Agile Nail

K172699 · Orthofix Srl · HSB · Apr 23, 2018 · Orthopedic

Device Facts

• Record ID: K172699
• Device Name: Agile Nail
• Applicant: Orthofix Srl
• Product Code: HSB · Orthopedic
• Decision Date: Apr 23, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Agile Nail is intended for insertion in the medullary canal of a femur for the alignment and the stabilization of fractures, and for the correction of deformities. It is indicated for the treatment of subtrochanteric fractures and of femoral shaft fractures, with the exception of newborns and infants, and in adult patients with an appropriate medullary canal. The indications include: prophylactic nailing of impending pathologic fractures; fixation of femurs that have been surgically prepared (osteotomy); nonunions and malunions; reconstruction following tumor resection and grafting and bone lengthening and shortening.

Device Story

Agile Nail system comprises ante grade intramedullary nails, end caps, and screws; includes instrumentation for insertion and extraction. Used by orthopedic surgeons in clinical settings for femoral fracture stabilization and deformity correction. Device inserted into medullary canal to provide mechanical alignment and fixation. System supports various clinical scenarios including pathologic fractures, osteotomies, nonunions, malunions, and tumor-related reconstructions. Benefits include restoration of bone stability and alignment, facilitating healing. No software or AI components involved.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F1264-16 and ASTM F543-17. Biocompatibility and non-pyrogenicity established via USP 38 <85>, USP 38 <161>, and ANSI/AAMI ST72:2011. No clinical data provided.

Technological Characteristics

Intramedullary fixation rod system. Materials are metallic (implied by bone screw standards). Mechanical testing conducted per ASTM F1264-16 (intramedullary fixation devices) and ASTM F543-17 (metallic bone screws). No software, electronics, or energy sources.

Indications for Use

Indicated for pediatric (excluding newborns/infants) and adult patients with appropriate medullary canal for treatment of subtrochanteric and femoral shaft fractures, prophylactic nailing of impending pathologic fractures, fixation of surgically prepared femurs (osteotomy), nonunions, malunions, and reconstruction following tumor resection, grafting, and bone lengthening/shortening.

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

• Synthes Adolescent Lateral Entry Femoral Nail System (K070843)
• Orthopediatrics PediNal Intramedullary Nailing System (K083726)

Submission Summary (Full Text)

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Orthofix Srl % Cheryl Wagoner Consultant Wagoner Consulting LLC PO Box 15729 Wilmington, North Carolina 24408

Re: K172699

Trade/Device Name: Agile Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: March 23, 2018 Received: March 26, 2018

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 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);

April 23, 2018

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

## Katherine D. Kavlock -S

for 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) K172699

Device Name Agile Nail

Indications for Use (Describe)

The Agile Nail is intended for insertion in the medullary canal of a femur for the alignment and the stabilization of fractures, and for the correction of deformities.

It is indicated for the treatment of subtrochanteric fractures and of femoral shaft fractures, with the exception of newborns and infants, and in adult patients with an appropriate medullary canal.

The indications include:

prophylactic nailing of impending pathologic fractures;

fixation of femurs that have been surgically prepared (osteotomy);

nonunions and malunions;

reconstruction following tumor resection and grafting and bone lengthening and shortening.

| 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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Image /page/3/Picture/0 description: The image shows the Orthofix logo, which is a blue abstract shape above the word "ORTHOFIX" in black, with a registered trademark symbol. Below the logo is the text "510(k) Summary" in a smaller font size. The text "(as required by 21 CFR 807.92)" is below the summary in an even smaller font size.

| 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 | August 29, 2017 | | |
| Trade Name | Agile Nail | | |
| 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 | | |
| Predicate Device Name | 510(k) Number | Manufacturer | |
| Synthes Adolescent Lateral Entry<br>Femoral Nail System | K070843 | Synthes(USA) | |
| Orthopediatrics PediNal Intramedullary<br>Nailing System | K083726 | Orthopediatrics, Corp. | |
| Device description | The Agile Nail consists of ante grade intramedullary nails, end caps and screws, and related instrumentation for insertion and extraction of the implantable components.<br>The System is designed to address femoral fractures and deformity corrections procedures. | | |
| Indications for use | The Agile Nail is intended for insertion in the medullary canal of a femur for the alignment and the stabilization of fractures, and for the correction of deformities.<br>It is indicated for the treatment of subtrochanteric fractures and of femoral shaft fractures, in pediatric patients, with the exception of newborns and infants, and in adult patients with an appropriate medullary canal.<br>The indications include:<br>prophylactic nailing of impending pathologic fractures;<br>fixation of femurs that have been surgically prepared (osteotomy);<br>nonunions and malunions;<br>reconstruction following tumor resection and grafting and bone lengthening and shortening. | | |

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| Technological<br>Characteristics and<br>Substantial<br>Equivalence | Documentation was provided to demonstrate that the Agile Nail<br>is substantially equivalent to the legally marketed predicates.<br>Components included in the Subject system and the predicates<br>are all dedicated to internal fracture fixation procedure, as<br>defined in 21 CFR 888.3020.<br>The Agile Nail is substantially equivalent to the predicate<br>devices in: intended use, site of application, patient population,<br>conditions of use, mechanical performances, operating<br>principles and materials. Mechanical testing demonstrate how<br>the mechanical properties of the Subject Device are equivalent /<br>better than the predicate involved. |
|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data | The potential hazards have been evaluated and controlled<br>through a Risk Management Plan. |
| | All testing met or exceeded the requirements as established by<br>the test protocols and applicable standards. |
| | A review of the mechanical data indicates that the components<br>of the Subject device are capable of withstanding expected<br>loads without failure. The Agile Nail was therefore found to be<br>substantially equivalent to the predicate involved in the<br>performance.<br>Clinical data were not needed to support the safety and<br>effectiveness of the Subject Device. |
| | Mechanical testing were performed according to the following<br>standards: |
| | ASTM F1264-16 "Standard Specification and Test Methods for<br>Intramedullary Fixation Devices". |
| | ASTM F543-17 "Standard Specification and Test Methods for<br>Metallic Medical Bone Screws." |
| Biocompatibility data | In order to establish the Subject device non-pyrogenicity, some<br>tests were performed on an equivalent System implants,<br>according to the following 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".<br>• FDA 2012 Q&A "Guidance for Industry Pyrogen and<br>Endotoxins Testing: Question and Answers".<br>Here below the test reports and test rationale references list:<br>• 166699_rep_fin dated 2016/10/07<br>• 166700_Report_final dated 2016/10/13<br>• 16VA00533 validation report dated 2016/10/13<br>• Cert_2016_7505, Cert_2016_7506, and Cert_2016_7507<br>report dated 2016/10/19<br>• AGILE_QE_RA03_R1 |
| Conclusion | Based upon similarities in: intended use, site of application,<br>conditions of use, operating principles and mechanical<br>performances, the Agile Nail has been shown to be substantially<br>equivalent to its legally marketed predicate devices. |