(116 days)
Not Found
No
The summary describes a mechanical implant system and its performance testing, with no mention of AI or ML technologies.
No
The device is described as an intramedullary nail system for fixation of fibula fractures and osteotomies, which is a structural support device rather than one that treats or prevents a disease or condition.
No
The device is described as an intramedullary nail system used for fixation of fibula fractures and osteotomies, which is a treatment not a diagnostic function.
No
The device description explicitly 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 for the "fixation of fibula fractures and osteotomies." This is a surgical procedure performed directly on the patient's body to stabilize bone.
- Device Description: The device is an "intramedullary fixation device with a flexible threaded tip" and "cortical screws." These are physical implants used within the body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This device does not perform such testing.
The information provided clearly describes a surgical implant used for bone fixation, not a diagnostic test performed on samples outside the body.
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 (comma separated list FDA assigned to the subject device)
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 original Flex-Thread Fibula Pin System design and submitted in K172943. The following analyses were conducted:
- Tip Reaction Force
- 4-Point Bend per ASTM F1264
- Torque Strength
- Insertion and Removal Torque
Additionally, simulated use of the Flex-Thread™ Distal Fibula Intramedullary Nail System was used in a cadaver lab to validate the modified design. The results demonstrate that the modified Flex-Thread™ Distal Fibula Intramedullary Nail System is substantially equivalent to the predicate device in safety and performance.
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
§ 888.3020 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
January 22, 2021
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, featuring an abstract symbol and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". To the right is the FDA logo, with the letters "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Conventus Orthopaedics, LLC Amanda Pentecost RA/QA Engineer 10200 73rd Ave N. Suite 122 Maple Grove, Minnesota 55369
Re: K202858
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: December 21, 2020 Received: December 22, 2020
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
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 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
2
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)
( Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Contact Details (21 CFR 807.92(a)(1)) | ||
|---|---|---|
| Applicant Name | Conventus Orthopaedics, LLC | |
| Applicant Address | 10200 73rd Ave N. Suite 122 | |
| Maple Grove MN 55369 | ||
| United States of America | ||
| Applicant Contact Telephone | 215-323-4029 | |
| Applicant Contact | Dr. Amanda Pentecost | |
| Applicant Contact Email | apentecost@flowerortho.com | |
| Device Name (21 CFR 807.92(a)(2)) | ||
| Device Trade Name | Flex-Thread™ Distal Fibula Intramedullary Nail System | |
| Common Name | Rod, Fixation, Intramedullary And Accessories | |
| Classification Name | Intramedullary Fixation Rod | |
| Regulation Number | 888.3020 | |
| Product Code | HSB | |
| Legally Marketed Predicate Devices (21 CFR 807.92(a)(3)) | ||
| Predicate # | Predicate Trade Name | Product Code |
| K172943 | Flex-Thread Fibula Pin | |
| 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 (21 CFR 807.92(a)(5) | ||
| The Flex-Thread™ Distal Fibula Intramedullary Nail System is intended for use in the fixation of fibula | ||
| fractures and osteotomies. | ||
| Indications for Use Comparison (21 CFR 807.92(a)(5)) | ||
| The Flex-Thread™ Distal Fibula Intramedullary Nail System has the same indications for use as the | ||
| predicate Intrafuse Flex-Thread Fibula Pin System. | ||
| Technological Comparison (21 CFR 807.92(a)(6)) | ||
| The functional design intent of the Flex-Thread™ Distal Fibula Intramedullary Nail System is identical | ||
| to the Flex-Thread Fibula Pin in that the devices are intended to engage the region of the fibula | ||
| intramedullary canal proximal to the fracture. Dimensional changes to implants and instruments have | ||
| been made to meet user needs and do not raise new questions related to safety and effectiveness as | ||
| demonstrated by non-clinical testing. The Flex-Thread™ Distal Fibula Intramedullary Nail features a | ||
| partially threaded shaft with an additional distal hole and longer screw lengths. The Flex-Thread™ | ||
| Distal Fibula Intramedullary Nail System also features standard cortex screws, which are available in | ||
| longer sizes to allow for syndesmosis repair and introduces low-profile locking cortex screws. | ||
| 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 original Flex-Thread Fibula Pin System | ||
| design and submitted in K172943. The following analyses were conducted: | ||
| ● Tip Reaction Force | ||
| ● 4-Point Bend per ASTM F1264 | ||
| ● Torque Strength |
4
Insertion and Removal Torque ●
Additionally, simulated use of the Flex-Thread™ Distal Fibula Intramedullary Nail System was used in a cadaver lab to validate the modified design. The results demonstrate that the modified Flex-Thread™ Distal Fibula Intramedullary Nail System is substantially equivalent to the predicate device in safety and performance.