ARIX Femur Nail System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone).

Device Description

Anti-Rotation Lag Screw and Telescopic Lag Screw in ARIX Femur Nail System are made of Titanium Alloy which meets ASTM F136 and only 'Anti-Rotation Pin' section of Anti-Rotation Lag Screw is made of Nickel-Titanium Alloy which meets ASTM F2063. ARIX Femur Nail System is provided Sterile or Non-Sterile.

AI/ML Overview

N/A

Summary

FDA 510(k) Clearance Letter - ARIX Femur Nail System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.02

December 10, 2025

Jeil Medical Corporation
Dajung Lee
RA Specialist
702•703•704•705•706•707•804•805•807•812•815-ho, 55
Digital-ro 34-gil, Guro-gu
Seoul, 08378
Republic Of Korea

Re: K252826
Trade/Device Name: ARIX Femur Nail System
Regulation Number: 21 CFR 888.3020
Regulation Name: Intramedullary fixation rod
Regulatory Class: Class II
Product Code: HSB
Dated: September 5, 2025
Received: November 10, 2025

Dear Dajung Lee:

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 (the 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 available 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.

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K252826 - Dajung Lee
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K252826 - Dajung Lee
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assistance/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,

Farzana Sharmin -S

Farzana Sharmin, PhD
Assistant Director
DHT6A: Division of Joint Arthroplasty Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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K252826

Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.	K252826
Please provide the device trade name(s).

ARIX Femur Nail System

Please provide your Indications for Use below.

Please select the types of uses (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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K252826

702•703•704•705•706•707•804•805•807•812•815-ho,
55, Digital-ro 34-gil, Guro-gu, Seoul, 08378, Republic of Korea
Tel: +82 2 850 3500 / Fax: +82 2 850 3535

Page 1 of 3
ARIX Femur Nail System

510(K) Summary

[As required by 21 CFR 807.92]

1. Date Prepared [21 CFR 807.92(a)(a)]

September 05, 2025

2. Submitter's Information [21 CFR 807.92(a)(1)]

Name of Sponsor: Jeil Medical Corporation
- Address: 702•703•704•705•706•707•804•805•807•812•815-ho, 55, Digital-ro 34-gil, Guro-gu, Seoul, 08378, Republic of Korea
Contact Name: Dajung Lee / RA Specialist
- Telephone No. +82 2 850 3591
- Fax No. +82 2 850 3536
- Email Address: dajunglee@jeilmed.co.kr
Registration Number: 3004049923
Name of Manufacturer Jeil Medical Corporation
- Address: 702•703•704•705•706•707•804•805•807•812•815-ho, 55, Digital-ro 34-gil, Guro-gu, Seoul, 08378, Republic of Korea

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Trade Name: ARIX Femur Nail System
Common Name: Rod, Fixation, Intramedullary And Accessories
Classification Name: Intramedullary fixation rod
Classification Panel: Orthopedic
Classification Regulation: 21 CFR 888.3020
Product Code: HSB
Device Class: II

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K252826

702•703•704•705•706•707•804•805•807•812•815-ho,
55, Digital-ro 34-gil, Guro-gu, Seoul, 08378, Republic of Korea
Tel: +82 2 850 3500 / Fax: +82 2 850 3535

Page 2 of 3
ARIX Femur Nail System

4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The legally marketed device(s) to which substantial equivalence is claimed is/are:

Primary Predicate Device K200869 - Gamma3 System, Stryker Trauma GmbH

Reference Device K242247 – ARIX Femur Nail System, Jeil Medical Corporation
K231251 - FlexWing Anterior Cervical Plate System, Jeil Medical Corporation
K202099 - AOS Galileo™ Trochanteric Nail System, Advanced Orthopaedic Solutions, Inc.

There are no significant differences between the subject device and the predicate device that would adversely affect the use of the product. It is substantially equivalent to these devices in intended use and technological characteristics as internal fixation components.

5. Description of the Device [21 CFR 807.92(a)(4)]

6. Indications for use [21 CFR 807.92(a)(5)]

7. Technological Characteristics [21 CFR 807.92(a)(6)]

Based on the technological feature comparison, the subject device was found that there are no significant differences between the subject device and predicate devices that would adversely affect the use of the product and it is substantially equivalent to predicate device in technological characteristics.

Non-Clinical Test Summary:

Bench tests were conducted to ensure the safety and effectiveness of the device as well as to demonstrate substantial equivalence to the predicate device. The test results demonstrated that the subject device complies with the following standards:

ASTM F384-17, Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
- Full Construction Static Test
- Full Construction Fatigue Test
- Corrosion Assessment
Others
- Cut-out Performance Test
- Testing in accordance with the ASTM F1264-16 Standard

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K252826

702•703•704•705•706•707•804•805•807•812•815-ho,
55, Digital-ro 34-gil, Guro-gu, Seoul, 08378, Republic of Korea
Tel: +82 2 850 3500 / Fax: +82 2 850 3535

Page 3 of 3
ARIX Femur Nail System

The results of this testing indicate that the ARIX Femur Nail System is equivalent to the predicate device.

Clinical Test Summary:
No clinical studies were considered necessary and performed.

8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]

Based on the submitted information in this premarket notification, the subject device is substantially equivalent to the predicate device in terms of:

Intended use
Technological characteristics (Shape / Configuration, Specification, Materials, Surface Treatment, Sterilization, Biocompatibility and Performance)

The subject device has met the performance, safety, and effectiveness of the device for its intended use.

9. Conclusion [21 CFR 807.92(b)(3)]

The subject device has equivalent intended use and technological characteristics. Further, nonclinical verification and validation to determine substantial equivalence provide additional evidence that subject device is substantially equivalent to the predicate device in terms of safety and effectiveness.

Regulation Number and Section

N/A