ARIX Clavicle System
Device Facts
| Record ID | K180972 |
|---|---|
| Device Name | ARIX Clavicle System |
| Applicant | Jeil Medical Corporation |
| Product Code | HRS · Orthopedic |
| Decision Date | Oct 3, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The ARIX Clavicle System is indicated for the fixation of single, segmental and comminuted fractures, malunions, and non-unions of the clavicle.
Device Story
ARIX Clavicle System consists of titanium alloy (Ti-6AL-4V) bone plates and screws; used for rigid internal fixation of clavicle fractures, osteotomies, malunions, and non-unions. Plates feature variable lengths and hole configurations; screws include self-tapping locking (2.5mm, 3.5mm) and cortical (3.5mm) types. Device is implanted by orthopedic surgeons in a clinical/surgical setting. System provides mechanical stabilization of bone segments to facilitate healing. No software or electronic components involved.
Clinical Evidence
No clinical studies were performed. Substantial equivalence is supported by bench testing, including 4-point bending and fatigue tests for plates, and driving torque, torsion, and axial pull-out tests for screws, demonstrating compliance with ASTM F382 and ASTM F543.
Technological Characteristics
Materials: Titanium Alloy (Ti-6AL-4V) per ASTM F136. Components: Bone plates and self-tapping screws (locking and cortical). Design: Variable locking feature. Standards: ASTM F382 (plates), ASTM F543 (screws). Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.
Indications for Use
Indicated for fixation of single, segmental, and comminuted fractures, osteotomies, malunions, and non-unions of the clavicle in patients requiring bone fixation.
Regulatory Classification
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.
Predicate Devices
- Superior Lateral Variax Clavicle Plate System (K130116)
- Acu-sinch Repair System And Acumed Suture Anchor (K112111)
- ARIX Wrist System (K170705)
- ARIX Diaphysis System (K171285)
Submission Summary (Full Text)
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October 3, 2018
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Jeil Medical Corporation Seungyong Lee RA Specialist 702,703,704,705,706,804,805,807,812,815-ho,55 Digital-ro34-gil, Guro-gu Seoul. KR 08378
Re: K180972
Trade/Device Name: ARIX Clavicle 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 4, 2018 Received: September 4, 2018
Dear Seungyong 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 (Act) that do not require approval of a premarket approval application (PMA). You mav, 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 avare 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.
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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tejen D. Soni -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K180972
Device Name
ARIX Clavicle System
Indications for Use (Describe)
The ARIX Clavicle System is indicated for the fixation of single, segmental and comminuted fractures, malunions, and non-unions of the clavicle.
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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K180972
Image /page/3/Picture/1 description: The image shows the logo for JEIL MEDICAL CORPORATION. The logo features a stylized graphic with a blue, green, gray, and orange color scheme. To the right of the graphic, the text "JEIL MEDICAL CORPORATION" is displayed in a modern, sans-serif font, with "MEDICAL" in a darker shade than "CORPORATION".
702-703-704-70 Digital-ro 34-gil, Guro-gu, Seoul, 0837 Tel : +82 2 850 3533 / Fax : +82 2 850 3536
# 510(k) Summary
[As required by 21 CRF 807.92]
## 1. Date Prepared [21 CRF 807.92(a)(a)]
11th April 2018
## 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 i Digital-ro34-gil, Guro-gu, Seoul, 08378, Korea
- Contact Name: Seungyong Lee / RA Specialist ●
- +82 2 850 3533 Telephone No. : -
- Fax No. : +82 2 850 3536 -
- -Email Address : leesy@jeilmed.co.kr
- Registration Number: o 3004049923
- Name of Manufacturer: Same as Sponsor o Address: Same as Sponsor ।
## 3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
- Trade Name: ARIX Clavicle System . o Common Name: Bone Plate and Bone Screw o Classification Name: Plate, Fixation, Bone / Screw, Fixation, Bone Classification Description: Single/multiple component metallic bone fixation o appliances and accessories Orthopedic Classification Panel: ● . Classification Regulation: 21 CFR 888.3030 Product Code: HRS, HWC ●
- Device Class: ll o
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Image /page/4/Picture/1 description: The image shows the logo and contact information for JEIL MEDICAL CORPORATION. The address is listed as 702-703-704-705-706-804-805-807-812-815-ho, 55, Digital-ro 34-gil, Guro-gu, Seoul, 08378, Korea. The telephone number is +82 2 850 3533, and the fax number is +82 2 850 3536.
## 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicate devices within this submission are shown as follow;
| Primary Predicate | K130116 - Superior Lateral Variax Clavicle Plate System<br>Stryker Trauma AG Plate |
|-----------------------|------------------------------------------------------------------------------------------|
| Additional Predicates | K112111 - Acu-sinch Repair System And Acumed Suture Anchor<br>Acumed LLC |
| | K170705 - ARIX Wrist System, K171285 - ARIX Diaphysis System<br>Jeil Medical Corporation |
There are no significant differences between the subject device and the predicate devices (K130116, K112111, K170705,K171285) 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 Clavicle System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes.
The ARIX Clavicle System is made of Titanium Alloy (Ti-6AL-4V), which meet ASTM F136, Standard Specification for Wrought Titanium-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 Locking Screws are provided with diameter 2.5, 3.5mm and Cortical Screws are provided with diameter 3.5mm. And both are provided with lengths from 6 mm to 110 mm.
## 6. Indication for use [21 CFR 807.92(a)(5)]
The ARIX Clavicle System is indicated for the fixation of single, segmental and comminuted fractures, osteotomies, mal-unions, and non-unions of the clavicle.
## 7. Technological Characteristics [21 CFR 807.92(a)(6)]
#### ARIX Clavicle System:
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 (K130116). The screws are similar in size compared to the predicates.
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Image /page/5/Picture/1 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 people in green, blue, and gray. Below the logo is the company's address, which includes a series of numbers, followed by "Digital-ro 34-gil, Guro-gu, Seoul, 08378, Korea". The image also includes the telephone and fax numbers for the company, both of which are +82 2 850 3533 and +82 2 850 3536 respectively.
#### 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 o
- 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 Clavicle 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 (K130116), the ARIX Clavicle System presented in this submission has equivalent:
- · Indication for Use
- · Technological characteristics
- · Operating principle
- · Design features
- · Performance
- · Materials
- Method of sterilization
## 9. Conclusion [21 CFR 807.92(b)(3)]
In all respects, the ARIX Clavicle System is the equivalent of currently marketed devices. This device is made of same materials and has similar dimensions and characteristics. The ARIX Clavicle System is manufactured from titanium alloy that is used generally in this kind of bone plate and bone screw system. Based on the information submitted, ARIX Clavicle System is substantially equivalent to the currently marketed predicate devices.
