(204 days)
Not Found
No
The 510(k) summary describes a mechanical bone screw and does not mention any software, algorithms, or AI/ML capabilities. The performance studies focus on mechanical properties and MRI compatibility.
Yes.
The device is intended for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions, which are therapeutic interventions.
No
The device is described as screws for internal bone fixation in the foot and ankle, which are used in a plate-screw system. Its intended use is for treating bone fractures, fusions, osteotomies, and non-unions, indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly states the device is a physical screw made of Titanium, intended for internal bone fixation. It also describes physical characteristics like diameter and length, and performance studies related to mechanical strength and MRI compatibility, which are relevant to hardware.
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 screws are for "internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the foot and ankle." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details a physical implant (screws) made of titanium, with specific dimensions and sterilization status.
- Performance Studies: The performance studies focus on mechanical properties (torque, strength), MRI compatibility, and pyrogen testing, all relevant to a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Arthrex Low Profile Screws do not fit this definition.
N/A
Intended Use / Indications for Use
The Arthrex Low Profile Screws are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the foot and ankle. The screws may be used with the Arthrex Ankle Fusion Plates.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HRS
Device Description
The Arthrex Low Profile Screws are headed and self-tapping screws manufactured from Titanium. They are available as fully and solid. The screw family ranges from 4.5 mm to 5.5 mm in diameter and from 80 mm to 120 mm in length (in 5 mm increments). The Arthrex Low Profile Screws are sold as sterile, single-use and non-sterile single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Arthrex performed driving torque and failure torque/insertion testing to evaluate the potential risk of decrease in mechanical strength.
MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.
Bacterial Endotoxins Test (BET) was performed on the Arthrex Low Profile Screws utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14. The testing conducted demonstrates that the Arthrex Low Profile Screws meets pyrogen limit specifications.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 30, 2019
Arthrex Inc. Heli Chambi Infantas Senior Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K190921
Trade/Device Name: Arthrex Low Profile Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HRS Dated: September 27, 2019 Received: September 30, 2019
Dear Heli Chambi Infantas:
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
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Indications for Use
510(k) Number (if known) K190921
Device Name Arthrex Low Profile Screws
Indications for Use (Describe)
The Arthrex Low Profile Screws are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the foot and ankle. The screws may be used with the Arthrex Ankle Fusion Plates.
| 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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510(k) Summary
| Date Prepared | October 30, 2019 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Heli F Chambi Infantas |
| Senior Regulatory Affairs Associate | |
| 1-239-643-5553, ext. 71263 | |
| Heli.chambiinfantas@arthrex.com | |
| Name of Device | Arthrex Low Profile Screws |
| Common Name | Screw, Fixation, Bone |
| Plate, Fixation, Bone | |
| Product Code | HWC, HRS |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and | |
| accessories | |
| Regulatory Class | II |
| Predicate Device | K141735 – Arthrex Ankle Fusion Plating System |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to obtain clearance for the |
| Arthrex Low Profile screws as a line extension to the Arthrex Ankle Fusion plating | |
| System cleared under K141735. | |
| Device Description | The Arthrex Low Profile Screws are headed and self-tapping screws manufactured |
| from Titanium. They are available as fully and solid. The screw family ranges from 4.5 | |
| mm to 5.5 mm in diameter and from 80 mm to 120 mm in length (in 5 mm | |
| increments). The Arthrex Low Profile Screws are sold as sterile, single-use and non- | |
| sterile single-use. | |
| Indications for Use | The Arthrex Low Profile Screws are intended to be used in a plate-screw system for |
| internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the | |
| foot and ankle. The screws may be used with the Arthrex Ankle Fusion Plates. | |
| Performance Testing | Arthrex performed driving torque and failure torque/insertion testing to evaluate the |
| potential risk of decrease in mechanical strength. |
MRI force, torque, and image artifact testing were conducted in accordance with FDA
guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance
(MR) Environment.
Bacterial Endotoxins Test (BET) was performed on the Arthrex Low Profile Screws
utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI
ST72:2011/(R)2016, USP , USP , EP 2.6.14. The testing conducted
demonstrates that the Arthrex Low Profile Screws meets pyrogen limit specifications. |
| Conclusion | The Arthrex Low Profile screws are substantially equivalent to the predicate device in
which the basic design features and intended use are the same. Any differences
between the Arthrex Low Profile screws and the predicates are considered minor and
do not raised different questions concerning safety and effectiveness. 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 |