Galaxy UNYCO System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Orthofix Srl % Ms. Cheryl Wagoner Consultant Wagoner Consulting LLC P.O. Box 15729 Wilmington, North Carolina 28408 Re: K170146 Trade/Device Name: Galaxy UNYCO System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: September 11, 2017 Received: September 12, 2017 Dear Ms. 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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov {1}------------------------------------------------ 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 (DICE) 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 (DICE) 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, Casey Hanley -S For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K170146 Device Name Galaxy UNYCO System Indications for Use (Describe) The Galaxy UNYCO System is intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment. Temporary stabilization of the femur, tibia and ankle in conditions and procedures, such as: - · comminuted open or closed fractures - · polytrauma patient - · damage control orthopedics for fractures with severe soft tissue injuries - · peri-prosthetic or peri-implant fractures - · joint dislocations, intra- and extra-articular injuries where spanning fixation is needed - · intra-operative fracture reduction - · intermediate stabilization in staged surgery - · infected non-union pending second stage treatment bone-loss or other reconstructive procedures. | Type of Use (Select one or both, as applicable) | <table><tr><td><label> <input checked="checked" type="checkbox"/> Reproductive Use (Part 31 CFR 321 Subpart B) </label></td><td><label> <input type="checkbox"/> One-Time Consumptive Use (31 CFR 321 Subpart C) </label></td></tr></table> | <label> <input checked="checked" type="checkbox"/> Reproductive Use (Part 31 CFR 321 Subpart B) </label> | <label> <input type="checkbox"/> One-Time Consumptive Use (31 CFR 321 Subpart C) </label> | |------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------| | <label> <input checked="checked" type="checkbox"/> Reproductive Use (Part 31 CFR 321 Subpart B) </label> | <label> <input type="checkbox"/> One-Time Consumptive Use (31 CFR 321 Subpart C) </label> | | | 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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(as required by 21 CFR 807.92) | 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<br>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 | GianlucaRicadona@orthofix.it | | Date Prepared | January 13, 2017 | | Trade Name | Galaxy UNYCO System | |---------------------|------------------------------------------------------------------------------| | Common Name | External Fixation Device and Accessories | | Panel Code | Orthopedic | | Classification Name | Single/multiple component metallic bone fixation appliances and accessories. | | Class | Class II | | Regulation Number | 21 CFR 888.3030 | | Product Code | KTT | | Predicate Device Name | 510(k) Number | Manufacturer | |-------------------------------------------------|---------------|--------------| | Synthes Large External Fixation, MR Conditional | K082650 | Synthes | | Galaxy Unyco System | K153233 | Orthofix Srl | | Description | The Galaxy UNYCO System consists of a series of sterile kits that<br>include clamps, rods, screws and specific application tools. An<br>external fixation system, as the subject device, is modular and so<br>different frame configurations are possible. The Orthofix components<br>in the Galaxy UNYCO System are not intended to replace normal<br>healthy bone or to withstand the stresses of weight bearing. The<br>Galaxy UNYCO System is compatible with Galaxy Fixation System<br>and bicortical screws. | |--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications and<br>Intended Use | The Galaxy UNYCO System is intended to be used for temporary<br>bone stabilization in trauma and orthopedic procedures of the lower<br>limb prior to definitive treatment.<br>Temporary stabilization of the femur, tibia and ankle in conditions and<br>procedures, such as:<br>• comminuted open or closed fractures<br>• polytrauma patient<br>• damage control orthopedics for fractures with severe soft tissue<br>injuries<br>• peri-prosthetic or peri-implant fractures | | | joint dislocations, intra- and extra-articular injuries where spanning fixation is needed intra-operative fracture reduction intermediate stabilization in staged surgery infected non-union pending second stage treatment bone-loss or other reconstructive procedures. | | Technological<br>Characteristics and<br>Substantial<br>Equivalence | Documentation was provided to demonstrate that the Galaxy Unyco System is substantially equivalent to the legally marketed predicates.<br>The devices and accessories included in the Galaxy Unyco System and the predicate devices are all external fracture fixation systems as defined in 21 CFR 888.3030. The Galaxy Unyco System is substantially equivalent to the predicate devices in intended use, site of application, patient population, conditions-of-use, mechanical performances, basic design, operating principles and materials. | | Performance Data | The potential hazards have been evaluated and controlled through a Risk Management Plan.<br>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 predicate devices. Clinical data was not needed to support the safety and effectiveness of the Subject Device.<br>Mechanical testing were performed in accordance to the following international standards: ASTM F1541 - 02e1 2011 "Standard Specification and Test Methods for External Skeletal Fixation Devices" ASTM F899 – 12b 2012 "Standard Specification for Stainless Steel for Surgical Instruments" ASTM F543-13e1 2013 "Standard Specification and Test Methods for Metallic Medical Bone Screws" | | Biocompatibility<br>Data | In order to address non-pyrogenicity of the Subject System, additional tests were performed according to the following standards and Guidance: USP 38: 2014 < 85 > "Bacterial endotoxin test (LAL)". USP 38: 2014 < 161 > "Medical devices – bacterial endotoxin and pyrogen tests". ANSI / AAMI ST72: 2011 "Bacterial endotoxins – Test methodologies, routine monitoring and alternative batch testing". "Guidance for Industry - Pyrogen and Endotoxins Testing: Question and Answers", issued by FDA on June 2012 | | Conclusion | Based on design, materials, intended use, technological characteristics and comparison to the predicates, Galaxy UNYCO femur and knee bridging has been shown to be substantially equivalent to legally marketed predicate devices. | {4}------------------------------------------------ ## Traditional 510(k) Premarket Notification Galaxy UNYCO System: femur and knee bridging