The ARIX Hand Locking System is intended for use in internal fixation of the bones of hand and wrist. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.

Device Description

The ARIX Hand Locking System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Hand Locking 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 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. The plates vary essentially through different lengths and number of plate holes. The cortical screws & locking screws diameter is 2.0mm and lengths is from 6mm to 30mm. It also includes various manual surgical instruments, as drill quides, drill bits, driver shafts, depth gauge, bender and handbody. The ARIX Hand Locking System is not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10° by the hospital prior to surgery.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ARIX Hand Locking System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance (Test Results)
ASTM F 382-99 (Metallic Bone Plates, includes Tensile strength, Bending strength)	Complies
ASTM F 543-07 (Metallic Medical Bone Screws, includes Driving torque, Axial pull-out, Torsion)	Complies
Design specifications (presumably internal to Jeil Medical)	Met all design specifications
Dimensional tests (Plates & Screws)	Complies

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a 'test set' in the context of clinical data for the device. The testing described is bench testing only. Therefore, the sample sizes refer to the number of plates and screws tested in vitro according to the specified ASTM standards. The exact number of samples for each specific test (e.g., number of plates for tensile strength, number of screws for driving torque) is not provided in the document.

Test Set Sample Size: Not explicitly stated for specific tests; implied to be sufficient for compliance with ASTM standards.
Data Provenance: Not applicable as no clinical human data was used. The data comes from in vitro bench testing conducted presumably by Jeil Medical Corporation or a contracted lab.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. No ground truth was established by human experts for a test set, as no clinical studies were performed. The "ground truth" for compliance was defined by the ASTM standards and design specifications.

4. Adjudication Method for the Test Set

Not applicable. No human adjudication was involved as no clinical studies were performed. The compliance was determined by objective measurements against established engineering standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The document explicitly states: "No clinical studies were considered necessary and performed."

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical bone fixation system, not a software algorithm or AI-driven tool. Therefore, a "standalone algorithm performance" study is not relevant.

7. Type of Ground Truth Used

The ground truth used was objective engineering standards (ASTM F 382-99 and ASTM F 543-07) and the manufacturer's own design specifications for the physical properties and performance of the plates and screws.

8. Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is a physical medical device, not an AI or algorithm-driven system that requires training data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set.

Summary

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DEC 1 8 2013

K132876 Page 1/4

O JEIL MEDICAL

#702, Kolon Science Valley 200, 811 Guro-Dong, Guro-Gu, Seoul, 152-050 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)]

10 September 2013

2. Submitter's Information [21 CFR 807.92(a)(1)]

Name of Sponsor:	Jeil Medical Corporation
------------------	--------------------------

Address: #702, Kolon Science Valley 2nd -811, Guro-dong, Guro-gu Seoul, 152-050, Korea
Hyeroung LEE (Ms.) / RA Manager Contact Name: .
- Telephone No. : +82 2 850 3500 .
- +82 2 850 3525 Fax No. : --
- Email Address : carine@jeilmed.co.kr
3004049923 Registration Number: .
Name of Manufacturer: Same as Sponsor .
- Address: Same as Sponsor ー

Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] 3.

Trade Name: ARIX Hand Locking 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 .

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K132876 Page 2/4

Image /page/1/Picture/1 description: The image shows the logo for JEIL MEDICAL CORPORATION. The logo consists of a stylized graphic to the left of the text "JEIL MEDICAL" with "CORPORATION" in smaller font below "MEDICAL". The graphic appears to be a stylized representation of a medical device or symbol.

#702, Kolon Science Valley 200, 811 Guro-Dong, Guro-Gu, Seoul, 152-050 Korea Tel : +82 2 850 3500 / Fax : +82 2 850 3535

Product Code: HRS .
. Device Class: 11

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: K062498 .
Applicant: Howmedica Osteonics Corp. .

Common Name: .

Bone plates and screws

Profyle® System Device Name: .

510(k) Number:	K023360
Applicant:	Jeil Medical Corpoation
Common Name:	Bone plates and screws

Device Name: Leforte System Bone Plate .
510(k) Number: K023365 .
Applicant: .
Common Name: .
Device Name: .

Jeil Medical Corpoation Bone plates and screws Leforte System Bone Screw

There are no significant differences between the Model ARIX Hand Locking 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 Hand Locking System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes as follow;

	Plate	Cortical Screw	Locking Screw
TypeConfiguration	F2L-Series	20-HF-Series	20L-HF-Series
Material	ASTM F 67Pure Titanium	ASTM F 136Titanium Alloy(Ti-6Al-4V)	ASTM F 136Titanium Alloy(Ti-6Al-4V)

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K132876 Page 3/4

"A JEIL MEDICAL

#702, Kolon Science Valley 200, 811 Guro-Dong, Guro-Gu, Seoul, 152-050 Korea Tel : +82 2 850 3500 / Fax : +82 2 850 3535

The ARIX Hand Locking 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 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 2.0mm and lengths is from 6mm to 30mm. It also includes various manual surgical instruments, as drill quides, drill bits, driver shafts, depth gauge, bender and handbody. The ARIX Hand Locking System is 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.

6. Intended Use [21 CFR 807.92(a)(5)]

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K132876 Page 4/4

Image /page/3/Picture/1 description: The image shows the logo for JEIL MEDICAL CORPORATION. The logo consists of a stylized graphic to the left of the text. The text is in a simple, sans-serif font, with "MEDICAL" stacked above "CORPORATION."

811 702. Kolon Science Valley 2 Guro-Dong, Guro-Gu, Seoul, 152-050 Korea Tel : +82 2 850 3500 / Fax : +82 2 850 3535

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

ARIX Hand Locking 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 polyxial locking feature, similar to the design used in the predicate devices (K062498, K023360).

ARIX Hand Locking System, Bone Screws: They share similar head, neck and thread designs as the smaller screws that are currently cleared under the predicate devices (K062498, K023365).

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 . Screws

The following tests were performed with the predicate devices:

Plates .
- Dimension test
- Tensile strength test -
- Bending strength 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 ー

The results of this testing indicate that the ARIX Hand Locking System is equivalent to predicate devices.

Clinical Test Summary:

No clinical studies were considered necessary and performed.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 18, 2013

Jeil Medical Corporation Ms. Hyeroung Lee Regulatory Affairs Manager #702, Kolon Science Valley 2nd 811, Guro-dong, Guro-gu Seoul 152-050 Republic of Korea

Re: K132876

Trade/Device Name: ARIX Hand Locking 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: September 24, 2013 Received: September 25, 2013

Dear Ms. 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 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

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Page 2 -- Ms. Hyeroung Lee

CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometries/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Ronald P. Jean -S for

Mark N. Melkerson Director Division of Orthopedie Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known): K132876

Device Name: ARIX Hand Locking System

Indication for Use:

× 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)

Page 1 of 1

Elizabeth L. Frank -S

Division of Orthopedic Devices

Regulation Number and Section

§ 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.