(96 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and equivalence to predicate devices, with no mention of AI or ML.
Yes.
The device is used for internal fixation of bones, which is a therapeutic intervention to treat conditions like fractures and promote healing.
No
The device, ARIX Hand Locking System, is described as a rigid fixation system (plates and screws) for internal fixation of bones, which is a therapeutic function, not diagnostic.
No
The device description explicitly states it is a rigid fixation system consisting of plates and screws made of titanium, along with manual surgical instruments. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "internal fixation of the bones of hand and wrist." This is a surgical procedure performed directly on the patient's body to stabilize bones.
- Device Description: The device consists of "plates and screws" and "manual surgical instruments." These are physical implants and tools used during surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition, monitor a treatment, or screen for diseases.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens for diagnostic purposes. The ARIX Hand Locking System is an implantable surgical device used in vivo (inside the body) for structural support.
N/A
Intended Use / Indications for Use
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.
Product codes
HRS
Device Description
The ARIX Hand Locking System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes as follow;
Plate Type/Configuration: F2L-Series, Material: ASTM F 67 Pure Titanium
Cortical Screw Type/Configuration: 20-HF-Series, Material: ASTM F 136 Titanium Alloy (Ti-6Al-4V)
Locking Screw Type/Configuration: 20L-HF-Series, Material: ASTM F 136 Titanium Alloy (Ti-6Al-4V)
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 10-6 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand and wrist bones
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital
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 proposed device met all design specifications. The test results demonstrated that the proposed device complies with ASTM F 382-99, Standard Specification and Test Method for Metallic Bone Plates, and ASTM F 543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws. The following tests were performed:
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.
The results of this testing indicate that the ARIX Hand Locking System is equivalent to predicate devices. No clinical studies were considered necessary and performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
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 .
1
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 | |
|---|---|---|---|
| Type | |||
| Configuration | F2L-Series | 20-HF-Series | 20L-HF-Series |
| Material | ASTM F 67 | ||
| Pure Titanium | ASTM F 136 | ||
| Titanium Alloy | |||
| (Ti-6Al-4V) | ASTM F 136 | ||
| Titanium Alloy | |||
| (Ti-6Al-4V) |
2
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)]
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.
3
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.
4
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
5
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
6
Indication for Use
510(k) Number (if known): K132876
Device Name: ARIX Hand Locking System
Indication for Use:
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.
× 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