(152 days)
No
The device description focuses on the physical components (plates and screws) and materials. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are bench tests of mechanical properties, not algorithmic performance.
Yes
The device is intended for internal fixation, reconstruction, and arthrodesis of small bones, which are therapeutic procedures aimed at treating conditions affecting these bones.
No
The device is described as rigid fixation consisting of plates and screws intended for internal fixation, reconstruction, or arthrodesis of small bones, not for diagnosing conditions.
No
The device description explicitly states it is a rigid fixation system consisting of plates and screws made of titanium, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- ARIX Foot System Description: The description clearly states that the ARIX Foot System is a system of plates and screws intended for internal fixation and reconstruction of bones in the foot and ankle. This is a surgical implant used inside the body.
The information provided about the device's intended use, description, materials, and performance studies all point to it being a surgical implant, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The ARIX Foot System (2.3/2.8) is intended for use in internal fixation, reconstruction, or arthrodesis of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusion, corrective osteotomies, and the treatment of fractures.
Product codes
HRS, HWC
Device Description
The ARIX Foot System (2.3/2.8) is rigid fixation consisting of plates and screws in various confiqurations, shapes and sizes.
The ARIX Foot System (2.3/2.8) is made of Unalloyed 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 screws are self-tapping with various diameters, which are applied with the reconstruction locking screws together. The Cortical Screws, locking screws & self-drilling screws are provided with diameter 2.0 mm to 2.8 mm and lengths from 6 mm to 46 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones including the fore, mid- and hind foot and ankle.
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 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
- Dimension Test
- 4-Point Bending Test
- 4-Point Fatigue Test
- Screw
- Dimension Test
- Driving Torque Test
- Torsion Test
- Axial Pullout Test
The results of this testing indicate that the ARIX Foot System (2.3/2.8) is equivalent to predicate device.
No clinical studies were considered necessary and performed.
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Jeil Medical Corporation Yein Han RA Specialist #702. Kolon Science Vallev 2nd 55, Digital-ro 34, Guro-gu Seoul, 152-728 Korea
August 14, 2017
Re: K170780 Trade/Device Name: ARIX Foot System (2.3/2.8) 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: July 3, 2017 Received: July 5, 2017
Dear Yein Han:
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
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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.
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/0 description: The image shows the logo for JEIL MEDICAL CORPORATION, followed by the address and contact information. 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 3934, and the fax number is +82 2 850 3536. The logo features the company name in a sans-serif font, with the word "MEDICAL" stacked on top of "CORPORATION".
Indication for Use
510(k) Number (if known): K170780
Device Name: ARIX Foot System (2.3/2.8)
Indication for Use:
The ARIX Foot System (2.3/2.8) is intended for use in internal fixation, reconstruction, or arthrodesis of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusion, corrective osteotomies, and the treatment of fractures.
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)
3
Image /page/3/Picture/2 description: The image contains the logo for JEIL MEDICAL CORPORATION. Below the logo is the address: 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, 152-728, Korea. The phone and fax numbers are also listed: Tel: +82 2 850 3934 / Fax: +82 2 850 3536.
510(k) Summary
[As required by 21 CRF 807.92]
1. Date Prepared [21 CRF 807.92(a)(a)]
March 14, 2017
●
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-ho,55 |
Digital-ro34-gil, Guro-gu, Seoul, 152-728, Korea |
- Contact Name: Yein Han / RA Specialist .
- Telephone No. : +82 2 850 3934 -
- Fax No. : +82 2 850 3536 -
- Email Address : hyi@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 Foot System (2.3/2.8) |
---|---|
• Common Name: | Bone Plate and Screw |
• Classification Name: | Plate, Fixation, Bone / Screw, Fixation, Bone |
• Classification Description: | Single/multiple component metallic bone fixation |
appliances and accessories | |
Smooth or threaded metallic bone fixation fastener | |
• Classification Panel: | Orthopedic |
• Classification Regulation: | 21 CFR 888.3030 / 21 CFR 888.3040 |
• Product Code: | HRS / HWC |
• Device Class: | II |
4
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicate devices within this submission are shown as follow;
- Predicate Devices
• 510(k) Number: | K052614 |
---|---|
• Device Name: | Low Profile Plate and Screw System |
• 510(k) Number: | K131311 |
---|---|
• Device Name: | ARIX Foot System |
- Reference Predicate Devices
• 510(k) Number: | K112812 |
---|---|
• Device Name: | Leforte Neuro System Bone Plate |
• 510(k) Number: | K151468 |
---|---|
• Device Name: | ARIX Wrist System |
• 510(k) Number: | K132876 | ||
---|---|---|---|
-- | --------------------- | --------- | -- |
- ARIX Hand Locking System . Device Name:
There are no significant differences between the subject devices 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 Foot System (2.3/2.8) is rigid fixation consisting of plates and screws in various confiqurations, shapes and sizes.
The ARIX Foot System (2.3/2.8) is made of Unalloyed 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 screws are self-tapping with various diameters, which are applied with the reconstruction locking screws together. The Cortical Screws, locking screws & self-drilling screws are provided with diameter 2.0 mm to 2.8 mm and lengths from 6 mm to 46 mm.
6. Indication for use [21 CFR 807.92(a)(5)]
The ARIX Foot System (2.3/2.8) is intended for use in internal fixation, reconstruction, or arthrodesis of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.
5
Image /page/5/Picture/2 description: The image shows the logo and contact information for JEIL MEDICAL CORPORATION. The logo features the company name in orange and gray text, with a stylized graphic of three overlapping shapes in green, orange, and gray to the left of the name. Below the logo is the company's address: 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, 152-728, Korea. The telephone and fax numbers are also listed: Tel: +82 2 850 3934 / Fax: +82 2 850 3536.
7. Technological Characteristics [21 CFR 807.92(a)(6)
ARIX Foot System (2.3/2.8), 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 polyaxial locking feature, similar to the design used in the predicate device.
ARIX Foot System (2.3/2.8), Bone Screw: They share similar head, neck and thread designs as the smaller screws that are currently cleared under the predicate device.
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 .
- Dimension Test
- 4-Point Bending Test
- 4-Point Fatigue Test
- . Screw
- Dimension Test
- Driving Torque Test
- Torsion Test
- Axial Pullout Test
The results of this testing indicate that the ARIX Foot System (2.3/2.8) 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 devices, the ARIX Foot System (2.3/2.8) presented in this submission has similar:
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Image /page/6/Picture/2 description: The image shows the logo for JEIL MEDICAL CORPORATION, followed by the address 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, 152-728, Korea. The phone number is Tel: +82 2 850 3934 and the fax number is Fax: +82 2 850 3536.
- Indication for Use
- Technological characteristics
- Operating principle ●
- Design features
- . Performance
- Biocompatibility ●
- Materials ●
- Method of sterilization .
9. Conclusion [21 CFR 807.92(b)(3)]
In all respects, the ARIX Foot System (2.3/2.8) is the equivalent of currently marketed devices. This device is made of same materials and has similar dimensions and characteristics. The ARIX Foot System (2.3/2.8) is manufactured from the unalloyed titanium and titanium alloy that are used generally in this kind of bone plate and screw system. Based on the information submitted, ARIX Foot System (2.3/2.8) is substantially equivalent to the currently marketed predicate devices.