(152 days)
Not Found
No
The device description and performance studies focus on mechanical properties of plates and screws for bone fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a system of plates and screws used for mechanical fixation in trauma and reconstructive procedures, not for therapy.
No
The device is a fixation system consisting of plates and screws used in surgery for trauma and reconstructive procedures. It is an implantable medical device, not a diagnostic tool.
No
The device description clearly states it consists of physical components (plates and screws) made of titanium, which are hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "selective trauma, reconstructive procedures, and general surgery of the hand, wrist, and other small bones." This describes a surgical implant used in vivo (within the body) to fix bones.
- Device Description: The description details plates and screws made of titanium, designed to be attached to bone. This is consistent with surgical implants, not devices used to test samples in vitro (outside the body).
- No mention of in vitro testing: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests outside the body to diagnose a condition.
- Performance Studies: The performance studies described are mechanical tests (pull-out, torque, bending) which are relevant to the structural integrity and function of a surgical implant, not the analytical performance of an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to physically fix bones.
N/A
Intended Use / Indications for Use
The Arthrex Mini Comprehensive Fixation System Plates (1.4-1.6 mm) are intended for use in selective trauma, reconstructive procedures, and general surgery of the hand, wrist, and other small bones. The Arthrex Comprehensive Fixation System Plates are to be used with the Arthrex Mini Comprehensive Fixation System Screws (1.4-1.6 mm solid).
The Arthrex Mini Comprehensive Fixation System Screws (1.4-1.6 mm solid) are intended for use in selective trauma, reconstructive procedures, and general surgery of the hand, wrist, and other small bones. The Arthrex Comprehensive Fixation System Screws are to be used with the Arthrex Mini Comprehensive Fixation System Plates (1.4-1.6 mm).
Product codes
HRS, HWC
Device Description
The Arthrex Mini Comprehensive Fixation System - 1.4mm & 1.6mm 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 and wrist including straight, T-, Y-, Z-, Hook, Triangular, Cage and Bridge configurations. The plates are attached to bone with 1.4 mm and 1.6 mm cortical and variable locking screws. The screws range from 1.4 mm to 1.6 mm in diameter and from 6 mm to 24 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, and other small bones
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)
Pull-out (ASTM F543), insertion torque/failure torque, static four-point bend (ASTM F382) and four-point bend fatigue (ASTM F382) testing was conducted to demonstrate that the proposed Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module performs statistically equivalent to the predicate. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
October 15, 2019
Arthrex Inc. Rebecca Homan Senior Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K191326
Trade/Device Name: Arthrex Mini Comprehensive Fixation System - 1.4mm & 1.6mm 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: October 15, 2019
Dear Rebecca 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
1
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 (OS) 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,
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
Indications for Use
510(k) Number (if known) K191326
Device Name
Arthrex Mini Comprehensive Fixation System - 1.4mm & 1.6mm Module
Indications for Use (Describe)
The Arthrex Mini Comprehensive Fixation System Plates (1.4-1.6 mm) are intended for use in selective trauma, reconstructive procedures, and general surgery of the hand, wrist, and other small bones. The Arthrex Comprehensive Fixation System Plates are to be used with the Arthrex Mini Comprehensive Fixation System Screws (1.4-1.6 mm solid).
The Arthrex Mini Comprehensive Fixation System Screws (1.4-1.6 mm solid) are intended for use in selective trauma, reconstructive procedures, and general surgery of the hand, wrist, and other small bones. The Arthrex Comprehensive Fixation System Screws are to be used with the Arthrex Mini Comprehensive Fixation System Plates (1.4-1.6 mm).
| 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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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 |
| Regulatory Affairs Associate | |
| 1-239-643-5553, ext. 73429 | |
| rebecca.homan@arthrex.com | |
| Name of Device | Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm 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 | K030310: Synthes Stainless Steel Modular Hand System |
| Purpose of | |
| Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for |
| the Arthrex Mini Comprehensive Fixation System - 1.4mm & 1.6mm Module. | |
| Device Description | The Arthrex Mini Comprehensive Fixation System - 1.4mm & 1.6mm 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 and wrist including | |
| straight, T-, Y-, Z-, Hook, Triangular, Cage and Bridge configurations. The plates | |
| are attached to bone with 1.4 mm and 1.6 mm cortical and variable locking | |
| screws. The screws range from 1.4 mm to 1.6 mm in diameter and from 6 mm to | |
| 24 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 (1.4-1.6 mm) are |
| intended for use in selective trauma, reconstructive procedures, and general | |
| surgery of the hand, wrist, and other small bones. The Arthrex Comprehensive | |
| Fixation System Plates are to be used with the Arthrex Mini Comprehensive | |
| Fixation System Screws (1.4-1.6 mm solid). | |
| The Arthrex Mini Comprehensive Fixation System Screws (1.4-1.6 mm solid) are | |
| intended for use in selective trauma, reconstructive procedures, and general | |
| surgery of the hand, wrist, and other small bones. The Arthrex Comprehensive | |
| Fixation System Screws are to be used with the Arthrex Mini Comprehensive | |
| Fixation System Plates (1.4-1.6 mm). | |
| Performance Data | Pull-out (ASTM F543), insertion torque/failure torque, static four-point bend |
| (ASTM F382) and four-point bend fatigue (ASTM F382) testing was conducted to | |
| demonstrate that the proposed Arthrex Mini Comprehensive Fixation System – | |
| 1.4mm & 1.6mm Module performs statistically equivalent to the predicate. | |
| Conclusion | The Arthrex Mini Comprehensive Fixation System - 1.4mm & 1.6mm 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. |
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| 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. |