(49 days)
No
The summary describes a mechanical intramedullary nail system and does not mention any AI or ML components or functionalities.
Yes.
The device is intended for the treatment of diaphyseal fractures of long bones, which is a therapeutic purpose.
No
Explanation: The device is an intramedullary implant system for fracture fixation, not for diagnosing medical conditions. Its intended use is treatment, not diagnosis.
No
The device description explicitly states that the system consists of implantable components (intramedullary nails) and instrumentation, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of diaphyseal fractures of long bones. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is an intramedullary implant system (nails) used for fracture fixation. This is a physical implant used in surgery, not a test performed on biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to fix broken bones.
N/A
Intended Use / Indications for Use
The MJ-FLEX THE NEW METAIZEAU NAIL™ is intended for the treatment of diaphyseal fractures of long bones.
The MJ-FLEX THE NEW METAIZEAU NAIL™ is indicated to treat:
- upper extremity and clavicle fractures in all patients except newborns and infants;
- lower extremity fractures in pediatric patients, except newborns and infants, where the flexibility of the implant is paramount not to disrupt the growth plate;
- lower extremity fractures in small adults where the medullary canal is narrow.
Product codes
HTY
Device Description
The Orthofix MJ-FLEX THE NEW METAIZEAU NAIL™ is an intramedullary implant system specifically designed for Elastic Stable Intramedullary Nailing (ESIN) fracture fixation.
The System consists of implantable components (intramedullary nails) and instrumentation. Nails are supplied in different diameters and lengths, in order to assure compatibility with patient anatomy, and in both Titanium alloy and Stainless Steel materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
diaphyseal fractures of long bones.
upper extremity and clavicle fractures
lower extremity fractures
Indicated Patient Age Range
all patients except newborns and infants; pediatric patients, except newborns and infants; small adults
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
The potential hazards have been evaluated and controlled through a Risk Management Plan.
All testing met or exceeded the requirements as established by the test protocols and applicable standards. A review of the mechanical data indicates that the components of the Subject device are capable of withstanding expected loads without failure. The Subject device was therefore found to be substantially equivalent to the Predicates. Clinical data was not needed to support the safety and effectiveness of the Subject Device.
The following mechanical testing was performed:
• ASTM F 1264-16e1 "Standard Specification and Test Method for Intramedullary Fixation Devices"
Furthermore, bacterial endotoxin testing was conducted on the Subject Device, and was found to meet the expected endotoxin limits.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. 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" in blue, with "ADMINISTRATION" underneath.
November 16, 2017
Orthofix Srl % Chery Wagoner Consultant Wagoner Consulting LLC PO Box 15729 Wilmington, North Carolina 24408
Re: K173051
Trade/Device Name: Orthofix MJ-FLEX THE NEW METAIZEAU NAIL Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTY Dated: September 8, 2017 Received: September 28, 2017
Dear Chery Wagoner:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Chery Wagoner
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Orthofix MJ-Flex The New Metazeau Nail
Indications for Use (Describe) The MJ-FLEX THE NEW METAIZEAU NAIL™ is intended for the treatment of diaphyseal fractures of long bones.
The MJ-FLEX THE NEW METAIZEAU NAIL™ is indicated to treat:
-
upper extremity and clavicle fractures in all patients except newborns and infants;
-
lower extremity fractures in pediatic patients, except newborns and infants, where the flexibility of the implant is
paramount not to disrupt the growth plate;
- lower extremity fractures in small adults where the medullary canal is narrow.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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."
