end caps, spacer, and washers. All retrograde nails are<br>threaded on the distal end to accept an end cap. The proximal and distal<br>locking screws are comprised of fully threaded, cancellous or cortical<br>screws and partially threaded cancellous screws. The Arthrex Femoral<br>Nail System is manufactured from Titanium Alloy (Ti-6AL-4V ELI<br>conforming to ASTM F136). The Arthrex Femoral Nail System is sold<br>sterile and is single-use.<br><br>The proposed Arthrex Tibial Nail System is comprised of tibial nails,<br>proximal and distal locking screws, end caps, and spacer of varying<br>lengths and diameters. The tibial nail contains slots to accept the locking<br>screws. The proximal and distal locking and blocking screws are<br>comprised of fully threaded, cortical screws and partially threaded<br>cannulated cancellous screws. The end caps are designed to prevent<br>bony in-growth in the distal portion of the nail implant. The spacer is<br>provided for proximal locking. The Arthrex Tibial Nail System is<br>manufactured from Titanium Alloy (Ti-6AL-4V ELI confirming to ASTM<br>F136). The Arthrex Tibial Nail System is sold sterile and single-use. |
| | The proposed Arthrex Trochanteric Nail System is comprised of<br>trochanteric nails (short, ES [Extended Short], and long), proximal and<br>distal locking screws, and end caps. The trochanteric nails have slots to<br>accept distal and proximal screws. The proximal end of the nail is<br>threaded to accept an end cap. The Arthrex Trochanteric Nail System<br>(nails, screws, and end caps) is manufactured from Titanium Alloy (Ti-<br>6AL-4V ELI conforming to ASTM F136) and Stainless Steel (316LVM<br>conforming to ASTM F138). |
| Indications for Use | The antegrade femoral nail is intended for use in intramedullary fixation<br>of fractures of the femur to include the following: Open and closed<br>femoral fractures, Pseudoarthrosis and correction osteotomy,<br>Pathologic fractures, impending pathologic fractures and tumor<br>resections, Supracondylar fractures, including those with severe<br>comminution and intra articular extension, Ipsilateral femur fractures,<br>bone lengthening, fractures proximal to a total knee arthroplasty or<br>prosthesis, fractures distal to a hip joint, nonunions and malunions, and<br>fractures resulting from osteoporosis. |
| | The retrograde femoral nail is intended for use in intramedullary fixation<br>of fractures of the femur to include the following: Open and closed<br>femoral fractures, Pseudoarthrosis and correction osteotomy,<br>Pathologic fractures, impending pathologic fractures and tumor<br>resections, Supracondylar fractures, including those with severe<br>comminution and intra articular extension, Ipsilateral femur fractures,<br>bone lengthening, fractures proximal to a total knee arthroplasty or<br>prosthesis, fractures distal to a hip joint, nonunions and malunions, and<br>fractures resulting from osteoporosis. |
| | The tibial nail system intended to provide temporary stabilization of<br>various types of fractures, malunions, and nonunions of the tibia. The<br>tibial nail system is indicated for long bone fracture fixation of tibial<br>fractures, which may include the following: traverse, oblique, spiral,<br>segmental and comminuted fractures; fractures with bone loss and bone<br>transport; open and closed fractures, pathologic fractures; corrective<br>osteotomies; pseudarthrosis of the tibial shaft; nonunions, malunions,<br>metaphyseal and epiphyseal fractures. |
| | The trochanteric nail is intended to treat stable and unstable proximal<br>fractures of the femur including peritrochanteric, intertrochanteric and<br>high subtrochanteric fractures and combinations of these fractures. The<br>long trochanteric nail is additionally indicated for subtrochanteric<br>fractures, peritrochanteric fractures associated with shaft fractures,<br>pathologic fractures (including prophylactic use) in osteoporotic bone of<br>the trochanteric and diaphyseal areas, long subtrochanteric fracture,<br>ipsilateral femoral fractures, proximal and distal non-unions and<br>malunions and revisions procedures. |
| | The ES trochanteric nail is intended to treat stable and unstable<br>proximal fractures of the femur including peritrochanteric,<br>intertrochanteric and high subtrochanteric fractures and combinations<br>of these fractures. |
| Performance Data | Arthrex conducted packaging validation and 5-year accelerated aging |
| | shelf-life testing to demonstrate that the packaging configurations are<br>capable of maintaining and protecting the product and sterility of the<br>device throughout the shipping and handling environment. The<br>proposed packaging configurations met all the packaging testing<br>acceptance criteria in conformance to ISO 11607 and applicable<br>standards.<br>MRI force, torque, and image artifact testing were conducted in<br>accordance with FDA guidance Testing and Labeling Medical Devices for<br>Safety in the Magnetic Resonance (MR) Environment, ASTM F2052<br>Standard Test Method for Measurement of Magnetically Induced<br>Displacement Force on Medical Devices in the Magnetic Resonance<br>Environment, ASTM F2119 Standard Test Method for Evaluation of MR<br>Image Artifacts from Passive Implants, ASTM F2182 Standard Test<br>Method for Measurement of Measurement of Radio Frequency Induced<br>Heating Near Passive Implants During Magnetic Resonance Imaging and<br>ASTM F2213 Standard Test Method for Measurement of Magnetically<br>Induced Torque on Medical Devices in the Magnetic Resonance<br>Environment. |
