(242 days)
The ORTHOFIX CHIMAERA Hip Fracture System – trochanteric nailing system is intended for insertion into the medullary canal of a femur for the alignment, stabilization of various types of fractures or deformities.
The ORTHOFIX CHIMAERA Hip Fracture System - trochanteric nailing system is indicated for treatment of stable and unstable pertrochanteric, intertrochanteric fractures of the femur alone or when these fractures occur in combination with shaft fractures extending distally to a point approximal to the intercondylar notch. These includes traumatic fractures, re-fractures, non-union, reconstruction, malalignment, pathological fractures and impending pathological fractures.
The ORTHOFIX CHIMAERA Hip Fracture System – Trochanteric Nailing System consists of implantable components (nails, end caps and screws) and instrumentation.
The proximal part of the nail features a threaded bore to connect the nail to the targeting handle by means of a cannulated bolt. The insertion of the nail into the femur medullary canal is typically performed by some instruments, including: guide wire, awl, reamer and impactor elements.
This document is a 510(k) summary for the Orthofix CHIMAERA Hip Fracture System - Trochanteric Nailing System. It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
For the Orthofix CHIMAERA Hip Fracture System, the acceptance criteria are based on mechanical performance and biocompatibility. The reported device performance indicates that the device met these criteria.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Withstand expected loads without failure. | All testing met or exceeded the requirements as established by the test protocols and applicable standards. The components of the Subject device are capable of withstanding expected loads without failure. The mechanical properties of the subject device are equivalent or better than the predicate devices. |
| Biocompatibility | Non-pyrogenicity (absence of bacterial endotoxins). | Additional tests were performed to establish non-pyrogenicity, which likely met the standards as the conclusion states substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention "test set" in the context of clinical trials with human subjects. Instead, it refers to mechanical testing and biocompatibility testing.
- Mechanical Testing: The sample sizes for the mechanical tests (e.g., endurance properties, fracture fixation device testing, intramedullary fixation device testing) are not explicitly stated in the provided text. These tests are performed on device components, not human subjects, so the concept of "data provenance" (country of origin, retrospective/prospective) as it applies to clinical data is not applicable. The tests are conducted in a controlled laboratory environment.
- Biocompatibility Testing: Similar to mechanical testing, specific sample sizes for tests like "Bacterial endotoxin test (LAL)" are not provided. These tests are also laboratory-based.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this 510(k) submission. This submission focuses on demonstrating substantial equivalence through mechanical and biocompatibility testing, not on clinical performance or diagnostic accuracy that would require expert-established ground truth. There is no mention of a "test set" in the context of expert review for establishing ground truth.
4. Adjudication Method for the Test Set
This information is not applicable. As stated above, this submission relies on laboratory-based tests (mechanical and biocompatibility) rather than a clinical "test set" that would involve expert adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the Subject Device."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a hip fracture system (implants and instrumentation), not an AI algorithm or a diagnostic tool. Therefore, the concept of "standalone algorithm performance" is irrelevant.
7. Type of Ground Truth Used
For the mechanical and biocompatibility testing, the "ground truth" is established by the standards and protocols against which the device is tested.
- Mechanical Performance: The "ground truth" is defined by the requirements outlined in standards such as ISO 7206-4, ISO 12107, ASTM F384-12, and ASTM F1264-14. The device is expected to meet or exceed these established performance benchmarks.
- Biocompatibility: The "ground truth" for non-pyrogenicity is defined by the criteria within standards like USP 38: 2014 <85>, USP 38: 2014 <161>, and ANSI/AAMI ST72: 2011.
8. Sample Size for the Training Set
This information is not applicable. The device is a mechanical implant system, not a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As the device is not a machine learning model, there is no "training set" or corresponding ground truth to be established in that context.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 24, 2017
Orthofix Srl % Cheryl Wagoner Consultant Wagoner Consulting LLC PO Box 15729 Wilmington, North Carolina 28408
Re: K161466
Trade/Device Name: ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: December 23, 2016 Received: December 27, 2016
Dear Cheryl 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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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Indications for Use
510(k) Number (if known) K161466
Device Name
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
Indications for Use (Describe)
The ORTHOFIX CHIMAERA Hip Fracture System – trochanteric nailing system is intended for insertion into the medullary canal of a femur for the alignment, stabilization of various types of fractures or deformities.
The ORTHOFIX CHIMAERA Hip Fracture System - trochanteric nailing system is indicated for treatment of stable and unstable pertrochanteric, intertrochanteric fractures of the femur alone or when these fractures occur in combination with shaft fractures extending distally to a point approximal to the intercondylar notch. These includes traumatic fractures, re-fractures, non-union, reconstruction, malalignment, pathological fractures and impending pathological fractures.
| 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)
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Attachment 7
Image /page/3/Picture/2 description: The image shows the logo for ORTHOFIX, followed by the text "510(k) Summary" and the number K161466. The ORTHOFIX logo is a blue symbol above the company name, which is written in bold, black letters. The text is centered on a white background.
