(56 days)
Not Found
No
The device description focuses on the physical components (plates, screws, instruments) and materials, and the performance studies are bench tests evaluating mechanical properties against standards. There is no mention of AI, ML, image processing, or data-driven analysis.
No
The device is used for internal fixation of the distal fibula, providing rigid support rather than delivering therapy.
No
Explanation: The device is described as rigid fixation consisting of plates and screws intended for internal fixation of the distal fibula. It is a surgical implant designed for treatment, not for diagnosing a condition or disease.
No
The device description explicitly states it consists of plates, screws, and manual surgical instruments made of titanium, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "internal fixation of the distal fibula." This is a surgical procedure performed directly on the patient's body to stabilize a bone fracture.
- Device Description: The device consists of plates, screws, and surgical instruments. These are all physical implants and tools used during surgery.
- Lack of Diagnostic Function: The description does not mention any function related to analyzing samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information. IVDs are used to diagnose diseases or conditions.
This device is a surgical implant system used for orthopedic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ARIX Ankle System(Fibula) is intended for use in internal fixation of the distal fibula.
Product codes
KTT
Device Description
The ARIX Ankle System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes as follow:
Straight Plate: 35-DLST Series, Material: ASTM F 67 Pure Titanium
Lateral Plate: 35-DLFI Series, Material: ASTM F 67 Pure Titanium
Cortical Screw: 35-HF Series, Material: ASTM F 136 Titanium Alloy (Ti-6Al-4V)
Locking Screw: 35L-HF Series, Material: ASTM F 136 Titanium Alloy (Ti-6Al-4V)
The ARIX Ankle System is made of Pure Titanium and Titanium Alloy (Ti-6AL-4V), which meet ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications. and 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 cortical screws, locking screws diameter is 3.5mm lengths is from 10mm to 70mm. It also includes various manual surgical instruments, as drill guides, drill bits, driver shafts, depth gauge, bender and handbody etc., The ARIX Ankle System not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10° by the hospital prior to surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal fibula
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
Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards: ASTM F 382-99, Standard Specification and Test Method for Metallic Bone Plates; ASTM F 543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws. The following tests were performed with the predicate devices: Plates (Dimension test, Single Cycle Bending test per ASTM F382, Bending Fatigue test per ASTM F382) and Screws (Dimension test, Driving torque test per ASTM F543-07, Axial pull-out test per ASTM F543-07, Torsion test per ASTM F543-07). The results of this testing indicate that the ARIX Ankle System is equivalent to predicate devices. No clinical studies were considered necessary and performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all capital letters.
September 28, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Jeil Medical Corporation Jiwon KANG RA Specialist 702•703•704•705•706•804•805•807•812-ho, 55, Digital-ro34-gil, Guro-gu Seoul-City, 152-728 Republic of KOREA
Re: K152158
Trade/Device Name: ARIX Ankle System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: KTT Dated: August 26, 2015 Received: August 27, 2015
Dear Ms. Jiwon KANG:
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. 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.
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/1 description: The image shows the logo for JEIL MEDICAL CORPORATION. The logo consists of a colorful abstract graphic on the left, followed by the word "JEIL" in orange, and then the words "MEDICAL CORPORATION" in gray, stacked on top of each other. The abstract graphic is made up of several different colored shapes, including green, blue, gray, and orange.
702-703-704-705-706-804-805-807-812 10. 55. Digital-ro34-gil, Guro-gu, 152-728, Korea Tel : +82 2 850 3500 / Fax : +82 2 850 3535
Indication for Use
510(k) Number (if known):
Device Name: ARIX Ankle System
Indication for Use:
The ARIX Ankle System(Fibula) is intended for use in internal fixation of the distal fibula.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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Image /page/3/Picture/0 description: The image shows the logo for JEIL MEDICAL CORPORATION. The logo consists of a stylized graphic to the left of the company name. The graphic includes a gray crescent shape, a green circle, and a blue circle. The company name is written in orange and gray.
702-703-704-705-706-804-805-807 Digital-ro34-gil, Guro-qu. 152-728, Korea Tel : +82 2 850 3500 / Fax : +82 2 850 3535
510(k) Summary
[As required by 21 CRF 807.92]
1. Date Prepared [21 CRF 807.92(a)(a)]
- 21 August 2015
2. Submitter's Information [21 CFR 807.92(a)(1)]
- . Name of Sponsor: Jeil Medical Corporation
- 702-703-704-705-706-804-805-807-812-ho, 55 -Address: Digital-ro34-gil, Guro-gu, Seoul, 152-728, Korea
- Contact Name: Jiwon KANG (Ms.) / RA Specialist o
- Telephone No. : +82 2 850 3500 =
- Fax No. : +82 2 850 3525 =
- -Email Address : jwkang@jeilmed.co.kr
- . Registration Number: 3004049923
- Name of Manufacturer: Same as Sponsor o
- Same as Sponsor -Address:
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
- o Trade Name: ARIX Ankle System
- Common Name: . Bone plates and screws
- . Classification Name: Single/multiple component metallic bone fixation appliances and accessories
- . Classification Panel: Orthopedic
- Classification Regulation: 21 CFR 888.3030 ●
- KTT Product Code: .