| | Bacterial Endotoxins Test (BET) was performed on the Arthrex<br>Intramedullary Nails utilizing the Kinetic Chromogenic Method in<br>accordance with ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>,<br>EP 2.6.14. The testing conducted demonstrates that the sterile devices<br>within the Arthrex Tibial Nail System meet pyrogen limit specifications. |
| Technological Comparison | The Arthrex Femoral Nail System was previously cleared as the AOS<br>Femoral Nail System under K141228, K133081, K132005, and K123569.<br>The Arthrex Femoral Nail System is substantially equivalent to the<br>predicate devices cleared under K133081 in which the intended use,<br>fundamental scientific technology, design, material, sterility, and shelf-<br>life are identical. |
| | The Arthrex Tibial Nail System was previously cleared as the AOS Tibial<br>Nail System under K070444, K130625, and K133081. The Arthrex Tibial<br>Nail System is substantially equivalent to the predicate devices cleared<br>under K133081 in which the intended use, fundamental scientific<br>technology, design, material, sterility, and shelf-life are identical. |
| | The Arthrex Trochanteric Nail System was previously cleared as the AOS<br>Trochanteric Nail System under K012190, K021008, K070444, K103533,<br>K120148, K123569, K133081, and K202099. The Arthrex Trochanteric<br>Nail System is substantially equivalent to the predicate devices cleared<br>under K133081 in which the intended use, fundamental scientific<br>technology, design, material, sterility, and shelf-life are identical. |
| | The Arthrex Femoral Nail System (sterile nails) are offered larger in<br>proximal diameter and shorter/longer lengths than the primary<br>predicate AOS Intramedullary Nail, K133081. The larger proximal<br>diameter and shorter/longer lengths of the sterile nails were originally<br>cleared as non-sterile under additional predicate devices AOS Antegrade<br>Femoral Nail System, K123569 and AOS Retrograde Femoral Nail<br>System, K132005. |
| | The Arthrex Trochanteric Nail System (sterile nails) are longer in length<br>than the primary predicate AOS Intramedullary Nail, K133081. The<br>longer length of the sterile nails were originally cleared as non-sterile<br>under additional predicate device AOS Galileo Trochanteric Nail System,<br>K202099. |
| | The Arthrex Tibial Nail System (sterile screws) are offered in shorter and<br>longer lengths than the primary predicate AOS Intramedullary Nail,<br>K133081. The shorter and longer lengths of the sterile screws were<br>originally cleared as non-sterile under additional predicate device AOS<br>Tibial Nail, K070444. |
| | The Arthrex Trochanteric Nail System (sterile screws) are offered in<br>shorter and longer lengths than the primary predicate AOS<br>Intramedullary Nail, K133081. The shorter and longer lengths of the<br>sterile screws were originally cleared as non-sterile under additional<br>predicate device Advanced Orthopaedic Solutions Trochanteric Nail,<br>K021008. |
| | The Arthrex Tibial Nail System (sterile end cap) is a larger size than the<br>primary predicate AOS Intramedullary Nail, K130081. However, the<br>larger size was originally cleared as non-sterile under additional<br>predicate device AOS Antegrade Femoral Nail System, K123569. |
| | The sterile packaging for the Arthrex Intramedullary Nails is changing to<br>a double nylon/nylon pouch (for the nails), a double PETG blister tray<br>with Tyvek lidding (for the screws, end caps, and spacer), and a double<br>PETG blister tray with Tyvek lidding or double poly/Tyvek pouch (for the<br>washers). These are existing packaging configurations cleared under<br>reference device Arthrex 2.4 mm Volar Distal Radius Plate System,<br>K222267 and Arthrex Ankle Fracture System, K213837. |
| | The Arthrex Intramedullary Nails were evaluated for MR Conditional<br>labeling. The primary predicate AOS Intramedullary Nail, K133081 was<br>not evaluated for MR Safety. |
| | The Arthrex Intramedullary Nails is substantially equivalent to the<br>predicate devices cleared under K133081, with minor modifications with<br>no change to the intended use, design, or function. Any differences<br>between the Arthrex Intramedullary Nails and the predicate devices are<br>considered minor and do not raise different questions of safety or<br>effectiveness. |
| Conclusion | The Arthrex Intramedullary Nails are substantially equivalent to the<br>predicate devices cleared under K133081 in which the basic design<br>features and intended use are the same. Any differences between the<br>Arthrex Intramedullary Nails and the predicate devices are considered<br>minor and do not raise different questions of safety or effectiveness.<br>Based on the indications for use, technological characteristics, and the<br>summary of data submitted, Arthrex Inc. has determined that the<br>proposed device is substantially equivalent to the currently marketed<br>predicate devices. |

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