(260 days)
No
The device description and associated information, including "Mentions AI, DNN, or ML: Not Found," indicate that this is a physical surgical device and does not involve AI.
Yes
The device is intended for surgical procedures to repair Pectus Excavatum and other anterior chest wall deformities, which constitutes a therapeutic purpose by correcting a physical anomaly.
No
Explanation: The ARIX Pectus Bar System is described as a surgical implant used to correct physical deformities. Its purpose is to lift the sternum and fix it to coastal ribs, which is a therapeutic rather than a diagnostic function. The provided text does not mention any diagnostic capabilities or intended use for medical assessment.
No
The device description explicitly states it "consists of pectus bar and stabilizer" and "includes appliance accessories used in surgical procedures to insert a fixation bar." This indicates it is a physical hardware device, not software-only. The performance studies also describe physical bench tests like bending and tensile tests, which are performed on hardware.
No.
The device is an implantable surgical device used to correct a physical deformity, not a diagnostic tool that provides information about a patient's health status from in vitro examination of specimens.
N/A
Intended Use / Indications for Use
ARIX Pectus Bar System is intended for use in surgical procedures to repair Pectus Excavatum and other anterior chest wall deformities.
Product codes
HRS
Device Description
ARIX Pectus Bar System is used in a minimally invasive surgical procedure to correct pectus excavatum, a type of deformity of the thoracic wall, characterized by a concave shaped chest.
This device consists of pectus bar and stabilizer to lift the sternum upwards to lessen the severity of the deformity.
ARIX Pectus Bar System includes appliance accessories used in surgical procedures to insert a fixation bar into the thoracic cavity and get it fixed to the coastal ribs for repairing pectus excavatum, a type of deformity of the thoracic wall.
Depending on the method of connection, Pectus Bars are used in combination of three types (Single Bar System, Double Bar System, Multi Bar System).
Especially, Single Bar System is used only for the Lower Bar, and the Upper Bar cannot be used alone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic wall, sternum, coastal ribs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 F382
- 4-point bending test
- 4-point bending fatigue test
- Vertical tensile test
- 3-point bending test
- 3-point bending fatigue test
The results of this testing indicate that the ARIX Pectus Bar System is equivalent to the predicate device.
No clinical studies were considered necessary and performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
FDA Approval Letter for ARIX Pectus Bar System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
May 30, 2025
Jeil Medical Corporation
Hong Soomin
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: K242751
Trade/Device Name: ARIX Pectus Bar System
Regulation Number: 21 CFR 888.3030
Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories
Regulatory Class: Class II
Product Code: HRS
Dated: September 12, 2024
Received: April 30, 2025
Dear Hong Soomin:
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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K242751 - Hong Soomin 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-
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K242751 - Hong Soomin 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,
CHRISTOPHER FERREIRA -S
Christopher Ferreira, MS
Assistant Director
DHT6C: Division of Restorative, Repair and Trauma
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)
K242751
Device Name
ARIX Pectus Bar System
Indications for Use (Describe)
ARIX Pectus Bar System is intended for use in surgical procedures to repair Pectus Excavatum and other anterior chest wall deformities.
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."
Page 5
510(K) Summary
[As required by 21 CFR 807.92]
K242751
1. Date Prepared [21 CFR 807.92(a)(a)]
May 28, 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: Soomin Hong / RA Specialist
- Telephone No. +82 2 850 3278
- Fax No. +82 2 850 3536
- Email Address: soominhong@jeilmed.co.kr
- Registration Number: 3004049923
- Name of Manufacturer Same as Sponsor
- Adress: Same as Sponsor
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
- Trade Name; ARIX Pectus Bar System
- Common Name; Plate, Fixation, Bone
- Classification Name; Single/multiple component metallic bone fixation appliances and accessories.
- Classification Panel; Orthopedic
- Classification Regulation; 21 CFR 888.3030
- Product Code; HRS
- Device Class; II
Page 6
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 K191057 – Park's Pectus Bar System, TDM CO., LTD
Reference Device K233912 – ARIX Cannulated Screw 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 Pectus Bar System is used in a minimally invasive surgical procedure to correct pectus excavatum, a type of deformity of the thoracic wall, characterized by a concave shaped chest.
This device consists of pectus bar and stabilizer to lift the sternum upwards to lessen the severity of the deformity.
ARIX Pectus Bar System includes appliance accessories used in surgical procedures to insert a fixation bar into the thoracic cavity and get it fixed to the coastal ribs for repairing pectus excavatum, a type of deformity of the thoracic wall.
Depending on the method of connection, Pectus Bars are used in combination of three types (Single Bar System, Double Bar System, Multi Bar System).
Especially, Single Bar System is used only for the Lower Bar, and the Upper Bar cannot be used alone.
6. Indications for use [21 CFR 807.92(a)(5)]
ARIX Pectus Bar System is intended for use in surgical procedures to repair Pectus Excavatum and other anterior chest wall deformities.
Page 7
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 F382
- 4-point bending test
- 4-point bending fatigue test
- Vertical tensile test
- 3-point bending test
- 3-point bending fatigue test
The results of this testing indicate that the ARIX Pectus Bar 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 (Design features, Material, Surface Treatment, Sterilization methods, Biocompatibility and Performance)
9. Conclusion [21 CFR 807.92(b)(3)]
In all respects, the ARIX Pectus Bar 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.