(266 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of metallic implants, with no mention of AI or ML.
No
The device is described as a system of metallic bone fixation plates and screws used for the fixation of fractures, osteotomies, and non-unions, which falls under the category of orthopedic hardware rather than a therapeutic device in the sense of delivering treatment or therapy.
No
Explanation: The device is described as a "Trauma System" consisting of bone fixation plates and screw fasteners used for "fixation of fractures, osteotomies, and non-unions." Its intended use is to treat existing conditions, not to diagnose them.
No
The device description explicitly states that the system consists of "metallic bone fixation plates and metallic screw fasteners," 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 is for the fixation of fractures, osteotomies, and non-unions of various bones in adult patients. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of metallic bone plates and screws, which are implants used to stabilize bone.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The HKT Anatomical Locking Trauma System is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The HKT Anatomical Locking Trauma System is intended for adult patients for fixation of fractures, osteotomies, and non-unions of the clavicle, tibia, femur, fibula, radius, ulna, humerus and pelvis.
Product codes
HRS, HWC
Device Description
The HKT Anatomical Locking Trauma System consists of metallic bone fixation plates and metallic screw fasteners. The bone plates and screws are composed of titanium alloy Ti-6Al-4V and commercially pure (Cp) titanium. The devices are used for fixation of fractures, osteotomies, and non-unions of the clavicle, tibia, femur, fibula, radius, ulna, humerus and pelvis. The bone plates are anatomically pre-contoured and offered in various shapes and sizes to allow for the orthopedic surgeon or equivalent medical professional to choose which device best fits each patient within the indication for use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, tibia, femur, fibula, radius, ulna, humerus and pelvis
Indicated Patient Age Range
adult patients
Intended User / Care Setting
orthopedic surgeon or equivalent medical professional
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)
The following tests were performed to demonstrate performance and safety based on current industry standards:
- Biocompatibility:
- Scientific Justification
- Cytotoxicity per ISO 10993-5
- Irritation per ISO 10993-23
- Acute and Subacute/Subchronic Systemic Toxicity per ISO 10993-11
- Performance Testing:
- Standard Specification and Test Method for Metallic Bone Plates per ASTM F382
- Standard Specification and Test Methods for Metallic Medical Bone Screws per ASTM F543
For all implants except the iliac plate, test results were compared to FDA guidance documents, "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway" and "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway."
The results of these tests indicate that the HKT Anatomical Locking Trauma System is substantially equivalent to the predicate device.
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
January 19, 2024
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 and 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.
Hankil Tech Medical Co., Ltd % Kim Jeong-Yup CEO 452-29, Pureundeulpan-ro, Paltan-myeon Hwaseong-si, 18532 Korea, South
Re: K231213
Trade/Device Name: HKT Anatomical Locking Trauma 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 21, 2023 Received: December 21, 2023
Dear Kim Jeong-Yup:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Shumaya Ali -S
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
2
Indications for Use
Submission Number (if known)
Device Name
| HKT Anatomical Locking Trauma System | |
|---|---|
| -- | -------------------------------------- |
Indications for Use (Describe)
The HKT Anatomical Locking Trauma System is intended for adult patients for fixation of fractures, osteotomies, and non-unions of the clavicle, tibia, femur, fibula, radius, ulna, humerus and pelvis.
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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Image /page/3/Picture/0 description: The image shows the logo for Hankil TECHMEDICAL. The logo consists of a blue circular design on the left, followed by the word "Hankil" in black, with the "il" in blue. Below "Hankil" is the word "TECHMEDICAL" in a smaller, black font. The logo is simple and modern, with a focus on the company name.
