(136 days)
Not Found
No
The summary describes a system of plates and screws for bone fixation and does not mention any AI or ML components or functionalities.
Yes
Explanation: The device is intended for the fixation of fractures, osteotomies, nonunions, replantations, and fusions, which are all therapeutic interventions aimed at treating a medical condition or injury.
No
The device is a fixation system (plates and screws) used for orthopedic repair, not for diagnosing conditions.
No
The device description explicitly states it consists of physical plates and screws 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/Indications for Use: The intended use clearly states the device is for the fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details plates and screws made of titanium, designed to be implanted into bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical fixation.
N/A
Intended Use / Indications for Use
The Arthrex Mini Comprehensive Fixation System Plates (2.0-2.4 mm) are intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle. The Arthrex Mini Comprehensive Fixation System Plates are to be used with the Arthrex Mini Comprehensive Fixation System Screws (2.0-2.4 mm solid).
The Arthrex Mini Comprehensive Fixation System Screws (2.0-2.4 mm solid) are intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle. The Arthrex Mimi Comprehensive Fixation System Screws are to be used with the Arthrex Mini Comprehensive Fixation System Plates (2.0-2.4 mm).
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Arthrex Mini Comprehensive Fixation System - 2.0mm & 2.4mm Module consists of a series of plates and screws of varying lengths and thickness. The plates are contoured to fit the various aspects of the hand, wrist, foot and ankle including Straight, T-, Y-, V-, Cage, Triangular and Bridge. The plates are attached to bone with 2.0 mm and 2.4 mm cortical and variable locking screws. The screws range from 2.0 mm to 2.4 mm in diameter and from 6 mm to 40 mm in length. The plates and screws are manufactured from titanium. The plates and screws are sold non-sterile and single-use.
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
Prescription Use
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)
Pull-out (ASTM F543), insertion torque/failure torque, static four-point bend (ASTM F382) and four-point bend fatigue testing (ASTM F382) was conducted to demonstrate that the proposed Arthrex Mini Comprehensive Fixation System - 2.0mm & 2.4mm Module performs statistically equivalent to the predicate.
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
October 3, 2019
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: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" and then "ADMINISTRATION" in a smaller font size.
Arthrex Inc. Rebecca R. Homan Senior Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K191344
Trade/Device Name: Arthrex Mini Comprehensive Fixation System - 2.0mm & 2.4mm Module 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: August 29, 2019 Received: August 30, 2019
Dear Rebecca R. Homan:
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 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
1
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,
For, 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191344
Device Name
Arthrex Mini Comprehensive Fixation System - 2.0mm & 2.4mm Module
Indications for Use (Describe)
The Arthrex Mini Comprehensive Fixation System Plates (2.0-2.4 mm) are intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle. The Arthrex Mini Comprehensive Fixation System Plates are to be used with the Arthrex Mini Comprehensive Fixation System Screws (2.0-2.4 mm solid).
The Arthrex Mini Comprehensive Fixation System Screws (2.0-2.4 mm solid) are intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle. The Arthrex Mimi Comprehensive Fixation System Screws are to be used with the Arthrex Mini Comprehensive Fixation System Plates (2.0-2.4 mm).
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) |
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3
510(k) Summary or 510(k) Statement
| Date Prepared | August 29, 2019 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Rebecca R. Homan |
| Senior Regulatory Affairs Associate | |
| 1-239-643-5553, ext. 73429 | |
| rebecca.homan@arthrex.com | |
| Name of Device | Arthrex Mini Comprehensive Fixation System - 2.0mm & 2.4mm Module |
| Common Name | Single/multiple component metallic bone fixation appliances and accessories |
| Smooth or threaded metallic bone fixation fastener | |
| Product Code | HRS; HWC |
| Classification Name | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances |
| and accessories | |
| 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener | |
| Regulatory Class | II |
| Predicate Device | K063049: Synthes (USA) Modular Mini Fragment LCP System |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for |
| the Arthrex Mini Comprehensive Fixation System - 2.0mm & 2.4mm Module. | |
| Device Description | The Arthrex Mini Comprehensive Fixation System - 2.0mm & 2.4mm Module |
| consists of a series of plates and screws of varying lengths and thickness. The | |
| plates are contoured to fit the various aspects of the hand, wrist, foot and ankle | |
| including Straight, T-, Y-, V-, Cage, Triangular and Bridge. The plates are attached | |
| to bone with 2.0 mm and 2.4 mm cortical and variable locking screws. The | |
| screws range from 2.0 mm to 2.4 mm in diameter and from 6 mm to 40 mm in | |
| length. The plates and screws are manufactured from titanium. The plates and | |
| screws are sold non-sterile and single-use. | |
| Indications for Use | The Arthrex Mini Comprehensive Fixation System Plates (2.0-2.4 mm) are |
| intended for fixation of fractures, osteotomies, nonunions, replantations, and | |
| fusions of small bones and small bone fragments, particularly in osteopenic bone. | |
| Examples include, but are not limited to, the hand, wrist, foot, and ankle. The | |
| Arthrex Mini Comprehensive Fixation System Plates are to be used with the | |
| Arthrex Mini Comprehensive Fixation System Screws (2.0-2.4 mm solid). |
The Arthrex Mini Comprehensive Fixation System Screws (2.0-2.4 mm solid) are
intended for fixation of fractures, osteotomies, nonunions, replantations, and
fusions of small bones and small bone fragments, particularly in osteopenic bone.
Examples include, but are not limited to, the hand, wrist, foot, and ankle. The
Arthrex Mini Comprehensive Fixation System Screws are to be used with the
Arthrex Mini Comprehensive Fixation System Plates (2.0-2.4 mm). |
| Performance Data | Pull-out (ASTM F543), insertion torque/failure torque, static four-point bend
(ASTM F382) and four-point bend fatigue testing (ASTM F382) was conducted to
demonstrate that the proposed Arthrex Mini Comprehensive Fixation System -
2.0mm & 2.4mm Module performs statistically equivalent to the predicate. |
| Conclusion | The Arthrex Mini Comprehensive Fixation System - 2.0mm & 2.4mm Module is
substantially equivalent to the predicate device in which the basic design features
and intended uses are the same. Any differences between the proposed device
and the predicate device are considered minor and do not raise different |
| questions concerning safety or effectiveness. | |
| The submitted mechanical testing data demonstrates that the pull-out, torque,
bending strength and the fatigue strength of the proposed devices are
substantially equivalent to that of the predicate device for the desired
indications. | |
| Based on the indications for use, technological characteristics, and the summary
of data submitted, Arthrex Inc. has determined that the proposed device is
substantially equivalent to the currently marketed predicate device. | |
4