(265 days)
No
The provided text describes a medical device for fracture treatment made of titanium alloy, with no mention of AI models, machine learning, or image processing capabilities.
Yes
The device is indicated for the treatment of stable and unstable fractures, as well as for the stabilization of bones and correction of bone deformities, which are therapeutic interventions.
No
The ARIX Femur Nail System is an orthopedic implant designed for the treatment and stabilization of femur fractures and deformities. Its intended use is to treat existing conditions rather than to diagnose them.
No
The device description explicitly lists physical components made of Titanium Alloy (Nail, Lag Screw, Interlocking Screw, Set Screw, and End Cap), and the performance studies involve bench tests for mechanical properties, clearly indicating a hardware medical device.
No.
The device is an orthopedic implant for fixing bone fractures, not a diagnostic tool that examines specimens from the human body.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
ARIX Femur Nail System (Nail, Lag Screw, Interlocking Screw, Set Screw, and End Cap) is made of Titanium Alloy which meets ASTM F136. ARIX Femur Nail System is provided Sterile or Non-Sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur (intracapsular, trochanteric, subtrochanteric and shaft regions)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 F1264-16, Standard Specification and Test Methods for Intramedullary Fixation Devices
- 4-Point Bending Test
- 4-Point Bending Fatigue Test
- Torsional Test
- ASTM F384-17, Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
- Full Construction Static Test
- Full Construction Fatigue Test
- ASTM F543-23, Standard Specification and Test Methods for Metallic Medical Bone Screws
- Torsional Strength Test
- Driving Torque Test
- Axial Pull-out Load Test
- Others
- Cut-out Performance Test
The results of this testing indicate that the ARIX Femur Nail System is equivalent to the predicate device.
No clinical studies were considered necessary and performed.
- Cut-out Performance Test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
FDA 510(k) Clearance Letter - ARIX Femur Nail System
Page 1
April 22, 2025
Jeil Medical Corporation
Dajung Lee
RA Specialist
702•703•704•705•706•804•805•807•812•815-ho
55, Digital-ro 34-gil, Guro-gu
Seoul, 08378
Korea, South
Re: K242247
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: March 21, 2025
Received: March 21, 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.
Page 2
K242247 - Dajung Lee Page 2
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-
Page 3
K242247 - Dajung Lee Page 3
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,
Joseph P. Russell -S Digitally signed by Joseph P. Russell -S Date: 2025.04.22 08:12:00 -04'00'
for: 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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
K242247
Device Name
ARIX Femur Nail System
Indications for Use (Describe)
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).
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."
Page 5
510(K) Summary
[As required by 21 CFR 807.92]
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 4 ARIX Femur Nail System
1. Date Prepared [21 CFR 807.92(a)(a)]
April 18, 2025
2. Submitter's Information [21 CFR 807.92(a)(1)]
- Name of Sponsor: Jeil Medical Corporation
- Address: 702•703•704•705•706•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 3991
- Fax No. +82 2 850 3536
- Email Address: dajunglee@jeilmed.co.kr
- Registration Number: 3004049923
- Name of Manufacturer Same as Sponsor
- Address: Same as Sponsor
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
K242247
Page 1 of 4
Page 6
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 4 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 K212266 - FIX-C PEEK Anterior Cervical Interbody System, Jeil Medical Corporation
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)]
ARIX Femur Nail System (Nail, Lag Screw, Interlocking Screw, Set Screw, and End Cap) is made of Titanium Alloy which meets ASTM F136. ARIX Femur Nail System is provided Sterile or Non-Sterile.
6. Indications for use [21 CFR 807.92(a)(5)]
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).
K242247
Page 2 of 4
Page 7
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 4 ARIX Femur Nail System
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 F1264-16, Standard Specification and Test Methods for Intramedullary Fixation Devices
- 4-Point Bending Test
- 4-Point Bending Fatigue Test
- Torsional Test
-
ASTM F384-17, Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
- Full Construction Static Test
- Full Construction Fatigue Test
-
ASTM F543-23, Standard Specification and Test Methods for Metallic Medical Bone Screws
- Torsional Strength Test
- Driving Torque Test
- Axial Pull-out Load Test
-
Others
- Cut-out Performance Test
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, Design, Materials, Surface Treatment, Sterilization, Biocompatibility and Performance)
The subject device has met the performance, safety, and effectiveness of the device for its intended use.
K242247
Page 3 of 4
Page 8
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 4 of 4 ARIX Femur Nail System
9. Conclusion [21 CFR 807.92(b)(3)]
In all respects, the ARIX Femur Nail System is substantially equivalent to the legally marketed device. Above all, 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, efficacy, and performance.
K242247
Page 4 of 4