Fitbone Trochanteric

{0}------------------------------------------------ June 18, 2024 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION". Orthofix Srl Elvira Taccarelli Regulatory Affairs Manager Via delle Nazioni, 9 Bussolengo, 37012 Italy ## Re: K233867 Trade/Device Name: Fitbone Trochanteric Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: May 22, 2024 Received: May 22, 2024 Dear Elvira Taccarelli: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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). Sincerelv. Joseph P. Russell - Digitally signed by Joseph P. Russell -S S Date: 2024.06.18 10:51:53 -04'00" for: Farzana Sharmin, PhD 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 Submission Number (if known) K233867 Device Name Fitbone Trochanteric Indications for Use (Describe) Fitbone Trochanteric is indicated for limb lengthening of the femur. Fitbone Trochanteric is indicated for adult and pediatric (greater than 12 through 21 years of age) patients. Type of Use (Select one or both, as applicable) 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}------------------------------------------------ # ORTHOFIX® # 510(K) SUMMARY # ORTHOFIX SRL FITBONE™ TROCHANTERIC ## Submitter information | Company Name: | Orthofix S.r.l. | |---------------|-------------------------------------------------------| | Address | Via Delle Nazioni, 9<br>37012 Bussolengo (VR) - Italy | | Telephone | +39 045 6719000 | | Fax | +39 045 6719380 | | Contact Person | Elvira Taccarelli<br>Regulatory Affairs Manager | |----------------|-------------------------------------------------------| | Address | Via Delle Nazioni, 9<br>37012 Bussolengo (VR) - Italy | | Telephone | +39 045 6719000 | | Fax | +39 045 6719380 | | Email address | elvirataccarelli@orthofix.it | | Date prepared | 2024, June 17 | ### Trade Name, Common Name, Classification | Trade Name: | FITBONE® TROCHANTERIC | |----------------------|---------------------------------| | Common Name: | Intramedullary lengthening nail | | Classification Name: | Intramedullary fixation rod | | Requlation Number: | 21 CFR 888.3020 | | Product Code: | HSB | | Classification: | Class II | | Panel code: | Orthopedic | #### Primary predicate and additional reference devices | Primary Predicate | 510(k) Number | Manufacturer | |------------------------------------------------------------------------|---------------|------------------------------------------| | FITBONE® TAA | K203399 | Orthofix s.r.l. | | Reference Devices | 510(k) Number | Manufacturer | | PRECICE® Intramedullary Limb<br>Lengthening System | K220234 | NuVasive Specialized<br>Orthopedics Inc. | | Orthofix Modulsystem | K955848 | Orthofix s.r.l. | | RIVAL View Plating Systems and<br>Reduce Fracture Plating Systems | K190388 | | | JPS JuniOrtho Plating System | K200246 | | | Orthofix® External fixation Screw<br>(Pin) with Hydroxyapatite Coating | K974186 | | {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, sans-serif font. There is a registered trademark symbol to the right of the word "ORTHOFIX". | Device description | The FITBONE® Trochanteric is a fully implantable intramedullary lengthening nail<br>and accessories.<br>The subject FITBONE® Trochanteric consists of the implantable intramedullary<br>lengthening nail and accessories (Locking screws, Trial nails, K-wire and<br>Convenience kits). The Subject device is implanted into the medullary canal of the<br>femur and connected to the primary predicate intracutaneous Receiver (K163368)<br>by a bipolar feed line. The external FITBONE Control Set is the same as previously<br>cleared for the primary predicate Fitbone TAA device (K203399) and consists of a<br>control electronics station and transmitter. There are no changes to the previously | |--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | cleared Control Sets and Receiver as a result of this submission.<br>The power required for the distraction process is controlled by hermetically enclosed<br>motor which draws the telescope apart. The electro-magnetic field sent from the<br>Transmitter to the Receiver is converted in the Receiver into DC-Voltage to supply<br>the motor of the subject Fitbone Trochanteric Nails with voltage, when actioned.<br>The subject Fitbone Trochanteric Nails are available in two different diameter<br>models (D09mm, D11mm), different lengths and lengthening capabilities.<br>The subject nail is anchored to the bone by subject locking screws. The locking | | | screws are available in two variants (standard locking screws and revision locking<br>screws), in two diameters, D4.5mm and D4mm, and in multiple lengths.<br>The energy needed for the distraction process is transmitted from the outside by<br>placing the external transmitter over the implanted receiver, which is placed in the<br>subcutaneous tissue during surgery. | | | There is no transcutaneous contact between the implanted intramedullary nail and<br>the outer surface of the patient's body. | | | The subject trial nails accessories are available for each variant of the Fitbone<br>Trochanteric nails and are used to simulate the shape of the implant.