(227 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 described as rigid fixation plates and screws intended for use in forearm fractures, osteotomies, and arthrodeses, which are medical treatments for healing or correcting bone conditions.
No
The ARIX Wrist System is described as rigid fixation plates and screws intended for use in forearm fractures, osteotomies, and arthrodeses. It is a surgical implant device, not a diagnostic tool.
No
The device description explicitly states it consists of rigid fixation plates and screws made of titanium, along with various manual surgical instruments. This indicates a physical hardware device, not software only.
No, 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 device is described as "rigid fixation plates and screws" made of titanium. These are implants used to stabilize bones.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Anatomical Site: The anatomical sites listed (Forearm, Radius, Ulna, Wrist) are all parts of the human musculoskeletal system where surgical intervention occurs.
- Performance Studies: The performance studies described are bench tests evaluating the mechanical properties of the plates and screws (bending, fatigue, torque, pull-out, torsion). These are relevant to the structural integrity of a surgical implant, not a diagnostic test.
IVD devices are used in vitro (outside the body) to examine specimens from the human body. This device is used in vivo (inside the body) as a surgical implant.
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 (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The ARIX Wrist System is consists of the Radius & Ulna. It is rigid fixation plates and screws which were recommended combination as follow;
Plate Type / Configuration: Radius (25-DVRA Series), Ulna (25-DLUL Series)
Screw Type: Self-tapping Cortical Screw (25-HF Series), Self-tapping Locking Screw (161.0325 Series for Radius, 25L-HF Series for Ulna)
Material:
Plate: ASTM F 67 Pure Titanium
Self-tapping Cortical Screw: ASTM F 136 Titanium Alloy (Ti-6Al-4V)
Self-tapping Locking Screw: ASTM F 136 Titanium Alloy (Ti-6Al-4V)
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-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which h are widely used for surgical implants with well-known biocompatibility. The plates vary essentially through different lengths and number of plate holes. The self-tapping cortical screws & self-tapping locking screws diameter is 2.5mm and lengths is from 8mm to 38mm. It also includes various manual surgical instruments, as drill guides, drill bits, driver shafts, depth gauge, bender and handbody etc,. The ARIX Wrist 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forearm fractures, osteotomies and arthrodesis (Radius), fractures and osteotomies, in particular for the ulna (Ulna)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 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
- Single Cycle Bending test per ASTM F382
- Bending Fatigue 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 Wrist System is equivalent to predicate devices.
No clinical studies were considered necessary and performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
January 14, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Jeil Medical Corporation Sejin Ryu Regulatory Affairs Specialist. Ouality Management Department 702 · 703 · 704 · 705 · 706 · 804 · 805 · 807 · 812-ho, 55, Digital-ro34-gil, Guro-gu, Seoul, 152-728 KOREA
Re: K151468 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: December 7, 2015 Received: December 10, 2015
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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 (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" (21CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name ARIX Wrist System
Indications for Use (Describe)
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.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/0 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 3500 and the fax number is Fax: +82 2 850 3535.
510(k) Summary
[As required by 21 CRF 807.92]
1. Date Prepared [21 CRF 807.92(a)(a)]
14 January, 2016
2. Submitter's Information [21 CFR 807.92(a)(1)]
- . Name of Sponsor: Jeil Medical Corporation
- 702·703·704·705·706·804·805·807·812-ho, 55 i Address: Digital-ro34-gil, Guro-gu, Seoul, 152-728, Korea
- Sejin RYU (Ms.) / RA Specialist . Contact Name:
| - | Telephone No. : | +82 2 850 3500 |
|---|---|---|
| - | Fax No. : | +82 2 850 3525 |
| - | Email Address : | rsj@jeilmed.co.kr |
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 Wrist System |
|---|---|
| Common Name: | Bone plates and screws |
| Classification Name: | |
| appliances and accessories | Single/multiple component metallic bone fixation |
| Classification Panel: | Orthopedic |
| Classification Regulation: | 21 CFR 888.3030, 21 CFR 888.3040 |
| Product Code: | HRS, HWC |
| Device Class: | II |
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Image /page/4/Picture/0 description: The image shows the logo for JEIL MEDICAL CORPORATION. Below the logo is the address: 702-703-704-705-706-804-805-807-ho, 55, Digital-ro34-gil, Guro-gu, 152-728, Korea. The phone number is +82 2 850 3500 and the fax number is +82 2 850 3535.
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: | K103332 |
|---|---|
| • Applicant: | Medartis AG |
| • Common Name: | plate, fixation, bone |
- Device Name: APTUS® Ulna Plates .
| ● | 510(k) Number: | K142906 |
|---|---|---|
| ● | Applicant: | Medartis |
| ● | Common Name: | Plate, fixation, bone |
| Screw, Fixation, Bone | ||
| ● | Device Name: | APTUS® Wrist 2.5 System |
There are no significant differences between the Model ARIX Wrist 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.
Description of the Device [21 CFR 807.92(a)(4)] 5.
The ARIX Wrist System is consists of the Radius & Ulna. It is rigid fixation plates and screws which were recommended combination as follow;
| Type /
| Configuration | Plate | Screw | |
|---|---|---|---|
| Self-tapping | |||
| Cortical Screw | Self-tapping | ||
| Locking Screw | |||
| Radius | 25-DVRA Series | 25-HF Series | 161.0325 Series |
| Ulna | 25-DLUL Series | 25-HF Series | 25L-HF Series |
| Material | ASTM F 67 | ||
| Pure Titanium | ASTM F 136 | ||
| Titanium Alloy | |||
| (Ti-6Al-4V) | ASTM F 136 | ||
| Titanium Alloy | |||
| (Ti-6Al-4V) |
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-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which h are widely used for surgical implants with well-known biocompatibility. The plates vary essentially through different lengths and number of plate holes. The self-tapping cortical screws & self-tapping locking screws diameter is 2.5mm and lengths is from 8mm to 38mm. It also includes various manual surgical instruments, as drill guides, drill bits, driver shafts, depth gauge, bender and
5
Image /page/5/Picture/0 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 logo has the word JEIL in orange and MEDICAL CORPORATION in gray.
Tel : +82 2 850 3500 / Fax : +82 2 850 3535 handbody etc,. The ARIX Wrist 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.
6. Intended Use [21 CFR 807.92(a)(5)]
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.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
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 (K103332/ K142906).
ARIX Wrist System, Bone Screws: They share similar head, neck and thread designs as the smaller screws that are currently cleared under the predicate devices (K142906).
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 ı
- Single Cycle Bending test per ASTM F382 l
- Bending Fatigue 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 Wrist System is equivalent to predicate devices.
Clinical Test Summary:
No clinical studies were considered necessary and performed.
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Image /page/6/Picture/0 description: The image shows the logo and contact information for JEIL MEDICAL CORPORATION. The logo features a stylized smiley face in green, orange, and gray, followed by the company name in gray 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, 152-728, Korea. The telephone number is +82 2 850 3500 and the fax number is +82 2 850 3535.
8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]
When compared to the predicate devices (K103332/ K142906), the ARIX Wrist System presented in this submission has the same;
- Intended Use ●
- Technological characteristics ●
- Operating principle ●
- Design features ●
- Performance .
- Biocompatibility .
- Materials
- Method of sterilization and sterility assurance level ●
Conclusion [21 CFR 807.92(b)(3)] 9.
In all the respects, the ARIX Wrist 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 material of the Pure Titanium and Titanium Alloy, Unalloyed titanium and Wrought titanium alloy that is used generally in this kind of bone plate/screw system. This device, ARIX Wrist System, is substantially equivalent in design, material, and function to the predicate devices.