(170 days)
No
The device description and performance studies focus on the mechanical properties and equivalence to predicate devices, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML.
Yes.
The device facilitates arthrodesis of the ankle (tibiotalocalcaneal and tibiotalar joints), which is a surgical procedure to fuse bones to relieve pain and improve stability, indicating a therapeutic purpose.
No
The device is described as a "rigid fixation consisting of plates and screws" used for facilitating arthrodesis of the ankle, which points to a therapeutic or surgical function rather than a diagnostic one.
No
The device description explicitly states it is a system of rigid fixation consisting of plates and screws made of Titanium Alloy, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "facilitating arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints." This describes a surgical procedure to fuse bones in the ankle.
- Device Description: The device is described as "rigid fixation consisting of plates and screws." These are physical implants used in surgery.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
The ARIX Ankle Distal Tibia System is a surgical implant used in the body, not a device used to test samples from the body.
N/A
Intended Use / Indications for Use
The ARIX Ankle Distal Tibia System(Ankle fusion) is indicated for facilitating arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints.
Product codes
HRS, HWC
Device Description
The ARIX Ankle Distal Tibia System is rigid fixation consisting of plates and screws in various configurations, shapes, and sizes. The ARIX Ankle Distal Tibia System is made of Titanium Alloy (Ti-6AI-4V), which meet ASTM F136, Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle including tibiotalocalcaneal and tibiotalar joints
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
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, Standard Specification and Test Method for Metallic Bone Plates; ASTM F543, Standard Specification and Test Methods for Metallic Medical Bone Screws. The results of this testing indicate that the ARIX Ankle Distal Tibia System is equivalent to predicate device.
Key Metrics
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.
0
December 14, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the full name. The full name of the agency is "U.S. Food & Drug Administration".
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: K231887
Trade/Device Name: ARIX Ankle Distal Tibia 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, HWC Dated: November 7, 2023 Received: November 13, 2023
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.
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"
1
K231887 - Dajung Lee
(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 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-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 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.
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-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,
Shumaya Ali-S
Shumaya Ali, M.P.H.
Shumaya Ali, M.P.H Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K231887
Device Name ARIX Ankle Distal Tibia System
Indications for Use (Describe)
The ARIX Ankle Distal Tibia System(Ankle fusion) is indicated for facilitating arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints.
| 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)
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3
Digital-ro 34-gil. Guro-gu. Se Tel: +82 2 850 3591 / Fax: +82 2 850 3536
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
7th December 2023
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, 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: | Same as Sponsor |
|---|---|
| - Address: | Same as Sponsor |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| • | Trade Name; | ARIX Ankle Distal Tibia System |
|---|---|---|
| • | Common Name; | - Plate, Fixation, Bone (Primary) |
- Screw, Fixation, Bone |
| • | Classification Name; | - Single/multiple component metallic bone fixation appliances
and Accessories (Primary) - Smooth or threaded metallic bone fixation fastener |
| • | Classification Panel; | Orthopedic |
| • | Classification regulation; | 21 CFR 888.3030 (Primary), 21 CFR 888.3040 |
| • | Product code; | HRS (Primary), HWC |
| • | Device Class; | II |
4
Tel: +82.2.850.3591 / Fax:
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 | K181067 – AlignX Ankle Fusion System,
Extremity Medical, LLC. |
|----------------------------|-----------------------------------------------------------------------|
| Secondary Predicate Device | K141735 – Arthrex Ankle Fusion Plating System,
ARTHREX, INC. |
| Reference Device | K202912 – ARIX Ankle Distal Tibia System,
Jeil Medical Corporation |
There are no significant differences between the subject device and the predicate devices 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)]
The ARIX Ankle Distal Tibia System is rigid fixation consisting of plates and screws in various configurations, shapes, and sizes.
The ARIX Ankle Distal Tibia System is made of Titanium Alloy (Ti-6AI-4V), which meet ASTM F136, Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility.
6. Indications for use [21 CFR 807.92(a)(5)]
The ARIX Ankle Distal Tibia System(Ankle fusion) is indicated for facilitating arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
ARIX Ankle Distal Tibia System, Bone Plate, Bone Screw:
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, Standard Specification and Test Method for Metallic Bone Plates
- . ASTM F543, Standard Specification and Test Methods for Metallic Medical Bone Screws
The results of this testing indicate that the ARIX Ankle Distal Tibia System is equivalent to predicate device.
Clinical Test Summary
No clinical studies were considered necessary and performed.
5
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 devices in terms of:
- Intended use
- . Technological characteristics (Design features, Material, Surface Treatment, Sterilization methods, 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)]
In all respects, the ARIX Ankle Distal Tibia 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.