(as required by 21 CFR 807.92)
| Submitter Name | Orthofix Srl |
|---|---|
| Address | Via delle Nazioni, 9 37012 Bussolengo (VR) - Italy |
| Telephone | + 39 045 6719.000 |
| Fax | + 39 045 6719.380 |
| Contact Person | Gianluca RicadonaSr. Quality & Regulatory Affairs Manager |
|---|---|
| Address | Via delle Nazioni, 937012 Bussolengo (VR) - Italy |
| Telephone | + 39 045 6719 000 |
| Fax | + 39 045 6719 380 |
| GianlucaRicadona@orthofix.it | |
| Date Prepared | May 26, 2016 |
| Trade Name | ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System |
|---|---|
| Common Name | Rod, fixation, intramedullary and accessories |
| Panel Code | Orthopedic |
| Classification Name | Intramedullary fixation rod. |
| Class | Class II |
| Regulation Number | 21 CFR 888.3020 |
| Product Code | HSB |
| PrimaryPredicate | Predicate Device Name | 510(k) | Manufacturer |
|---|---|---|---|
| √ | Orthofix Titanium Nailing System(VeroNail) | K053261 | Orthofix Srl |
| Gamma3 Nail System | K043431 | HowmedicaOsteonics Corp. |
| Device description | The ORTHOFIX CHIMAERA Hip Fracture System – TrochantericNailing System consists of implantable components (nails, end capsand screws) and instrumentation.The proximal part of the nail features a threaded bore to connect thenail to the targeting handle by means of a cannulated bolt. Theinsertion of the nail into the femur medullary canal is typicallyperformed by some instruments, including: guide wire, awl, reamerand impactor elements. |
|---|---|
| Intended Use andIndications | The ORTHOFIX CHIMAERA Hip Fracture System – TrochantericNailing System is intended for insertion into the medullary canal of afemur for the alignment, stabilization and fixation of various types offractures or deformities.The ORTHOFIX CHIMAERA Hip Fracture System – Trochanteric |
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| Nailing System is indicated for treatment of stable and unstablepertrochanteric, intertrochanteric and subtrochanteric fractures of thefemur alone or when these fractures occur in combination with shaftfractures, or when these fractures occur in combination with shaftfractures extending distally to a point approximately 10 cm proximal tothe intercondylar notch. |
|---|
| These includes traumatic fractures, re-fractures, non-union,reconstruction, malunion, malalignment, pathological fractures andimpending pathological fractures. |
| TechnologicalCharacteristics andSubstantialEquivalence | Documentation was provided to demonstrate that the ORTHOFIXCHIMAERA Hip Fracture System - Trochanteric Nailing System issubstantially equivalent to the legally marketed predicates.Components and instrumentation included in the ORTHOFIXCHIMAERA Hip Fracture System - Trochanteric Nailing Systemand the predicate devices are all internal fracture fixation systems,as defined in 21 CFR 888.3020. The ORTHOFIX CHIMAERA HipFracture System - Trochanteric Nailing System is substantiallyequivalent to the predicate devices in: intended use, site ofapplication, patient population, conditions of use, mechanicalperformances, operating principles and materials. The ORTHOFIXCHIMAERA Hip Fracture System - Trochanteric Nailing System iscomparable to its predicate in dimensions and materials.Mechanical testing show how the mechanical properties of thesubject device are equivalent or better than the predicate devices. |
|---|---|
| Performance Data | The potential hazards have been evaluated and controlled througha Risk Management Plan.All testing met or exceeded the requirements as established by thetest protocols and applicable standards. A review of the mechanicaldata indicates that the components of the Subject device arecapable of withstanding expected loads without failure. The Subjectdevice was therefore found to be substantially equivalent to thepredicate devices. Clinical data was not needed to support thesafety and effectiveness of the Subject Device.Mechanical testing was performed according to the followingstandards:• ISO 7206-4 "Implants for surgery - Partial and total hip jointprostheses - Part 4: Determination of endurance propertiesand performance of stemmed femoral components".• ISO 12107 "Metallic materials - Fatigue testing - Statisticalplanning and analysis of data".• ASTM F384-12 "Standard Specifications and Test Methods forMetallic Angled Orthopedic Fracture Fixation Devices".• ASTM F1264-14 "Standard Specification and Test Methods forIntramedullary Fixation Devices". |
| Biocompatibilitydata | In order to establish non-pyrogenicity of the Subject device,additional tests were performed according to the followinginternational standard:• USP 38: 2014 < 85 > "Bacterial endotoxin test (LAL)".• USP 38: 2014 < 161 > "Medical devices – bacterial endotoxinand pyrogen tests".• ANSI / AAMI ST72: 2011 "Bacterial endotoxins - Testmethodologies. routine monitoring and alternative batch |
| testing". | |
| • FDA 2012 Q&A "Guidance for Industry Pyrogen andEndotoxins Testing: Question and Answers". | |
| Here below the tests references list: | |
| • Validation report 16VA00533 | |
| • Test report Cert_2016_7505 | |
| • Test report Cert_2016_7506 | |
| • Test report Cert_2016_7507. | |
| Conclusion | Based upon similarities in: intended use, site of application, patientpopulation, conditions of use, mechanical performances, operatingprinciples, materials and for the results of mechanical testing,ORTHOFIX CHIMAERA Hip Fracture System – Trochanteric NailingSystem has been shown to be substantially equivalent to the legallymarketed predicate devices. |
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§ 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.