(49 days)
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.
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.
This document is a 510(k) summary for the Orthofix MJ-FLEX THE NEW METAIZEAU NAIL. It pertains to a medical device (bone fixation fastener), not an AI/ML powered device. As such, the typical acceptance criteria and study data requested for AI/ML devices are not applicable.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through mechanical testing and a comparison of design, materials, and indications for use.
Here's a breakdown of the requested information, adapted to what is available in the provided text:
Acceptance Criteria and Device Performance for Orthofix MJ-FLEX THE NEW METAIZEAU NAIL
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Mechanical Strength | ASTM F 1264-16e1 "Standard Specification and Test Method for Intramedullary Fixation Devices" | "The mechanical strength of the subject device to be equivalent or better than the predicate devices.""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." |
| Biocompatibility/Safety | Bacterial Endotoxin Limits | "bacterial endotoxin testing was conducted on the Subject Device, and was found to meet the expected endotoxin limits." |
| Substantial Equivalence | Comparison to Predicate Device (OrthoPediatrics PediFlex™ Flexible Nail System - K082375) in terms of: - Indications for Use - Site of application - Patient population - Conditions of use - Mechanical performances - Basic design - Operating principles - Materials - Size and range of variants | "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." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated in the document for the mechanical or endotoxin testing. These are typically material and device performance tests, not clinical studies with patient data.
- Data Provenance: Not applicable in the context of patient data, as the tests described are laboratory-based mechanical and chemical tests of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The ground truth for mechanical and endotoxin testing is established by scientific standards (e.g., ASTM F 1264-16e1) and laboratory procedures, not by expert consensus on clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a clinical study involving human interpretation or adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable, as this is not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is not an AI/ML powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For mechanical performance: The ground truth is defined by the technical specifications and performance requirements outlined in the ASTM F 1264-16e1 standard.
- For biocompatibility: The ground truth is defined by the limits for bacterial endotoxin established by regulatory guidelines.
8. The sample size for the training set
- Not applicable, as this is not an AI/ML powered device, and therefore no "training set" in the machine learning sense exists.
9. How the ground truth for the training set was established
- Not applicable.
Summary of the Study Provided:
The study described is a premarket notification (510(k)) submission to the FDA, demonstrating the substantial equivalence of the Orthofix MJ-FLEX THE NEW METAIZEAU NAIL to a legally marketed predicate device (OrthoPediatrics PediFlex™ Flexible Nail System - K082375).
The study primarily consisted of non-clinical performance testing, specifically:
- Mechanical Testing: Performed according to ASTM F 1264-16e1 "Standard Specification and Test Method for Intramedullary Fixation Devices." The results indicated that the subject device's mechanical strength was equivalent to or better than the predicate devices and capable of withstanding expected loads without failure.
- Bacterial Endotoxin Testing: This testing was conducted to ensure the device's safety from endotoxin contamination, and it met the expected limits.
Clinical data was explicitly stated as "not needed to support the safety and effectiveness of the Subject Device," as substantial equivalence was demonstrated through non-clinical means. This type of submission relies on proving that the new device is as safe and effective as a device already on the market, based on similarities in design, materials, performance, and intended use.
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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);
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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
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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.
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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 RicadonaSr. Quality and Regulatory Affairs Manager |
|---|---|
| Address | Via delle Nazioni, 937012 Bussolengo (VR) - Italy |
| Telephone | + 39 045 6719.000 |
| Fax | + 39 045 6719.380 |
| 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 |
| ClassificationName | Smooth or threaded metallic bone fastener |
| Class | Class II |
| RequlationNumber | 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. |
| IndicationsforUse | The MJ-FLEX THE NEW METAIZEAU NAIL™ is intended for thetreatment 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 newbornsand infants; |
|---|---|
| --------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| - lower extremity fractures in pediatric patients, except newborns andinfants, where the flexibility of the implant is paramount not to disrupt thegrowth plate;- lower extremity fractures in small adults where the medullary canal isnarrow. | |
|---|---|
| -- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| TechnologicalCharacteristicsand SubstantialEquivalence | Documentation was provided to demonstrate that the Orthofix MJ-FLEXTHE NEW METAIZEAU NAIL™ is substantially equivalent to the legallymarketed Predicate, OrthoPediatrics PediFlex™ Flexible Nail System(K082375). Implants and accessories included in the Orthofix MJ-FLEXTHE NEW METAIZEAU NAIL™ and the predicate device are both Smoothor threaded metallic bone fastener as defined in 21 CFR 888.3040. Theyare both elastic nails for internal fixation. The Orthofix MJ-FLEX THE NEWMETAIZEAU NAIL™ is substantially equivalent to the predicate device inindications for use, site of application, patient population, conditions ofuse, mechanical performances, basic design, operating principles,materials. The Orthofix MJ-FLEX THE NEW METAIZEAU NAIL™ issimilar to its predicate in size and range of variants. Testing in accordancewith ASTM F 1264 shows the mechanical strength of the subject deviceto be equivalent or better than the predicate devices. |
|---|---|
| -------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Performance Data | The potential hazards have been evaluated and controlled through a RiskManagement Plan. |
|---|---|
| All testing met or exceeded the requirements as established by the testprotocols and applicable standards. A review of the mechanical dataindicates that the components of the Subject device are capable ofwithstanding expected loads without failure. The Subject device wastherefore found to be substantially equivalent to the Predicates. Clinicaldata was not needed to support the safety and effectiveness of theSubject Device.The following mechanical testing was performed:• ASTM F 1264-16e1 "Standard Specification and Test Method forIntramedullary Fixation Devices" | |
| Furthermore, bacterial endotoxin testing was conducted on the SubjectDevice, and was found to meet the expected endotoxin limits. | |
| Conclusion | Based on design, materials, indications for use, technologicalcharacteristics, and comparison to predicate devices, the Subject OrthofixMJ-FLEX THE NEW METAIZEAU NAIL™ has been shown to besubstantially equivalent to legally marketed predicate device, and is safeand effective for its intended use. |
§ 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.