The ARIX Ankle Distal Tibia System is intended for fixation of complex intra- and extraarticular fractures and osteotomies of the distal tibia including distal tibia fractures in combination with diaphyseal fracture.

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-6Al-4V), which meet ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The plates vary essentially through different lengths and number of plate holes. The screws are selftapping, which are applied with the reconstruction locking screws together. The Screws are provided with diameter 3.5mm and 4.0mm. And Screws are provided with lengths from 10mm to 110mm.

AI/ML Overview

The provided document is a 510(k) summary for the "ARIX Ankle Distal Tibia System," a device intended for bone fixation. However, it explicitly states, "No clinical studies were considered necessary and performed." Therefore, there is no information available within this document regarding acceptance criteria or a study proving the device meets those criteria, as no clinical study was conducted.

The document focuses on demonstrating substantial equivalence to a predicate device (K170313) through bench tests and technological characteristics comparison. The bench tests conducted verified the device met design specifications and complied with ASTM standards for metallic bone plates and screws.

Here's a breakdown of what can be extracted from the document, acknowledging the absence of clinical study data:

1. A table of acceptance criteria and the reported device performance:

Since no clinical study was performed, there are no reported clinical performance criteria or results. The document mentions bench test results indicating compliance with ASTM standards, these would act as performance criteria for mechanical characteristics.

Acceptance Criteria (from Bench Tests)	Reported Device Performance
Compliance with ASTM F382 (Metallic Bone Plates)	Complies
Compliance with ASTM F543 (Metallic Medical Bone Screws)	Complies
4-Point Bending Test (Plate)	Results indicate equivalence to predicate device
4-Point Fatigue Test (Plate)	Results indicate equivalence to predicate device
Driving Torque Test (Screw)	Results indicate equivalence to predicate device
Torsion Test (Screw)	Results indicate equivalence to predicate device
Axial Pull-out Test (Screw)	Results indicate equivalence to predicate device

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not specified for the bench tests.
Data Provenance: The bench tests were conducted internally by the manufacturer ("Non-Clinical Test Summary"). The geographical origin is therefore Korea, South (location of Jeil Medical Corporation). The data is by definition prospective (designed and executed for this submission).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as no clinical study was performed. The "ground truth" for the non-clinical bench tests is established by the ASTM standards and mechanical engineering principles.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable as no clinical study was performed. Adjudication methods are typically used in clinical trials to resolve discrepancies in expert evaluations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable as no clinical study was performed and this device is a physical bone fixation system, not an AI-assisted diagnostic or therapeutic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable as this device is a physical bone fixation system, not an algorithm.

7. The type of ground truth used:

For the bench tests, the "ground truth" is defined by the ASTM standards (ASTM F382, ASTM F543), which set the criteria for mechanical properties, and the performance of the predicate device (K170313), against which the subject device's performance was compared for equivalence.

8. The sample size for the training set:

This information is not applicable as no clinical study was performed. A "training set" typically refers to data used to train machine learning models or for initial clinical observations, neither of which are mentioned here.

9. How the ground truth for the training set was established:

This information is not applicable as no clinical study was performed and therefore no training set.

Summary

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Image /page/0/Picture/0 description: The image shows the date October 29, 2020. The text is written in a clear, serif font. The date is presented in a standard format, with the month, day, and year clearly indicated. The text is horizontally aligned and evenly spaced.

Jeil Medical Corporation Ahhveon Woo 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: K202912

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: September 25, 2020 Received: September 29, 2020

Dear Ahhyeon Woo:

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.

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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 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 (OS) 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 medical devices and radiation-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, MPH 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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug Administration	Expiration Date: 06/30/2023
Indications for Use
510(k) Number (if known)	K202912
Device Name	ARIX Ankle Distal Tibia System
Indications for Use (Describe)	The ARIX Ankle Distal Tibia System is intended for fixation of complex intra- and extraarticular fractures and osteotomies of the distal tibia including distal tibia fractures in combination with diaphyseal fracture.
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 ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@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."

FORM FDA 3881 (6/20)

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BF PSC Publishing Survices (301) 443-6740

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702·703·704·705·706 Digital-ro 34-gil, Guro-qu, S Tel : +82 2 850 3591 / Fax : +82 2 850

510(k) Summary

[As required by 21 CRF 807.92]

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

25th September 2020

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-ro34-gil, Guro-gu, Seoul, 08378, Korea . Contact Name: Ahhyeon Woo / RA Specialist
- Telephone No. : +82 2 850 3591 --Fax No. : +82 2 850 3536
- Email Address : uah0606@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:	Bone Plate and Bone Screw
•	Classification Name:	Plate, Fixation, Bone
•	Classification Description:	Single/multiple component metallic bone fixationappliances and accessories
•	Classification Panel:	Orthopedic
•	Classification Regulation:	21 CFR 888.3030
•	Product Code:	HRS, HWC
•	Device Class:	II

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

The identified predicate device within this submission are shown as follow;

Primary Predicate	K170313 - ARIX Ankle Distal Tibia SystemJeil Medical Corporation
Other Predicates	K172008 - ARIX Humerus SystemJeil Medical CorporationK001945 - SYNTHES (USA) MEDIAL DISTAL TIBIA PLATESSYNTEHS(USA)

There are no significant differences between the subject device and the predicate device (K170313) that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, and operational principles 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-6Al-4V), which meet ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility.

The plates vary essentially through different lengths and number of plate holes. The screws are selftapping, which are applied with the reconstruction locking screws together. The Screws are provided with diameter 3.5mm and 4.0mm. And Screws are provided with lengths from 10mm to 110mm.

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

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

ARIX Ankle Distal Tibia System, Bone Plate:

Based on a technical feature comparison, the subject device was found to be similar to all predicate devices with regard to design and materials. The subject plates also have a variable locking feature, similar to the design used in the predicate device (K170313).

ARIX Ankle Distal Tibia System, Bone Screw:

ARIX Ankle Distal Tibia System Screws consist of the cleared "ARIX Ankle Distal Tibia System (K170313)" and "ARIX Humerus System (K172008)". The new added model, 40-SA series screw share similar head, neck and thread designs that are currently cleared under the reference device (K172008).

Non-Clinical Test Summary:

Bench tests were conducted to verify that the subject device met all design specifications. The test result 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 Method for Metallic Medical Bone Screws ●

The following tests were performed with the predicate device:

. Plate
- 4-Point Bending Test
- 4-Point Fatigue Test
Screw .
- Driving Torque Test
- Torsion Test
- Axial Pull-out Test

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.

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

When compared to the predicate device (K170313), the ARIX Ankle Distal Tibia System presented in this submission has the same:

. Indication for Use
Technological characteristics ●
Operating principle ●

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. Design features
Performance .
. Biocompatibility
Materials
Method of sterilization .

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

In all respects, the ARIX Ankle Distal Tibia System is the equivalent of currently marketed devices. This device is made of same materials and has similar dimensions and characteristics. The ARIX Ankle Distal Tibia System is manufactured from the titanium alloy that is used generally in this kind of bone plate and bone screw system. Based on the information submitted, ARIX Ankle Distal Tibia System is substantially equivalent to the currently marketed predicate devices.

Regulation Number and Section

§ 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.