Apex Femoral Nailing System

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July 17, 2018 OrthoXel % Hollace Rhodes Director, Orthopedic Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers LLC 1050 K Street NW Suite 1000 Washington, District of Columbia 20001 Re: K181375 Trade/Device Name: Apex Femoral Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB, JDS Dated: May 23, 2018 Received: May 24, 2018 Dear Ms. Rhodes: 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); {1}------------------------------------------------ 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 comprehensive regulatory information about medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K181375 ### Device Name Apex Femoral Nailing System ### Indications for Use (Describe) The Apex Femoral Nailing system is intended for temporary fixation of the fractures of the femur. The Apex nail is indicated for used in adult patients for treatment of: - · Open and closed fractures, including simple, severely comminuted, spiral, large oblique, and segmental fractures; - · Fractures involving osteopenic or osteoporotic bone; - · Fractures with bone loss; - · Pseudoarthosis, nonunion, and malunion; - · Correction osteotomy; - · Pathologic fractures and prophylactic nailing of impending pathologic fractures; - · Periprosthetic fractures; - · Closed supracondylar fractures (retrograde only) and: - · Intertrochanteric and subtrochanteric fractures (antegrade only) Type of Use (Select one or both, as applicable) ري Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ ## 510(k) Summary for Apex Femoral Nail System #### 1 Submission Sponsor OrthoXel, Rubicon Centre, Bishopstown, Cork, Ireland, T12 Y275 Phone: +353 21 2429700 Contact: Aisling O'Sullivan QA/RA Director Email: aisling.osullivan@orthoxel.ie #### 2 Prepared by Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street, NW, Suite 1000 Washington, DC 20001 Phone: 202.552.5800 Contact: Ms. Hollace Saas Rhodes Senior Director, Orthopedic Regulatory Affairs Email: hrhodes@mcra.com #### 3 Date Prepared July 6, 2018 #### 4 Device Name | 4.1 | Trade/Proprietary Name: | Apex Femoral Nailing System | |-----|----------------------------|-----------------------------| | 4.2 | Common/Usual Name: | Femoral Nail | | 4.3 | Classification Name: | Intramedullary Fixation Rod | | 4.4 | Classification Regulation: | 21 CFR 888.3020 | | 4.5 | Classification Panel: | Orthopedics | | 4.6 | Product Codes: | HSB, JDS | | 4.7 | Device Class: | II | {4}------------------------------------------------ #### 5 Predicate Devices The System is substantially equivalent to the Zimmer Natural Nail (K172114) based on similarities in intended use, technological characteristics, and performance data. #### ട Device Description The Apex Femoral Nailing system is a femoral intramedullary fixation system designed to be implanted and interlocked proximally and distally using bone screws or a provided surgical instrumentation kit. Like many of the currently-marketed intramedullary nails, the Apex Nail offers several different proximal and distal locking options from which the surgeon may choose, depending on the fracture. An insert within the proximal nail stem maintains the high torsional stability of static locking when the construct is locked in a dynamization mode. The Apex Femoral Nailing System include a femoral nail, bone screws, bolts and endcaps of varying sizes. All parts of the system are manufactured from Titanium 6AL4VELi. The Apex Femoral Nail, screw, bolt and endcap are available in varying lengths and diameters. #### 7 Intended Use The Apex Femoral Nailing system is intended for temporary fixation of the fractures of the femur. The Apex nail is indicated for used in adult patients for treatment of: - Open and closed fractures, including simple, severely comminuted, spiral, large oblique, and segmental fractures; - Fractures involving osteopenic or osteoporotic bone; - Fractures with bone loss; - Pseudoarthrosis, nonunion, and malunion; - Correction osteotomy; - Pathologic fractures and prophylactic nailing of impending pathologic fractures; - Periprosthetic fractures; - Closed supracondylar fractures (retrograde only) and: - Intertrochanteric and subtrochanteric fractures (antegrade only) #### 8 Technological Characteristics and Substantial Equivalence The Apex Femoral Nailing System is substantially equivalent to the Zimmer Natural Nail, with respect to intended use, technological characteristics (components, materials, overall design, and dimensions), sterility, and principles of operation. #### 9 Reference Devices The Apex Tibial Nailing System (K170972) and NovaLign Intramedulary Fixation System (K083458) are included as reference devices based on similarities in raw materials, manufacturing steps and reagents, technological characteristics, and performance data. {5}------------------------------------------------ ## 10 Non-Clinical Performance Testing The Apex Femoral Nailing System was tested in accordance with the following standards and all acceptance criteria were met: - ASTM F1264-16 Standard specification and test methods for intramedullary fixation devices. - ASTM F543-07 Standard specification and test methods for metallic medical bone screws. - Full Construct Testing - Bacterial Endotoxin Testing #### 11 Conclusion This 510(k) submission supports the substantial equivalence of the Apex Femoral Nailing System to the referenced predicate device.