<br>The subject Fitbone Trochanteric nail and K-wire are provided in sterile conditions<br>only. The trial nails are provided in non-sterile version only. The bone screws are<br>available in both sterile and non-sterile versions. | | | The subject Fitbone Trochanteric Nails and their accessories are made from, as<br>follows:<br>Nail: implant grade stainless steel 1.4441, according to ASTM F138-13<br>"Standard Specification for Wrought 18Chromium-14Nickel-<br>2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS<br>S31673)", and Silicone Nusilmed (NuSil MED-4870, NuSil MED-1511,<br>Nusil MED 4750, NUSIL MED1-161, NUSIL MED2-4502). Trial nail: implant grade stainless steel 1.4441, according to ASTM F138-<br>13 "Standard Specification for Wrought 18Chromium-14Nickel-<br>2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS<br>S31673)" and ASTM F899-20 Standard Specification for Wrought<br>Stainless Steels for Surgical Instruments. Locking screws: implant grade stainless steel 1.4441, according to ASTM<br>F138-13 "Standard Specification for Wrought 18Chromium-14Nickel-<br>2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS<br>S31673)" K-wire: implant grade stainless steel 1.4441, according to ASTM F138-13<br>"Standard Specification for Wrought 18Chromium-14Nickel-<br>2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS<br>S31673)" | | | The Subject, as the primary predicate, will be implanted only by Healthcare<br>Professionals (HCP), with full awareness of the appropriate orthopedic procedures | {5}------------------------------------------------ Image /page/5/Picture/2 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, sans-serif font. A small registration mark is present to the right of the "X" in "ORTHOFIX". | Indications for use | | FITBONE® Trochanteric is indicated for limb lengthening of the femur.<br>FITBONE® Trochanteric is indicated for adult and pediatric (greater than 12 through<br>21 years of age) patients. | | |----------------------------------|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | Technological<br>Characteristics | | The following table provides a comparison of technological characteristic of the<br>subject and primary predicate device.<br>Any differences have been demonstrated not to raise different questions of safety<br>and effectiveness. | | | | Technological<br>Characteristic | Subject Device<br>(Fitbone Trochanteric) | Predicate Device<br>(Fitbone TAA, K203399) | | 1. | Intended use and<br>indications for<br>Use | Fitbone™ Trochanteric is indicated for<br>limb lengthening of the femur.<br>Fitbone Trochanteric is indicated for<br>adult and pediatric (greater than 12<br>through 21 years of age) patients.<br>Assessment: The Subject device is indicated for limb lengthening of the femur.<br>This anatomical site is a subset of the indications of the primary predicate. | Intended for limb lengthening of the<br>femur and tibia.<br>Indicated for adult and pediatric<br>(greater than 12 through 21 years of<br>age) patients<br> | | 2. | Anatomical Sites | Femur | Femur, tibia | | | | Assessment: The anatomical sites for use are a subset of primary predicate. | | | 3. | Intended<br>environment | Clinic or Home environment | Clinic or Home environment | | | | Assessment: The intended environment is the same as the primary predicate. | | | 4. | Nail Material | Implant Grade Stainless Steel (1.4441,<br>316LVM) | Implant Grade Stainless Steel<br>(1.4441, 316LVM) | | | | Assessment: Subject material identical to primary predicate. | | | 5. | Nail Size Range | 225-365mm in length; 11 and 13mm<br>diameters in varying configurations | 200-245mm in length; 9, 11, and<br>13mm diameters in varying<br>configurations | | | | Assessment: Diameter size ranges are similar to primary predicate.<br>Potential performance differences arising from variations in size offerings was<br>analyzed through bench testing, performed on subject and predicate device<br>Further mitigation is provided through weight bearing precautions in labeling. | | | 6. | Maximum<br>distraction<br>possible | From 40mm (with nail length 225mm)<br>to 80mm (with longer nails) | From 40mm (with nail length 200mm)<br>to 80mm (with longer nails)) | | | | Assessment: The maximum distraction possible of the Subject device is<br>equivalent to the primary predicate. The worst case scenario (maximum<br>distraction possible of 80 mm) is identical to the primary predicate device. | | | 7. | Method of<br>Distraction/Energy<br>Source | Internal motor electro-magnetically<br>induced by an external transmitter with<br>signal received through a receiver<br>placed just under skin | Internal motor electro-magnetically<br>induced by an external transmitter<br>with signal received through a<br>receiver placed just under skin | | | | Assessment: Subject distraction methodology is identical to primary predicate. | | | 8. | Sterilization<br>Method | Gas Plasma<br>Gas Plasma<br>Assessment: The sterilization method is identical to the primary predicate. | | | | Performance<br>Analysis | Subject devices have similar configuration, material, sizes, and design to the primary<br>predicate FITBONE® TAA (K203399) and the additional reference devices. The<br>following mechanical testing was performed:<br>Implantable nails and screws:<br>Static and fatigue 4-point bending test for subject Fitbone Trochanteric nails performed according to ASTM F1264-16 - "Standard Specification and Test Methods for Intramedullary Fixation Devices", 4-point bending test for subject locking screws per ASTM F1264-16 - "Standard Specification and Test Methods for Intramedullary Fixation Devices", Axial Load and vibration tests of subject Fitbone Trochanteric nails per custom test protocol, Testing of subject Fitbone Trochanteric nails per ISO 14708-1:2014 - "Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer", Torsional strength, insertion/removal torque, self-tapping properties, and pull out test performed according to ASTM F543-17. | | | Conclusion | | Based upon equivalences in: intended use, patient population, site of application,<br>conditions of use, operating principles, and the non-clinical performance data, the<br>subject FITBONE® Trochanteric nail have been shown to be safe and effective and<br>to perform equivalently as compared to the legally marketed predicate device<br>(K203399). | | {6}------------------------------------------------ Image /page/6/Picture/2 description: The image shows the word "ORTHOFIX" in black font. To the left of the word is a blue symbol that looks like three curved shapes stacked on top of each other. The symbol is a stylized version of the letter O. There is a registered trademark symbol to the right of the word.