(105 days)
Not Found
No
The summary describes a mechanical intramedullary nail system and its performance in mechanical tests, with no mention of AI or ML technology.
No
The device is an intramedullary nail system used for the fixation of ulna fractures and osteotomies, which is a restorative mechanical intervention rather than a therapeutic treatment in itself.
No
The device is described as an intramedullary nail system intended for the fixation of fractures and osteotomies of the ulna. Its purpose is to physically stabilize bones, not to diagnose conditions.
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. The performance studies also focus on mechanical testing of these physical implants.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "fixation of fractures and osteotomies of the ulna." This describes a surgical implant used to stabilize bone, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details a physical implant (intramedullary nail, screws) designed to be inserted into the bone. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: The document 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 a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The Flex-Thread™ Ulna Intramedullary Nail System is intended for use in the fixation of fractures and osteotomies of the ulna.
Product codes
HSB
Device Description
The Flex-Thread™ Ulna Intramedullary Nail System is comprised of an intramedullary fixation device with a flexible threaded tip to engage the intramedullary canal of the ulnar diaphysis from an antegrade approach and cortical screws to provide stability and articular support in the proximal ulna and olecranon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ulna, ulnar diaphysis, proximal ulna, olecranon
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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.
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)
The Flex-Thread Ulna implants were subjected to several mechanical tests with the intent of proving substantial equivalence to a predicate device. The following tests were identified according to the consensus standard ASTM F1264 - Standard Specification and Test Methods for Intramedullary Fixation Devices:
· Static Four Point Bend
· Static Torsion
· Bending Fatigue
· Bending Fatigue of Interlocking Screws
Additionally, insertion torque and implant tip deflection were considered to evaluate the safety and efficacy of the device.
Non-clinical performance testing demonstrates that the Flex-Thread™ Una Intramedullary Nail System is substantially equivalent to the predicate device
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.
0
November 21, 2022
Image /page/0/Picture/1 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Flower Orthopedics Corporation DBA Conventus Flower Christina Rovaldi Sr. Manager, RA/QA 100 Witmer Road Horsham, Pennsylvania 19044
Re: K222390
Trade/Device Name: Flex-Thread™ Ulna Intramedullary Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: October 26, 2022 Received: October 27, 2022
Dear Christina Rovaldi:
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/cfpm/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/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/cdrl-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,
Victoria A. Lilling -S Digitally signed by Victoria A. Lilling -S
Victoria Lilling, M.D. 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™ Ulna Intramedullary Nail System
Indications for Use (Describe)
The Flex-Thread™ Ulna Intramedullary Nail System is intended for use in the fixation of fractures and osteotomies of the ulna.
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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K222390 - Page 1 of 2
510(k) Summary
21 CFR 807.92(a)(1)
Prepared on: 2022-11-17
| Contact Details | 21 CFR 807.92(a)(1) | |||
|---|---|---|---|---|
| Applicant Name | Flower Orthopedics Corporation DBA Conventus Flower | |||
| Applicant Address | 100 Witmer Road Suite 280 Horsham PA 19044 United States | |||
| Applicant Contact Telephone | 2153234029 | |||
| Applicant Contact | Mrs. Christina Rovaldi | |||
| Applicant Contact Email | crovaldi@flowerortho.com | |||
| Device Name | 21 CFR 807.92(a)(2) | |||
| Device Trade Name | Flex-Thread™ Ulna 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 (Primary Predicate is listed first) | Product Code | ||
| K202858 | Conventus Flower Orthopedics Flex-Thread™ Distal Fibula Intrar | HSB | ||
| K042135 | Synthes (Usa) Elastic Intramedullary Nail (Ein) System (Line Exte | HSB | ||
| Device Description Summary | 21 CFR 807.92(a)(4) | |||
| The Flex-Thread™ Ulna Intramedullary Nail System is comprised of an intramedullary fixation device with a flexible threaded tip to | ||||
| engage the intramedullary canal of the ulnar diaphysis from an antegrade approach and cortical screws to provide stability and articular | ||||
| support in the proximal ulna and olecranon. | ||||
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) | |||
| The Flex-Thread™ Ulna Intramedullary Nail System is intended for use in the fixation of fractures and osteotomies of the ulna. | ||||
| Indications for Use Comparison | 21 CFR 807.92(a)(5) | |||
| Both devices are used in the treatment of fractures and osteotomies. The proposed device offers treatment of fractures and osteotomies | ||||
| of the ulna versus the predicate indications which offers the same treatment but for the fibula. The use of the device in a different | ||||
| anatomic area is supported by the additional predicate identified within the same regulation. | ||||
| Technological Comparison | 21 CFR 807.92(a)(6) |
Technological Comparison
This Traditional 510(k) is submitted to introduce a 4.5mm, 6.5mm and 7.5mm diameter nail in 120mm, 150mm, 210mm, 210mm, 210mm, 240mm, 270mm and 290mm lengths as well as additional end caps in 10mm and 20mm. The proposed additions to the Flex-Thread™ System have the same technological characteristics as the predicate device Flex-Thread™ System.
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Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The Flex-Thread Ulna implants were subjected to several mechanical tests with the intent of proving substantial equivalence to a predicate device. The following tests were identified according to the consensus standard ASTM F1264 - Standard Specification and Test Methods for Intramedullary Fixation Devices:
· Static Four Point Bend
- · Static Torsion
· Bending Fatigue
· Bending Fatigue of Interlocking Screws
Additionally, insertion torque and implant tip deflection were considered to evaluate the safety and efficacy of the device.
Not Applicable
Non-clinical performance testing demonstrates that the Flex-Thread™ Una Intramedullary Nail System is substantially equivalent to the predicate device