ARIX Ankle Distal Tibia System

{0}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Jeil Medical Corporation Sejin Ryu RA Specialist #702. Kolon Science Vallev 2nd 55 Digital-ro 34. Guro-gu Seoul, 152-728 Korea July 27, 2017 Re: K170313 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: June 30, 2017 Received: July 3, 2017 Dear Sejin Ryu: 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 {1}------------------------------------------------ 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 (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, ## Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for JEIL MEDICAL CORPORATION, followed by their address and contact information. The address is #702, Kolon Science Valley 2nd, 811 Guro-Dong, Guro-Gu, Seoul, 152-728 Korea. The telephone number is +82 2 850 3500, and the fax number is +82 2 850 3536. The logo features the company name in a stylized font, with a graphic of three colored dots above the letters. # Indications for Use 510(k) Number (if known): K170313 Device Name: ARIX Ankle Distal Tibia System Indications for Use: 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. 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 {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for JEIL MEDICAL CORPORATION. The logo features a colorful abstract design to the left of the company name, with "JEIL" in a bold orange font and "MEDICAL CORPORATION" in a smaller gray font. Below the logo is the text "#702, Kolon Science Valley 2nd, 811". Gu. Seoul Tel : +82 2 850 3500 / Fax : +82 2 8 ## 510(k) Summary [As required by 21 CFR 807.92] ## 1. Date Prepared [21 CFR 807.92(a)(1)] 26 January 2017 ## 2. Submitter's Information [21 CFR807.92(a)(1)] - . Name of Sponsor: Jeil Medical Corporation - . #702, Kolon Science Valley 2nd Address: 811, Guro-dong, Guro-gu Seoul, 152-728, Korea - Contact Name: Sejin RYU / RA Specialist - Telephone No. : +82 2 850 3500 — - Fax No. : +82 2 850 3536 — - Email Address : rsj@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 Screw | | • Classification Name: | Plate, Fixation, Bone / Screw, Fixation, Bone | | • Classification Description: | Single/multiple component metallic bone fixation<br>appliances and accessories<br>Smooth or threaded metallic bone fixation fastener | | • Classification Panel: | Orthopedic | | • Classification Regulation: | 21 CFR 888.3030<br>21 CFR 888.3040 | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo and contact information for JEIL MEDICAL CORPORATION. The logo features a stylized smiling face with green, yellow, orange, and gray colors. Below the logo is the company's address: #702, Kolon Science Valley 2nd, 811 Guro-Dong, Guro-Gu, Seoul, 152-728 Korea. The phone number is +82 2 850 3500, and the fax number is +82 2 850 3536. - Product Code: HRS / HWC ● - Device Class: ll ## 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follows: #### - Primary Predicate Devices | • 510(k) Number: | K013248 | |------------------|---------------------------------| | • Device Name: | Synthes LCP Distal Tibia Plates | #### - Additional Predicate Devices | • 510(k) Number: | K163044 | |------------------|--------------------------------------------| | • Device Name: | Ortholoc 3Di Ankle Fracture Plating System | - 510(k) Number: K103705 ● Device Name: Low Profile Screws #### - Reference Predicate Devices | • 510(k) Number: | K112812 | |------------------|----------------| | • Device Name: | LeForte System | - 510(k) Number: K151468 ● Device Name: ARIX Wrist System ● - 510(k) Number: K131311 ● Device Name: ARIX Foot System - 510(k) Number: K132876 ● Device Name: ARIX Hand Locking System There are no significant differences between the Model ARIX Ankle Distal Tibia System and the predicate devices (K013248, K163044, K103705) 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}------------------------------------------------ Image /page/5/Picture/1 description: The image contains the logo for JEIL MEDICAL CORPORATION, along with their address and contact information. The address is #702, Kolon Science Valley 2nd, 811 Guro-Dong, Guro-Gu, Seoul, 152-728 Korea. The telephone number is +82 2 850 3500, and the fax number is +82 2 850 3536. The logo features the company name in orange and gray, with a stylized graphic of people in blue, green, orange, and gray. ## 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, as follows: | | Plate | Cortical Screw | Locking Screw | |------------------------|----------------------------------------------|----------------------------------------------|----------------------------------------------| | Type/<br>Configuration | Medial Type | | | | | Anterolateral<br>Type | 28-SO-L Series | 28L-SO-L Series | | | T Type | 35-SO-L Series | 35L-SO-L Series | | | | | | | Material | ASTM F 136,<br>Titanium Alloy<br>(Ti-6Al-4V) | ASTM F 136,<br>Titanium Alloy<br>(Ti-6Al-4V) | ASTM F 136,<br>Titanium Alloy<br>(Ti-6Al-4V) | 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 self-tapping, which are applied with the reconstruction locking screws together. The Cortical Screws & locking screws are provided with diameter 2.8 mm to 3.5 mm and lengths from 8 mm to 80 mm. ARIX Ankle Distal Tibia System is provided as Gold color which is casted according to the anodizing technique while apply 5 V electric energy to the titanium. It also includes various manual surqical instruments, such as drill bits, counter sink, depth gauge, compression, drill guide, drill sleeve, guide pin, bender and screw driver handle. The ARIX Ankle Distal Tibia 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. The sterilization method is presented in the instruction, which was validated per ISO 17665-1: 2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices. ## 6. Indication for Use [21 CFR 807.92(a)(5)] 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. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo and contact information for JEIL MEDICAL CORPORATION. The logo features a stylized design with green, gray, and orange elements, along with the company name in bold letters. Below the logo is the address: #702, Kolon Science Valley 2nd, 811 Guro-Dong, Guro-Gu, Seoul, 152-728 Korea. The telephone number is +82 2 850 3500, and the fax number is +82 2 850 3536. ### 7. Technological Characteristics [21 CFR 807.92(a)(6)] ARIX Ankle Distal Tibia System, Bone Plates: Based on a technical feature comparison, the subject device was found to be similar to predicate devices with regard to design and materials. The subject plates also have a locking feature, similar to the design used in the predicate device (K013248). ARIX Ankle Distal Tibia System, Bone Screws: They share similar head, neck, and thread designs as the screws that are currently cleared under the predicate device (K013248). #### 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 382-14, Standard Specification and Test Method for Metallic Bone Plates - ASTM F 543-13, Standard Specification and Test Methods for Metallic Medical Bone Screws The following tests were performed with the predicate device: - . Plates - । Bending strength test per ASTM F382 - Bending fatigue test per ASTM F382 — - Screw - Driving torque test per ASTM F543 — - Torsion test per ASTM F543 — - Axial pull out test per ASTM F543 । 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. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo and contact information for JEIL MEDICAL CORPORATION. The logo features a stylized graphic with the company name beside it. Below the logo is the address: #702, Kolon Science Valley 2nd, 811 Guro-Dong, Guro-Gu, Seoul, 152-728 Korea. The telephone number is +82 2 850 3500 and the fax number is +82 2 850 3536. ### 8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92] When compared to the predicate device (K013248) the ARIX Ankle Distal Tibia System presented in this submission has the same: - Intended Use - . Technological characteristics - . Operating principle - . Design features - . Performance - Biocompatibility - Materials - Method of sterilization and sterility assurance level . ## 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 the same materials and has similar dimensions and characteristics. This device is manufactured from titanium that is used generally in this kind of bone plate/screw system. This device, ARIX Ankle Distal Tibia System, is substantially equivalent in design, material, and function to the predicate device.