ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System

K161466 · Orthofix Srl · HSB · Jan 24, 2017 · Orthopedic

Device Facts

• Record ID: K161466
• Device Name: ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
• Applicant: Orthofix Srl
• Product Code: HSB · Orthopedic
• Decision Date: Jan 24, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Intramedullary fixation system for femoral fractures; consists of titanium nails, end caps, and screws; used with surgical instrumentation (guide wires, awls, reamers, impactors). Surgeon inserts nail into femoral medullary canal to provide mechanical alignment and stabilization of fractures. Device provides internal fixation to facilitate bone healing; intended for use in clinical/OR settings by orthopedic surgeons. No software or electronic components.

Clinical Evidence

No clinical data. Safety and effectiveness supported by bench testing, including mechanical performance testing (fatigue, endurance) and biocompatibility/pyrogenicity testing per ISO and USP standards.

Technological Characteristics

Intramedullary fixation rod system. Materials: Titanium. Standards: ISO 7206-4 (endurance), ISO 12107 (fatigue), ASTM F384-12 (angled fixation), ASTM F1264-14 (intramedullary devices). Biocompatibility: USP <85>, USP <161>, ANSI/AAMI ST72. Mechanical fixation via nail, end cap, and screw components. No software or energy source.

Indications for Use

Indicated for patients with stable/unstable pertrochanteric, intertrochanteric, and subtrochanteric femoral fractures, including those with distal shaft fractures (up to 10cm proximal to intercondylar notch). Covers traumatic fractures, re-fractures, non-union, reconstruction, malunion, malalignment, pathological fractures, and impending pathological fractures.

Regulatory Classification

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.

Predicate Devices

• Orthofix Titanium Nailing System (VeroNail) (K053261)
• Gamma3 Nail System (K043431)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

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 [phone] or [phone] 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 [phone] or [phone] 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 Ricadona<br>Sr. Quality & Regulatory Affairs Manager |
|----------------|---------------------------------------------------------------|
| Address | Via delle Nazioni, 9<br>37012 Bussolengo (VR) - Italy |
| Telephone | + 39 045 6719 000 |
| Fax | + 39 045 6719 380 |
| email | [e-mail] |
| 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 |

| Primary<br>Predicate | Predicate Device Name | 510(k) | Manufacturer |
|----------------------|------------------------------------------------|---------|------------------------------|
| √ | Orthofix Titanium Nailing System<br>(VeroNail) | K053261 | Orthofix Srl |
| | Gamma3 Nail System | K043431 | Howmedica<br>Osteonics Corp. |

| Device description | The ORTHOFIX CHIMAERA Hip Fracture System – Trochanteric<br>Nailing System consists of implantable components (nails, end caps<br>and screws) and instrumentation.<br>The proximal part of the nail features a threaded bore to connect the<br>nail to the targeting handle by means of a cannulated bolt. The<br>insertion of the nail into the femur medullary canal is typically<br>performed by some instruments, including: guide wire, awl, reamer<br>and impactor elements. |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use and<br>Indications | The ORTHOFIX CHIMAERA Hip Fracture System – Trochanteric<br>Nailing System is intended for insertion into the medullary canal of a<br>femur for the alignment, stabilization and fixation of various types of<br>fractures or deformities.<br>The ORTHOFIX CHIMAERA Hip Fracture System – Trochanteric |

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| Nailing System is indicated for treatment of stable and unstable<br>pertrochanteric, intertrochanteric and subtrochanteric fractures of the<br>femur alone or when these fractures occur in combination with shaft<br>fractures, or when these fractures occur in combination with shaft<br>fractures extending distally to a point approximately 10 cm proximal to<br>the intercondylar notch. |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| These includes traumatic fractures, re-fractures, non-union,<br>reconstruction, malunion, malalignment, pathological fractures and<br>impending pathological fractures. |

| Technological<br>Characteristics and<br>Substantial<br>Equivalence | Documentation was provided to demonstrate that the ORTHOFIX<br>CHIMAERA Hip Fracture System - Trochanteric Nailing System is<br>substantially equivalent to the legally marketed predicates.<br>Components and instrumentation included in the ORTHOFIX<br>CHIMAERA Hip Fracture System - Trochanteric Nailing System<br>and the predicate devices are all internal fracture fixation systems,<br>as defined in 21 CFR 888.3020. The ORTHOFIX CHIMAERA Hip<br>Fracture System - Trochanteric Nailing System is substantially<br>equivalent to the predicate devices in: intended use, site of<br>application, patient population, conditions of use, mechanical<br>performances, operating principles and materials. The ORTHOFIX<br>CHIMAERA Hip Fracture System - Trochanteric Nailing System is<br>comparable to its predicate in dimensions and materials.<br>Mechanical testing show how the mechanical properties of the<br>subject device are equivalent or better than the predicate devices. |
|--------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data | The potential hazards have been evaluated and controlled through<br>a Risk Management Plan.<br>All testing met or exceeded the requirements as established by the<br>test protocols and applicable standards. A review of the mechanical<br>data indicates that the components of the Subject device are<br>capable of withstanding expected loads without failure. The Subject<br>device was therefore found to be substantially equivalent to the<br>predicate devices. Clinical data was not needed to support the<br>safety and effectiveness of the Subject Device.<br>Mechanical testing was performed according to the following<br>standards:<br>• ISO 7206-4 "Implants for surgery - Partial and total hip joint<br>prostheses - Part 4: Determination of endurance properties<br>and performance of stemmed femoral components".<br>• ISO 12107 "Metallic materials - Fatigue testing - Statistical<br>planning and analysis of data".<br>• ASTM F384-12 "Standard Specifications and Test Methods for<br>Metallic Angled Orthopedic Fracture Fixation Devices".<br>• ASTM F1264-14 "Standard Specification and Test Methods for<br>Intramedullary Fixation Devices". |
| Biocompatibility<br>data | In order to establish non-pyrogenicity of the Subject device,<br>additional tests were performed according to the following<br>international standard:<br>• USP 38: 2014 < 85 > "Bacterial endotoxin test (LAL)".<br>• USP 38: 2014 < 161 > "Medical devices – bacterial endotoxin<br>and pyrogen tests".<br>• ANSI / AAMI ST72: 2011 "Bacterial endotoxins - Test<br>methodologies. routine monitoring and alternative batch |
| | testing". |
| | • FDA 2012 Q&A "Guidance for Industry Pyrogen and<br>Endotoxins 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, patient<br>population, conditions of use, mechanical performances, operating<br>principles, materials and for the results of mechanical testing,<br>ORTHOFIX CHIMAERA Hip Fracture System – Trochanteric Nailing<br>System has been shown to be substantially equivalent to the legally<br>marketed predicate devices. |

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