(54 days)
No
The device description and performance studies focus on the mechanical properties and materials of bone plates and screws, with no mention of AI or ML capabilities.
Yes.
The device is intended for the fixation of fractures, nonunions, replantations, and fusions, which are therapeutic medical interventions.
No
The device is a system of bone plates and screws intended for the fixation of fractures and similar conditions; it is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is composed of locking bone plates and locking screws made of titanium, which are physical hardware components.
Based on the provided information, the ARIX Small Fragment System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the fixation of fractures, nonunions, replantations, and fusions of small bones and bone fragments. This is a surgical implant used directly on the patient's body.
- Device Description: The device is described as locking bone plates and screws made of titanium. These are physical implants.
- 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 about a patient's health. IVD devices are used for diagnosis, monitoring, or screening based on in vitro analysis.
The ARIX Small Fragment System is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The ARIX Small Fragment System is intended for fixation of fractures, nonumons, replantations, and fusions pf small bones and small bone fragments. Examples include, but are not limited to, the hand, wrist, foot, and ankle.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The ARIX Small Fragment System is composed locking bone plate and locking screws that provide rigid fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments. Examples include, but are not limited to, the hand, wrist, foot, and ankle.
The ARIX Small Fragment System is made of Unalloyed Titanium and Titanium Alloy (Ti-6A1-V), 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 bone plates consist of Straight, Triangle and T type which has different lengths and number of plate holes. The bone screws are compatible with K201656 ARIX Elbow System Bone Screw previously cleared. The screws are 2.8mm in diameter with self-tapping and provided with lengths from 8.0 to 70.0mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand, wrist, foot, and ankle
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 subject device met all design specifications. The test result demonstrated that the subject device complies with the following standards:
- ASTM F382, Standard Specification and Test Method for Metallic Bone Plates
- ASTM F543, Standard Specification and Test Method for Metallic Medical Bone Screws .
The results of this testing indicate that the ARIX Small Fragment 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): 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.
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
August 24, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Jeil Medical Corporation Bora Kim RA Specialist 702, 703, 704, 705, 706, 804, 805, 807, 812, 815-ho 55, Digital-ro 34-gil, Guro-gu Seoul, 08378 South Korea
Re: K221920
Trade/Device Name: ARIX Small Fragment 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: June 30, 2022 Received: July 1, 2022
Dear Bora Kim:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 08/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name
ARIX Small Fragment System
Indications for Use (Describe)
The ARIX Small Fragment System is intended for fixation of fractures, nonumons, replantations, and fusions pf small bones and small bone fragments. Examples include, but are not limited to, the hand, wrist, foot, and ankle.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (6/20)
Page 1 of 1
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510(k) Summary
[As required by 21 CRF 807.92]
1. Date Prepared [21 CRF 807.92(a)(a)|
June 30, 2022
2. Submitter's Information [21 CFR 807.92(a)(1)]
- . Name of Sponsor: Jeil Medical Corporation 702,703,704,705,706,804,805,807,812,815-ho, 55, . Address: Digital-ro 34-gil, Guro-gu, Seoul, 08378, Korea
- Contact Name: Bora Kim / RA Specialist
- Telephone No.: +82 2 850 3533 ●
- Fax No.: +82 2 850 3536 ●
- . Email Address: borakim@jeilmed.co.kr
- Telephone No.: +82 2 850 3533 ●
- Registration Number: 3004049923
- . Name of Manufacturer: Same of Sponsor . Same of Sponsor Address:
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name; | ARIX Small Fragment System |
|---|---|
| Common Name; | Bone Plate and Bone Screw |
| Classification Name; | Plate, Fixation, Bone / Screw, Fixation, Bone |
| Classification Panel; | Orthopedic |
| Classification Regulation; | 21 CFR 888.3030 |
| Product Code; | HRS(Primary), HWC |
| Device Class; | II |
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)|
The legally marketed device(s) to which substantial equivalence is claimed is/are:
| Predicate Device | K063049 – Synthes Modular Mini Fragment LCP System |
|---|---|
| Reference Device | K201656 – ARIX Elbow System, Jeil Medical Corporation |
There are no significant differences between the subject device and the predicate devices that would
4
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 Small Fragment System is composed locking bone plate and locking screws that provide rigid fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments. Examples include, but are not limited to, the hand, wrist, foot, and ankle.
The ARIX Small Fragment System is made of Unalloyed Titanium and Titanium Alloy (Ti-6A1-V), 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 bone plates consist of Straight, Triangle and T type which has different lengths and number of plate holes. The bone screws are compatible with K201656 ARIX Elbow System Bone Screw previously cleared. The screws are 2.8mm in diameter with self-tapping and provided with lengths from 8.0 to 70.0mm.
6. Indication for Use [21 CFR 807.92(a)(5)]
The ARIX Small Fragment System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments. Examples include, but are not limited to, the hand, wrist, foot, and ankle.
7. Technological Characteristics [21 CFR807.92(a)(6)]
Bone Plate: Based on a technical feature comparison, the subject device was found to be similar to all predicate device with regard to design and materials. The subject plates also have a variable locking feature, similar to the design used in the predicate device (K063049).
Bone Screw: ARIX Small Fragment Bone Screws consist of the previously cleared "ARIX Elbow System(K201656).
Non-Clinical Test Summary:
Bench tests were conducted to verify that the subject device met all design specifications. The test result demonstrated that the subject device complies with the following standards:
- ASTM F382, Standard Specification and Test Method for Metallic Bone Plates
- ASTM F543, Standard Specification and Test Method for Metallic Medical Bone Screws .
The results of this testing indicate that the ARIX Small Fragment System is equivalent to predicate device.
Clinical Test Summary:
No clinical studies were considered necessary and performed.
5
8. Substantial Equivalence [21 CFR 807.92(b)(3)|
When compared to the predicate device (K063049), the ARIX Small Fragment System presented in this submission has equivalent:
- Indication for Use -
- -Technological characteristics
- Operating principle -
- Design features -
- -Performance
- Biocompatibility -
- Materials -
- Method of sterilization. -
Conclusion [21 CFR 807.92(b)(3)] 9.
In all respects, the ARIX Small Fragment System is substantially equivalent to the legally marketed device (K063049). The subject device has similar indications for use as the predicate device and has similar dimension and technical characteristics. Bench testing demonstrated equivalent mechanical performance. It is therefore concluded that the subject devices are considered substantially equivalent to the predicate devices.