510(k) Summary
DATE PREPARED
January 18, 2024
MANUFACTURER AND 510(k) OWNER
Hankil Tech Medical Co. Ltd. 452-29, Pureudeulpan-ro, Paltan-myeon, Hwaseong-si, Gyeonggi-do, Republic of Korea Telephone: +82-31-354-6369 Official Contact: Kim Jeong-Yup, CEO Email: hankiltech(@hankiltech.com
REPRESENTATIVE/CONSULTANT
Lucie Dalet, Ph.D., Joy Gutermuth ROM+ 2251 San Diego Ave. Ste B-257, San Diego, CA 92110, USA Telephone: +1 (877) 652 0830 Email: ldalet(@rqmplus.com; jgutermuth(@rqmplus.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | HKT Anatomical Locking Trauma System |
|---|---|
| Common Name: | Plate, Fixation, Bone and Screw, Fixation, Bone |
| Regulation Numbers: | 21 CFR 888.3030, 21 CFR 888.3040 |
| Classification Names: | Single/multiple component metallic bone fixation appliances |
| and accessories, Smooth or threaded metallic bone fixation | |
| fastener | |
| Class: | II |
| Product Code: | HRS, HWC |
| Premarket Review: | OHT6/Orthopedic Devices (DHT6C) |
| Review Panel: | Orthopedic |
PREDICATE DEVICE IDENTIFICATION
The HKT Anatomical Locking Trauma System is substantially equivalent to the following primary predicate:
| 510(k) Number | Predicate Device Name / Manufacturer |
|---|---|
| K000684 | Small Fragment Dynamic Compression Locking (DCL) System/ Synthes (USA) |
The predicate devices have not been subject to a design related recall.
DEVICE DESCRIPTION
The HKT Anatomical Locking Trauma System consists of metallic bone fixation plates and metallic screw fasteners. The bone plates and screws are composed of titanium alloy Ti-6Al-4V and commercially pure (Cp) titanium. The devices are used for fixation of fractures, osteotomies, and non-unions of the clavicle, tibia, femur, fibula, radius, ulna, humerus and pelvis. The bone plates are
4
Image /page/4/Picture/0 description: The image shows the logo for Hankil TECHMEDICAL. The logo consists of a blue circular design on the left, followed by the word "Hankil" in bold black letters. Below "Hankil" is the word "TECHMEDICAL" in smaller, lighter letters. The logo appears to be for a medical technology company.
anatomically pre-contoured and offered in various shapes and sizes to allow for the orthopedic surgeon or equivalent medical professional to choose which device best fits each patient within the indication for use.
INDICATIONS FOR USE
The HKT Anatomical Locking Trauma System is intended for adult patients for fixation of fractures. osteotomies, and non-unions of the clavicle, tibia, femur, fibula, radius, ulna, humerus and pelvis.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Hankil Tech Medical believes that the HKT Anatomical Locking Trauma System is substantially equivalent to the predicate devices based on the information summarized here:
The subject device has a similar design and dimensions and uses similar materials to the device cleared in K000684. Both the subject and predicate devices offer plate models to fit various anatomical locations. The subject device bone plates and screws are offered in additional sizes and shapes that are not necessarily identical to the predicate device configurations, but these differences do not affect the indications or intended use of the devices. The subject device has the same intended use and similar technological characteristics such that differences in the configurations and sizes of bone screws and bone plates do not raise different questions of safety and effectiveness compared to the devices cleared in K000684. These technological characteristics have undergone testing to ensure the device is substantially equivalent to the predicate.
SUMMARY OF NON-CLINICAL TESTING
The following tests were performed to demonstrate performance and safety based on current industry standards:
- . Biocompatibility:
- Scientific Justification o
- Cytotoxicity per ISO 10993-5 O
- Irritation per ISO 10993-23 o
- Acute and Subacute/Subchronic Systemic Toxicity per ISO 10993-11 O
- Performance Testing:
- Standard Specification and Test Method for Metallic Bone Plates per ASTM F382 o
- Standard Specification and Test Methods for Metallic Medical Bone Screws per O ASTM F543
For all implants except the iliac plate, test results were compared to FDA guidance documents, "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway" and "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway."
The results of these tests indicate that the HKT Anatomical Locking Trauma System is substantially equivalent to the predicate device.
5
Image /page/5/Picture/0 description: The image shows the logo for Hankil TECHMEDICAL. The logo consists of a blue circular design on the left, followed by the word "Hankil" in bold black letters. Below "Hankil" is the word "TECHMEDICAL" in smaller, gray letters. The logo is simple and modern, with a focus on the company name.
SUMMARY OF NON-CLINICAL TESTING
No clinical data was provided to demonstrate substantial equivalence.
CONCLUSION
Based on the testing performed, including biocompatibility and performance testing per recognized consensus standards, it can be concluded that the subject devices are substantially equivalent to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed HKT Anatomical Locking Trauma System are assessed to be substantially equivalent to the predicate devices.