(24 days)
No
The summary describes a mechanical implant system for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an intramedullary nail system intended for the fixation of fibula fractures and osteotomies, which is a therapeutic purpose.
No
This device is a surgical implant designed for the fixation of fibula fractures and osteotomies, not for diagnosing medical conditions. Its description focuses on fixation and stability rather than diagnosis.
No
The device description clearly states it is comprised of an intramedullary fixation device with a flexible threaded tip and cortical screws, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fixation of fibula fractures and osteotomies." This describes a surgical procedure to stabilize bone, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The device is an "intramedullary fixation device with a flexible threaded tip... and cortical screws." This is a physical implant used within the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening
This device is clearly a surgical implant used for orthopedic fixation.
N/A
Intended Use / Indications for Use
The Flex-Thread™ Distal Fibula Intramedullary Nail System is intended for use in the fixation of fibula fractures and osteotomies.
Product codes
HSB
Device Description
The Flex-Thread™ Distal Fibula Intramedullary Nail System is comprised of an intramedullary fixation device with a flexible threaded tip to engage the proximal portion of a fibula and cortical screws to further enhance stability and fixation of the fibula.
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)
Mechanical testing was performed on the modified Flex-Thread™ Distal Fibula Intramedullary Nail System using the same protocols as those used to verify the Flex-Thread™ Distal Fibula Intramedullary Nail System design as part of K202858. These tests included Tip Reaction Force, Insertion Torque, and Simulated Use Cadaver Lab. Additionally, engineering justifications were provided for 4-Point Bend and Torque Strength testing. The results design inputs meet design outputs and substantial equivalence of the subject device to the predicate.
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
§ 888.3020 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Flower Orthopedics Corporation DBA Conventus Flower Amanda Pentecost RA/QA Engineer 100 Witmer Road Horsham, Pennsylvania 19044
Re: K212030
Trade/Device Name: Flex-Thread™ Distal Fibula Intramedullary Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: June 28, 2021 Received: June 29, 2021
Dear Amanda Pentecost:
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
July 23, 2021
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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 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,
For Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Flex-Thread™ Distal Fibula Intramedullary Nail System
Indications for Use (Describe)
The Flex-Thread™ Distal Fibula Intramedullary Nail System is intended for use in the fixation of fibula fractures and osteotomies.
Type of Use (Select one or both, as applicable)
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summary
Contact Details 21 CFR 807.92(a)(1) Flower Orthopedics Corporation DBA Conventus Flower Orthopedics Applicant Name Applicant Address 100 Witmer Road Suite 280 Horsham PA 19044 United States 215-323-4029 Applicant Contact Telephone Applicant Contact Dr. Amanda Pentecost Applicant Contact Email apentecost@flowerortho.com Device Name 21 CFR 807.92(a)(2) Flex-Thread™ Distal Fibula Intramedullary Nail System (Multiple Device Trade Name Component PNs) Rod, Fixation, Intramedullary And Accessories Common Name Classification Name Intramedullary fixation rod Regulation Number 888.3020 Product Code HSB Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate Trade Name (Primary Predicate is listed first) Predicate # Product Code K202858 Flex-Thread™ Distal Fibula Intramedullary Nail System HSB Device Description Summary 21 CFR 807.92(a)(4) The Flex-Thread™ Distal Fibula Intramedullary Nail System is comprised of an intramedullary fixation device with a flexible threaded tip to engage the proximal portion of a fibula and cortical screws to further enhance stability and fixation of the fibula.
Intended Use/Indications for Use
The Flex-Thread TM Distal Fibula Intramedullary Nail System is intended for use in the fixation of fibula fractures and osteotomies.
Indications for Use Comparison
This Special 510(k) is submitted to introduce a 5.5mm diameter nail in 130mm lengths as well as an additional end cap that is 1 mm to the Flex-Thread System. The Flex-Thread System have identical indications for use as the predicate device Flex-Thread System.
Technological Comparison
The only difference between the predicate device is the introduction of a larger nal with a diameter of 5.5mm compared to the originally cleared 3.5mm diameter nails. Additionally a shorter 1mm end cap has been added to the
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
21 CFR 607.32(a)(3)
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predicate offering of 3mm, 5mm and 10mm.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Mechanical testing was performed on the modified Flex-Thread™ Distal Fibula Intramedullary Nail System using the same protocols as those used to verify the Flex-Thread™ Distal Fibula Intramedullary Nail System design as part of K202858. These tests included Tip Reaction Force, Insertion Torque, and Simulated Use Cadaver Lab. Additionally, engineering justifications were provided for 4-Point Bend and Torque Strength testing. The results design inputs meet design outputs and substantial equivalence of the subject device to the predicate.