(197 days)
No
The device description and performance studies focus on the mechanical properties and equivalence to predicate devices, with no mention of AI/ML, image processing, or data sets typically associated with such technologies.
Yes
The device is intended for use in treating forearm fractures, osteotomies, and arthrodeses, which are conditions requiring medical intervention to restore function or correct anatomical deformities.
No
The device description and intended use clearly state that it is an implant system (plates, screws, and surgical instruments) used for treating fractures, osteotomies, and arthrodesis, which are therapeutic rather than diagnostic purposes.
No
The device description explicitly states it consists of physical plates, screws, and surgical instruments made of titanium, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "forearm fractures, osteotomies and arthrodesis" and "fractures and osteotomies, in particular for the ulna." These are surgical procedures performed directly on the patient's body.
- Device Description: The description details plates, screws, and surgical instruments made of titanium. These are all components used in surgical implantation and bone fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body. This device is a surgical implant and associated instruments used within the body for structural support and fixation.
N/A
Intended Use / Indications for Use
The ARIX Wrist System(Radius) is intended for use in forearm fractures, osteotomies and arthrodesis. The ARIX Wrist System(Ulna) is intended for fractures and osteotomies, in particular for the ulna.
Product codes
HRS, HWC
Device Description
The ARIX Wrist System consists of plates designed for the Ulna and Radius. The ARIX Wrist 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-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 vary essentially through different lengths and diameters. The screws in this system are available from 2.0mm to 2.8mm. It also includes various manual surgical instruments, as drill guides, drill bits, driver shafts, depth gauge, bender and hand body. The ARIX Wrist System not provided sterile. It is required to be sterilized via autoclave using the validated method prior to surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forearm (Radius and Ulna)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests were conducted to verify that the proposed device had substantially equivalent performance compared to a predicate. The test results demonstrated that the proposed device complies with the following standards:
- . Plate
- ASTM F 382, Standard Specification and Test Method for Metallic Bone Plates
- . Screw
- ASTM F 543, Standard Specification and Test Methods for Metallic Medical Bone Screws -
The following tests were performed with the predicate device:
- . Plate
- Dimension test per ASTM F382
- 4-Point Bending test per ASTM F382 -
- Fatigue test per ASTM F382
- Screw
- Dimension test per ASTM F543 -
- Driving torque test per ASTM F543 -
- Axial pull-out test per ASTM F543 -
- Torsion test per ASTM F543 i
The results of this testing indicate that the ARIX Wrist System is equivalent to predicate device.
No clinical studies were considered necessary and performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
September 21, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Jeil Medical Corporation Jiwon Song RA Specialist #702. Kolon Science Vallev 2nd 55, Digital-ro 34, Guro-gu Seoul, 152-728 KR
Re: K170705
Trade/Device Name: ARIX Wrist 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 7, 2017 Received: September 8, 2017
Dear Ji Song:
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
Image /page/0/Picture/10 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 an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.
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 (DICE) 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 (DICE) 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 and contact information for JEIL MEDICAL CORPORATION. The logo features a stylized smiling face with different colored segments, followed by the company name in a bold, sans-serif font. Below the logo is the address: 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, 152-728, Korea. The telephone and fax numbers are also listed as: Tel: +82 2 850 3533 / Fax: +82 2 850 3535.
Indication for Use
510(k) Number (if known): K170705
Device Name: ARIX Wrist System
Indication for Use:
The ARIX Wrist System(Radius) is intended for use in forearm fractures, osteotomies and arthrodesis. The ARIX Wrist System(Ulna) is intended for fractures and osteotomies, in particular for the ulna.
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)
3
Image /page/3/Picture/1 description: The image shows 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, 152-728, Korea. The phone number is Tel: +82 2 850 3533 and the fax number is Fax: +82 2 850 3535.
510(k) Summary
[As required by 21 CRF 807.92]
Date Prepared [21 CRF 807.92(a)(a)] 1.
