(239 days)
No
The summary describes a mechanical implant and associated hardware for fracture fixation, with no mention of AI or ML capabilities.
Yes
The device is intended for the fixation of fibula fractures and osteotomies, which is a therapeutic intervention.
No
The device is described as an implant used for the fixation of fibula fractures and osteotomies, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states it is a stainless steel implant used with stainless steel bone screws, indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Arthrex FibuLock Nail is described as a "stainless steel implant used with stainless steel bone screws for the fixation of fibula fractures and osteotomies." This clearly indicates it is an implantable device used within the body for structural support and fixation.
- Intended Use: The intended use is "in the fixation of fibula fractures and osteotomies." This is a surgical procedure, not a diagnostic test performed on a sample.
The information provided describes a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Arthrex FibuLock Nail is intended for use in the fixation of fibula fractures and osteotomies.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Arthrex FibuLock Nail is used in the Fibula Repair System cleared under K160069. It is a stainless steel implant used with stainless steel bone screws for the fixation of fibula fractures and osteotomies. The Arthrex FibuLock Nail can be used with existing FDA cleared Arthrex Low Profile Cortical Screws (K141478, K143139 and K143614), Arthrex TightRope Syndesmosis Devices (K043248) and instrumentation required for the fixation of fibula fractures and osteotomies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fibula
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)
Worst-Case Cross-Section Comparison was conducted on the Arthrex FibuLock Nail to assess the risk of decreased bending strength. Axial pullout and torsion comparison testing was performed on the 2.7 mm distal screws.
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.
K160069: Sonoma Fibula Repair System
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.
K141478, K143139, K143614, K043248
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized depiction of a human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
Arthrex, Inc. Rebecca Homan Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K173656
Trade/Device Name: Arthrex FibuLock Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: June 22, 2018 Received: June 25, 2018
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 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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jesse Muir -S 2018.07.26 17:41:46 -04'00' In lieu of. Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173656
Device Name
Arthrex FibuLock Nail
Indications for Use (Describe)
The Arthrex FibuLock Nail is intended for use in the fixation of fibula fractures and osteotomies.
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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510(k) Summary
| Date Prepared | July 25, 2018 |
|---|---|
| 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 FibuLock Nail |
| Common Name | Rod, Fixation, Intramedullary and Accessories |
| Product Code | HSB |
| Classification Name | 21 CFR 888.3020: Intramedullary Fixation Rod |
| Regulatory Class | II |
| Predicate Device | K160069: Sonoma Fibula Repair System |
| Purpose of | This Special 510(k) premarket notification is submitted to obtain clearance for the |
| Submission | Arthrex FibuLock Nail, which is a modified version of the Sonoma Fibular Nail |
| previously cleared under K160069 Sonoma Fibula Repair System. | |
| Device Description | The Arthrex FibuLock Nail is used in the Fibula Repair System cleared under |
| K160069. It is a stainless steel implant used with stainless steel bone screws for | |
| the fixation of fibula fractures and osteotomies. The Arthrex FibuLock Nail can be | |
| used with existing FDA cleared Arthrex Low Profile Cortical Screws (K141478, | |
| K143139 and K143614), Arthrex TightRope Syndesmosis Devices (K043248) and | |
| instrumentation required for the fixation of fibula fractures and osteotomies. | |
| Indications for Use | The Arthrex FibuLock Nail is intended for use in the fixation of fibula fractures |
| and osteotomies. | |
| Performance Data | Worst-Case Cross-Section Comparison was conducted on the Arthrex FibuLock |
| Nail to assess the risk of decreased bending strength. Axial pullout and torsion | |
| comparison testing was performed on the 2.7 mm distal screws. | |
| Conclusion | The Arthrex FibuLock Nail 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 questions concerning safety or 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. | |