3
Image /page/3/Picture/1 description: The image shows the logo for Orthofix, a medical device company. Below the logo is the text "510(k) Summary (as required by 21 CFR 807.92)". The logo consists of the word "ORTHOFIX" in bold, black letters, with a registered trademark symbol next to it. Above the word is a blue, abstract shape.
| Submitter | Orthofix Srl |
|---|---|
| Via delle Nazioni, 9 37012 Bussolengo (VR) - Italy | |
| Telephone | + 39 045 6719.000 |
| Fax | + 39 045 6719.380 |
| Contact Person | Gianluca Ricadona
Sr. Quality and Regulatory Affairs Manager |
|----------------|-----------------------------------------------------------------|
| Address | Via delle Nazioni, 9
37012 Bussolengo (VR) - Italy |
| Telephone | + 39 045 6719.000 |
| Fax | + 39 045 6719.380 |
| email | gianlucaricadona@orthofix.com |
| Date Prepared | September 8th, 2017 |
| Trade Name | Orthofix MJ-FLEX THE NEW METAIZEAU NAIL™ |
|---|---|
| Common Name | Pin, fixation, smooth |
| Panel Code | Orthopaedics/87 |
| Classification | |
| Name | Smooth or threaded metallic bone fastener |
| Class | Class II |
| Requlation | |
| Number | 21 CFR 888.3040 |
| Product Code | HTY |
| Predicate Device Name | 510(k) Number | Manufacturer |
|---|---|---|
| OrthoPediatrics PediFlex™ Flexible Nail System | K082375 | Orthopediatrics |
| Description | The Orthofix MJ-FLEX THE NEW METAIZEAU NAIL™ is an intramedullary implant system specifically designed for Elastic Stable Intramedullary Nailing (ESIN) fracture fixation. |
|---|---|
| The System consists of implantable components (intramedullary nails) and instrumentation. | |
| Nails are supplied in different diameters and lengths, in order to assure compatibility with patient anatomy, and in both Titanium alloy and Stainless Steel materials. |
| Indications
for
Use | The MJ-FLEX THE NEW METAIZEAU NAIL™ is intended for the
treatment of diaphyseal fractures of long bones.
The MJ-FLEX THE NEW METAIZEAU NAIL™ is indicated to treat:
- upper extremity and clavicle fractures in all patients except newborns
and infants; |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
4
| | - lower extremity fractures in pediatric patients, except newborns and
infants, where the flexibility of the implant is paramount not to disrupt the
growth plate;
- lower extremity fractures in small adults where the medullary canal is
narrow. |
|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics
and Substantial
Equivalence | Documentation was provided to demonstrate that the Orthofix MJ-FLEX
THE NEW METAIZEAU NAIL™ is substantially equivalent to the legally
marketed Predicate, OrthoPediatrics PediFlex™ Flexible Nail System
(K082375). Implants and accessories included in the Orthofix MJ-FLEX
THE NEW METAIZEAU NAIL™ and the predicate device are both Smooth
or threaded metallic bone fastener as defined in 21 CFR 888.3040. They
are both elastic nails for internal fixation. The Orthofix MJ-FLEX THE NEW
METAIZEAU NAIL™ is substantially equivalent to the predicate device in
indications for use, site of application, patient population, conditions of
use, mechanical performances, basic design, operating principles,
materials. The Orthofix MJ-FLEX THE NEW METAIZEAU NAIL™ is
similar to its predicate in size and range of variants. Testing in accordance
with ASTM F 1264 shows the mechanical strength of the subject device
to be equivalent or better than the predicate devices. |
| -------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
| Performance Data | The potential hazards have been evaluated and controlled through a Risk
Management Plan. |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | All testing met or exceeded the requirements as established by the test
protocols and applicable standards. A review of the mechanical data
indicates that the components of the Subject device are capable of
withstanding expected loads without failure. The Subject device was
therefore found to be substantially equivalent to the Predicates. Clinical
data was not needed to support the safety and effectiveness of the
Subject Device.
The following mechanical testing was performed:
• ASTM F 1264-16e1 "Standard Specification and Test Method for
Intramedullary Fixation Devices" |
| | Furthermore, bacterial endotoxin testing was conducted on the Subject
Device, and was found to meet the expected endotoxin limits. |
| Conclusion | Based on design, materials, indications for use, technological
characteristics, and comparison to predicate devices, the Subject Orthofix
MJ-FLEX THE NEW METAIZEAU NAIL™ has been shown to be
substantially equivalent to legally marketed predicate device, and is safe
and effective for its intended use. |