ARIX Ankle Fibula Hook Plate System

K170979 · Jeil Medical Corporation · HRS · Aug 17, 2017 · Orthopedic

Device Facts

• Record ID: K170979
• Device Name: ARIX Ankle Fibula Hook Plate System
• Applicant: Jeil Medical Corporation
• Product Code: HRS · Orthopedic
• Decision Date: Aug 17, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ARIX Ankle Fibula Hook Plate System is intended for use in internal fixation of the distal fibula.

Device Story

The ARIX Ankle Fibula Hook Plate System is a rigid internal fixation device used by orthopedic surgeons in clinical settings. It consists of titanium plates in various configurations, lengths, and hole counts, designed to stabilize the distal fibula. The system includes manual surgical instruments such as drill bits, countersinks, depth gauges, drill guides, drill sleeves, guide pins, benders, and screwdriver handles. The plates feature both locking and non-locking holes to accommodate 3.5mm cortex and locking screws. The device is provided non-sterile and must be autoclaved by the hospital prior to use. By providing rigid fixation, the system supports bone healing and structural stability for the patient.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by engineering analysis and bench testing, including bending strength and fatigue testing per ASTM F382.

Technological Characteristics

Constructed from Pure Titanium Gr4 (ASTM F67). Features locking and non-locking plate holes for 3.5mm screws. Mechanical performance validated per ASTM F382. Sterilization via moist heat (autoclave) validated per ISO 17665-1:2006 to achieve SAL 10^-6.

Indications for Use

Indicated for internal fixation of the distal fibula in patients requiring bone stabilization.

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

• ARIX Ankle System (K152158)
• VariAx Distal Fibula Plate (K081284)

Submission Summary (Full Text)

{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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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 #702.703.704.705.706.804.805.807.812-ho.55 Digital-ro34-gil, Guro-gu, Seoul, 152-728 Korea

August 17, 2017

Re: K170979 Trade/Device Name: ARIX Ankle Fibula Hook Plate 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 Dated: July 21, 2017 Received: July 21, 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 [phone] or [phone] 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 [phone] or [phone] 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/1 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, Seoul, 152-728, Korea. The telephone number is [phone], and the fax number is [phone].

## Indications for Use

510(k) Number (if known):

Device Name: ARIX Ankle Fibula Hook Plate System

Indications for Use:

The ARIX Ankle Fibula Hook Plate System is intended for use in internal fixation of the distal fibula.

Prescription Use × (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/1 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 igital-ro34-gil, Guro-gu, Seoul, 152-728, Korea. The phone number is [phone] and the fax number is [phone].

# 510(k) Summary

[As required by 21 CFR 807.92]

#### 1. Date Prepared [21 CFR 807.92(a)(1)]

16 August, 2017

#### 2. Submitter's Information [21 CFR807.92(a)(1)]

- Name of Sponsor: Jeil Medical Corporation .
- 702·703·704·705·706·804·805·807·812-ho,55 -Address: Digital-ro34-gil, Guro-qu, Seoul, 152-728, Korea
- . Contact Name: Sejin RYU / RA Specialist
- Telephone No. : — [phone]
- । Fax No. : 482 2 850 3536
- Email Address : [e-mail] |
- 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 Fibula Hook Plate System |
|---|----------------------------|--------------------------------------------------------------------------------|
| ● | Common Name: | Bone plates |
| ● | Classification Name: | Single/Multiple Component Metallic Bone Fixation<br>Appliances and Accessories |
| ● | Classification Panel: | Orthopedic |
| ● | Classification Regulation: | 21 CFR 880.3030 |
| ● | Product Code: | HRS |
| ● | Device Class: | II |

{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 the company name in orange text. Below the logo is the company's address: 702-703-704-705-706-804-805-807-812-ho,55 Digital-ro34-gil, Guro-gu, Seoul, 152-728, Korea. The phone number is [phone] and the fax number is [phone].

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

The identified predicate devices within this submission are shown as follows:

K152158

- 510(k) Number: ●
- Applicant: ●
- Jeil Medical Cororation Common Name: Plate, Fixation, Bone
- Device Name: ARIX Ankle System ●
- 510(k) Number:
- Applicant: ●

●

K081284 Howmedica Osteonics Corp.

- Common Name: Plate, Fixation, Bone
- Device Name: VariAx Distal Finula Plate ●

There are no significant differences between the Model ARIX Ankle Fibula Hook Plate 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 Fibula Hook Plate System is rigid fixation consisting of plates in various configurations, shapes and sizes, as follows:

| | Plate |
|---------------------|-----------------------------|
| Type/ Configuration | Hook Plate |
| Material | ASTM F67, Pure Titanium Gr4 |

The ARIX Ankle Fibula Hook Plate System is made of Pure Titanium Gr4 which meets ASTM F67, Standard Specification for Unalloyed Titanium, 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 plate features locking holes and non-locking holes which accept 3.5mm cortex screws and locking screw. (Previously cleared K152158, K161864)

It also includes various manual surgical instruments, such as drill bits, counter sink, depth gauge, compression, drill guide, drill sleeve, guide pin, bender and screw driver handle.

ARIX Ankle Fibula Hook Plate 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.

{5}------------------------------------------------

Image /page/5/Picture/1 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, Seoul, 152-728, Korea. The phone number is Tel: [phone] and the fax number is Fax: [phone].

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

The ARIX Ankle Fibula Hook Plate System is intended for use in internal fixation of the distal fibula.

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

ARIX Ankle Fibula Hook Plate: 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 (K152158, K081284).

#### Non-Clinical Test Summary:

An engineering analysis was performed to evaluate the engineering rationale of predicate compared to the subiect device plate.

The test results demonstrated that the proposed device complies with the following standards:

- o ASTM F 382, Standard Specification and Test Method for Metallic Bone Plates
The following tests were performed with the predicate device:

- . Plates
- Bending strength test per ASTM F382 ।
- Bending fatigue test per ASTM F382 ।

The engineering rationale indicates that the ARIX Ankle Fibula Hook Plate System is equivalent to the 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 (K152158, K081284) the ARIX Ankle Fibula Hook Plate System presented in this submission has the same:

- Intended Use
- Technological characteristics ●
- Operating principle
- Design features
- . Performance
- Biocompatibility
- Materials
- o Method of sterilization and sterility assurance level

{6}------------------------------------------------

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

In all respects, the ARIX Ankle Fibula Hook Plate 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 Fibula Hooke Plate System, is substantially equivalent in design, material, and function to the predicate device.