- . Device Class: =
General Information
4
Image /page/4/Picture/0 description: The image shows the logo for JEIL Medical Corporation. The logo consists of a colorful abstract design on the left, followed by the text "JEIL" in a bold, sans-serif font. To the right of "JEIL" is the word "MEDICAL" stacked on top of the word "CORPORATION", both in a smaller, lighter font.
702-703-704-705-706-804-805-807-812 Digital-ro34-qil, Guro-qu, 152-728, Korea Tel : +82 2 850 3500 / Fax : +82 2 850 3535
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicate devices within this submission are shown as follow;
- 510(k) Number: . K081284
- 0 Applicant: HOWMEDICA OSEONICS CORP.
- . Common Name: plate, fixation, bone
- VariAXTM Distal Fibula Plate Device Name: e
There are no significant differences between the Model ARIX Ankle System and the predicate devices 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 System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes as follow:
| Straight Plate | Lateral Plate | Cortical Screw | Locking Screw | |
|---|---|---|---|---|
| Type | ||||
| Configuration | 35-DLST Series | 35-DLFI Series | 35-HF Series | 35L-HF Series |
| Material | ASTM F 67 | |||
| Pure Titanium | ASTM F 67 | |||
| Pure Titanium | ASTM F 136 | |||
| Titanium Alloy | ||||
| (Ti-6Al-4V) | ASTM F 136 | |||
| Titanium Alloy | ||||
| (Ti-6Al-4V) |
The ARIX Ankle System is made of Pure Titanium and Titanium Alloy (Ti-6AL-4V), which meet ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications. and 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 cortical screws, locking screws diameter is 3.5mm lengths is from 10mm to 70mm. It also includes various manual surgical instruments, as drill guides, drill bits, driver shafts, depth gauge, bender and handbody etc., The ARIX Ankle System not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10° by the hospital prior to surgery.
This device performance is not adversely affected by aging or storage conditions since this device is to be sterilized at the hospital before use and also to be single use.
5
Image /page/5/Picture/0 description: The image shows the logo for JEIL MEDICAL CORPORATION. The logo features a stylized graphic to the left of the text. The graphic consists of several curved shapes in different colors, including blue, green, gray, and orange. To the right of the graphic, the text "JEIL" is displayed in a large, bold font, with the word "MEDICAL" above the word "CORPORATION" in a smaller font.
702-703-704-705-706-804-805-807 Digital-ro34-gil, Guro-gu, 152-728, Tel : +82 2 850 3500 / Fax : +82 2 850 3535
6. Intended Use [21 CFR 807.92(a)(5)]
The ARIX Ankle System(Fibula) is intended for use in internal fixation of the distal fibula.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
ARIX Ankle System, Bone Plates: 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 poly axial locking feature, similar to the design used in the predicate devices (K081284 ).
ARIX Ankle System, Bone Screws: They share similar head, neck and thread designs as the smaller screws that are currently cleared under the predicate devices (K081284).
Non-Clinical Test Summary:
Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards;
- . ASTM F 382-99, Standard Specification and Test Method for Metallic Bone Plates
- ASTM F 543-07, Standard Specification and Test Methods for Metallic Medical Bone 9 Screws
The following tests were performed with the predicate devices:
- · Plates
- Dimension test -
- -Single Cycle Bending test per ASTM F382
- Bending Fatigue test per ASTM F382 」
- Screws .
- Dimension test -
- -Driving torque test per ASTM F543-07
- Axial pull-out test per ASTM F543-07 _
- Torsion test per ASTM F543-07 l
The results of this testing indicate that the ARIX Ankle System is equivalent to predicate devices.
Clinical Test Summary:
No clinical studies were considered necessary and performed.
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Image /page/6/Picture/0 description: The image shows the logo and contact information for JEIL MEDICAL CORPORATION. The address is 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, 152-728, Korea. The telephone number is +82 2 850 3500, and the fax number is +82 2 850 3535.
8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]
When compared to the predicate devices (K081284), the ARIX Ankle System presented in this submission has the same;
- Intended Use ●
- 0 Technological characteristics
- Operating principle .
- . Design features
- Performance .
- 0 Biocompatibility
- . Materials
- Method of sterilization and sterility assurance level .
9. Conclusion [21 CFR 807.92(b)(3)]
In all the respects, the ARIX Ankle System is the equivalent of currently marketed devices. This device is made of the same materials and has similar dimensions and characteristics. This device is manufactured from material of the Pure Titanium and Titanium Alloy, Unalloyed titanium and Wrought titanium alloy that is used generally in this kind of bone plate/screw system. This device, ARIX Ankle System, is substantially equivalent in design, material, and function to the predicate devices.