(30 days)
Not Found
No
The device description focuses on the physical components (plates, screws, instruments) and materials, with no mention of software, algorithms, or AI/ML capabilities. The performance studies are bench tests for mechanical properties, not algorithmic performance.
No
The device is described as rigid fixation consisting of plates and screws for humerus fractures, designed for mechanical support rather than directly treating a disease or condition therapeutically.
No
Explanation: The device is a system of plates and screws used for rigid fixation of fractures, osteotomies, and non-unions of the proximal humerus. It is a treatment device, not one that identifies or determines a medical condition.
No
The device description explicitly states it consists of physical components (plates, screws, surgical instruments) made of titanium, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the surgical fixation of fractures, osteotomies, and non-unions of the proximal humerus. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device consists of plates, screws, and surgical instruments. These are physical implants and tools used in surgery, not reagents, instruments, or software used to examine in vitro samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on in vitro testing.
The ARIX Humerus System is a surgical implant system used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The ARIX Humerus System is indicated for fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone.
Product codes
HRS, HWC
Device Description
The ARIX Humerus System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes.
The ARIX Humerus System is consists of plates and screws. The ARIX Humerus 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 screws vary essentially through different lengths and diameters. It also includes various manual surgical instruments, as drill bits, driver shafts, depth gauge.
The ARIX Humerus System is not provided sterile. It is required to reach a SAL of 106 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
proximal humerus
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
Bench tests were conducted to verify that the proposed device met all design specifications. The test results 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 Methods for Metallic Medical Bone Screws
The following tests were performed with the predicate device:
- Plate
- Bending strength test per ASTM F382
- Bending fatigue test per ASTM F382
The results of this testing indicate that the ARIX Humerus System is equivalent to predicate device.
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
May 3, 2023
Image /page/0/Picture/1 description: The image contains 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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 Korea, South
Re: K230938
Trade/Device Name: ARIX Humerus 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: March 31, 2023 Received: April 3, 2023
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.
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
1
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 mediation-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,
Image /page/1/Picture/5 description: The image shows the name "Shumaya Ali-S" in a large, sans-serif font. The text is black against a light background. The name appears to be a person's name, with a hyphenated last name or initial.
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K230938
Device Name
ARIX Humerus System
Indications for Use (Describe)
The ARIX Humerus System is indicated for fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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FORM FDA 3881 (6/20)
PSC Publishing Services (301) 443-6740 EF
3
510(k) Summary
[As required by 21 CRF 807.92]
1. Date Prepared [21 CRF 807.92(a)(a)]
31th March 2023
Submitter's Information [21 CFR 807.92(a)(1)] 2.
| Name of Sponsor: | Jeil Medical Corporation |
|---|---|
| Address: | 702-703-704-705-706-804-805-807-812-815-ho,55 Digital-ro34-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 |
| Registration Number: | 3004049923 |
| • Name of Manufacturer: | Same as Sponsor |
|---|---|
| - Address: | Same as Sponsor |
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] 3.
| ● | Trade Name: | ARIX Humerus System |
|---|---|---|
| ● | Common Name: | Plate, Fixation, Bone / Screw, Fixation Bone |
| ● | Classification Name: | Single/multiple component metallic bone fixation appliances and |
| accessories (Primary), | ||
| / Smooth or threaded metallic bone fixation fastener | ||
| ● | Classification Panel: | Orthopedic |
| ● | Classification Regulation: | 21 CFR 888.3030(Primary), 21 CFR 888.3040 |
| ● | Product Code: | HRS(Primary), HWC |
| ● | Device Class: | II |
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Identification of Predicate Device(s) [21 CFR 807.92(a)(3)| 4.
The identified predicate devices within this submission are the only primary predicate device and are shown as follow;
| • 510(k) Number: | K172008 |
|---|---|
| • Applicant: | Jeil Medical Corporation |
| • Common Name: | Bone Plate and Bone Screw |
- Device Name: ARIX Humerus System
There are no significant differences between the subject devices devices (K172008) 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 Humerus System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes.
The ARIX Humerus System is consists of plates and screws. The ARIX Humerus 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 screws vary essentially through different lengths and diameters. It also includes various manual surgical instruments, as drill bits, driver shafts, depth gauge.
The ARIX Humerus System is not provided sterile. It is required to reach a SAL of 106 by the hospital prior to surgery.
6. Indication for use [21 CFR 807.92(a)(5)]
ARIX Humerus System is indicated for fractures, fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
ARIX Humerus System, Bone Plate:
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 variable locking feature, similar to the design used in the predicate device (K172008).
ARIX Humerus System, Bone Screw:
ARIX Humerus System is the same as the screws of the cleared ARIX Humerus System (K172008) without any changes.
5
Non-Clinical Test Summary:
Bench tests were conducted to verify that the proposed device met all design specifications. The test results 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 Methods for Metallic Medical Bone Screws
The following tests were performed with the predicate device:
- Plate
- Bending strength test per ASTM F382 -
- Bending fatigue test per ASTM F382 -
The results of this testing indicate that the ARIX Humerus System is equivalent to predicate device.
Clinical Test Summary
No clinical studies were considered necessary and performed.
8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]
When compared to the predicate device (K152158), the ARIX Humerus System presented in this submission has the same:
- . Indication for use
- Technical characteristics .
- . Operating Principle
- . Design Features
- Performance
- Biocompatibility .
- Materials .
- . Method of sterilization
Conclusion [21 CFR 807.92(b)(3)] 9.
In all respects, the ARIX Humerus System is the equivalent of currently marketed devices. This device is made of same materials and has similar dimensions and characteristics. The ARIX Humerus System is manufactured from the unalloyed titanium alloy that is used generally in this kind of bone plate and bone screw system. Based on the information submitted, ARIX Humerus System is substantially equivalent to the currently marketed predicate devices.