TrueLok Evo

{0}------------------------------------------------ November 5, 2021 Image /page/0/Picture/1 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. Orthofix SRL % Cheryl Wagoner Consultant Wagoner Consulting LLG PO Box 15729 Wilmington, North Carolina 28408 Re: K212044 Trade/Device Name: TrueLok™ Evo Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT, LXT Dated: September 24, 2021 Received: September 28, 2021 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K212044 Device Name TrueLok™ EVO Indications for Use (Describe) The TrueLokTM EVO is intended to provide bone fixation. The TrueLok™ EVO is indicated for fractures, pseudarthrosis / non-unions, joint arthrodesis and correction of bony or soft tissue deformities and defects (e.g. bone transport) in long bones and in the foot. | 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW * The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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" and the code "(21 CFR 807.92)". The logo consists of the word "ORTHOFIX" in bold, black letters, with a blue, curved shape above it. #### Submitter information | 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 address | GianlucaRicadona@orthofix.it | | Date of preparation | September 14, 2021 | ## Trade Name, Common Name, Classification | Trade Name | TrueLok™ EVO | |------------------------|--------------------------------------------------------------------------------| | Device | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple<br>Component | | Primary Product code | KTT, LXT | | Panel Code | Orthopedic | | Class | Class II | | Regulation Number | 21 CFR 888.3030 | | Regulation description | Single/multiple component metallic bone fixation appliances<br>and accessories | ## Predicate devices and reference devices | Primary Predicate Devices | 510(k) Number | Manufacturer | |------------------------------------------------------|---------------------------------|------------------| | TRUE LOK MONOLATERAL/BILATERAL FIXATOR | K941048 | Orthofix S.r.l. | | Reference Device | | | | Orthofix TL-HEX True Lok Hexapod System (TL-HEX) | K152171 | Orthofix S.r.l. | | ORTHOFIX MODULAR SYSTEM | K944092/<br>K955848/<br>K974186 | Orthofix S.r.l. | | DePuy Synthes MAXFRAME Multi-Axial Correction System | K161417 | Synthes USA, LLC | | Device description | The TrueLok™ EVO system is a modular circular external fixation | |------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | system based on Ilizarov fixation apparatus principles. | | | The TrueLok™ consists of external supports (rings and | | | footplates), variable length struts and a variety of connection | | | elements that build the external frame. | | | The TrueLok™ external frame is secured by using the Orthofix | | | predicates pin and wires. The Subject external support | | | components (rings, footplates and struts), are made from AISI<br>316LVM, AISI 630, Aluminum alloy (EN-AW 6082 T6) and Epoxy<br>carbon fiber. | | | Application and removal of the TL-EVO can be performed with<br>Orthofix general orthopedic instrumentation. | | | TrueLokTM EVO fixator components are provided in single-use<br>sterile configuration and they are available as single component<br>packaged in double pouches or in multiple components<br>packaged in double rigid blister. | | Indications for use | The TrueLok™ EVO is intended to provide bone fixation. | | | The TrueLok ™ EVO is indicated for fractures, pseudarthrosis /<br>non-unions, lengthening, joint arthrodesis and correction of bony<br>or soft tissue deformities and defects (e.g. bone transport) in long<br>bones and in the foot. | | Technological<br>Characteristics and<br>Intended Use | The Subject device fundamental scientific principles and<br>technological characteristic, including: the intended use, material<br>and general design, are the same as, or similar to, the chosen<br>predicate devices. | | | Summary of the technological characteristics and Intended Use: | | | ✓ Intended use: identical for bone fixation. | | | ✓ Indications for Use, Anatomical sites, operating principles<br>and conditions of use: are substantially equivalent to the<br>more extensive application of indications of the predicates;<br>no new risks associated to the Subject device compared to<br>those of the Primary predicates and the additional predicate<br>device which have same indications for use, anatomical sites<br>and conditions of use. Verification activities on Subject<br>devices demonstrated the same safety and effectiveness<br>performs equivalent to the predicate devices. | | | ✓ Geometry and size: similar sizes and geometry of the<br>predicates external components; similar sizes and geometry<br>of the predicate bone screws. | | | ✓ Sterilization, same method as the predicates.<br>The technological characteristics of the TrueLok™ EVO are<br>substantially equivalent to the predicate devices. | | Performance<br>Analysis | Subject device has similar configuration, sizes and design as the<br>predicate devices.<br>Performance data was provided in support of the substantial<br>equivalence determination for Magnetic Resonance Imaging<br>(MRI) with respect to the reference predicate device.<br>MRI compatibility testing/assessment was conducted as per the<br>FDA's guidance<br>"Establishing Safety and Compatibility of Passive Implants in<br>the Magnetic Resonance (MR) Environment", December 11,<br>2014 and the standards listed below:<br>1. Magnetically induced displacement force (ASTM F2052)<br>2 Magnetically induced torque (ASTM F2213) | | | 3. Radiofrequency (RF) induced heating (ASTM F2182)<br>4. MR image artifact (ASTM F2119)<br>In summary, MR safety testing/assessment supports the<br>appropriate MR parameters and symbols found in the subject<br>device labeling. | | | Performance mechanical testing on Subject components item<br>have been performed according to: ASTM F1541-17 Standard<br>Specification and Test Methods for External Skeletal Fixation<br>Devices. | | | Results to support the determination of substantial equivalence<br>from testing and engineering assessments on worst cases of<br>Subject device and corresponding predicate devices and other<br>similar devices, confirm that Subject device, as safe, as<br>effective, and performs as well as or better than the predicate<br>devices.<br>Any potential hazards have been evaluated and controlled<br>through Risk Management activities, and any relevant<br>information, have been addressed in the labelling, after all<br>control measures have been implemented.<br>The review of the current clinical literature on the predicates and<br>on other similar devices have been conducted to support the<br>clinical indications of TrueLok™ EVO without requiring further<br>clinical data. | | Conclusion | Based upon equivalences in: intended use, site of application,<br>conditions of use, operating principles, and the non-clinical<br>performance data, the TrueLok™ EVO has been shown to be<br>safe and effective, and to perform equivalently as compared to<br>the legally marketed predicate devices.<br>Therefore, the Subject device is substantially equivalent to the<br>legally marketed predicate devices. | {4}------------------------------------------------ {5}------------------------------------------------