March 06. 2017
2. Submitter's Information [21 CFR 807.92(a)(1)]
- Jeil Medical Corporation Name of Sponsor: . #702, Kolon Science Valley 2nd Address: -55, Digital-ro 34, Guro-gu Seoul, 152-728, Korea-
- Contact Name: Jiwon Song / RA Specialist Telephone No. : +82 2 850 3587 --Fax No. : +82 2 850 3525 Email Address : sjw@jeilmed.co.kr -
- 3004049923 ● Registration Number: Name of Manufacturer: . Same as Sponsor -Address: Same as Sponsor
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
- ARIX Wrist System ● Trade Name: ● Common Name: Bone Plate and Screw . Classification Name: Plate, Fixation, Bone / Screw, Fixation, Bone ● Classification Description: Single/multiple component metallic bone fixation appliances and accessories Smooth or threaded metallic bone fixation fastener . Classification Panel: Orthopedic ● Classification Regulation: 21 CFR 888.3030 21 CFR 888.3040 ● Product Code: HRS / HWC ● Device Class: ll
Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[ 4.
The identified predicate devices within this submission are shown as follow;
| ● | 510(k) Number: | K151468 |
|---|---|---|
| ● | Applicant: | Jeil Medical Corporation |
| ● | Device Name: | ARIX Wrist System |
4
Image /page/4/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, 152-728, Korea. The telephone number is +82 2 850 3533 and the fax number is +82 2 850 3535.
- . 510(k) Number: K092247
- Applicant: Synthes
- Device Name: Synthes Locking Hand Plates ●
- 510(k) Number: K102694
- . Applicant: Synthes
- Device Name: Synthes 2.4mm Variable Angle LCP Dorsal Distal Radius Plates ●
There are no significant differences between the subject system and the predicate devices (K151468, K092247, K102694) in design, function, materials, and operational principles as internal fixation components.
- Reference Predicate Devices
| • 510(k) Number: | K112812 |
|---|---|
| • Device Name: | LeForte System |
- 510(k) Number: K131311 ● ● Device Name: ARIX Foot System
- 510(k) Number: . K132876
- . Device Name: ARIX Hand Locking System
Description of the Device [21 CFR 807.92(a)(4)] 5.
The ARIX Wrist System consists of plates designed for the Ulna and Radius. The ARIX Wrist 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-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 vary essentially through different lengths and diameters. The screws in this system are available from 2.0mm to 2.8mm. It also includes various manual surgical instruments, as drill guides, drill bits, driver shafts, depth gauge, bender and hand body. The ARIX Wrist System not provided sterile. It is required to be sterilized via autoclave using the validated method prior to surgery.
Indication for Use [21 CFR 807.92(a)(5)] 6.
The ARIX Wrist System(Radius) is intended for use in forearm fractures, osteotomies and arthrodesis. The ARIX Wrist System(Ulna) is intended for fractures and osteotomies, in particular for the ulna.
Technological Characteristics [21 CFR 807.92(a)(6)] 7.
ARIX Wrist 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 poly axial locking feature, similar to the design used in the predicate devices (K151468, K090047, K102694).
5
Image /page/5/Picture/1 description: The image shows 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, 152-728, Korea. The telephone number is +82 2 850 3533 and the fax number is +82 2 850 3535.
ARIX Wrist System, Bone Screws: They share similar head, neck and thread designs with predicate devices (K151468).
Non-Clinical Test Summary:
Bench tests were conducted to verify that the proposed device had substantially equivalent performance compared to a predicate. The test results demonstrated that the proposed device complies with the following standards:
- . Plate
- ASTM F 382, Standard Specification and Test Method for Metallic Bone Plates
- . Screw
- ASTM F 543, Standard Specification and Test Methods for Metallic Medical Bone Screws -
The following tests were performed with the predicate device:
- . Plate
- Dimension test per ASTM F382
- 4-Point Bending test per ASTM F382 -
- Fatigue test per ASTM F382
- Screw
- Dimension test per ASTM F543 -
- Driving torque test per ASTM F543 -
- Axial pull-out test per ASTM F543 -
- Torsion test per ASTM F543 i
The results of this testing indicate that the ARIX Wrist System is equivalent to predicate device.
Clinical Test Summary:
No clinical studies were considered necessary and performed.
Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92] 8.
The subject device has the same device characteristics as our previously cleared predicate device. They have the same intended use, raw material, and use concept and employ the same anodization and sterilization method. The differences are in shape and dimensions; however; the performance test data provided in this submission proves the subject device is safe and effective and performed substantially equivalent to the predicates.
9. Conclusion [21 CFR 807.92(b)(3)]
Based on the information provided in this premarket notification Jeil Medical Corporation concludes that ARIX Wrist System Bone Plate & Screw is as safe and as effective as the predicate devices.