Artemis Proximal Femoral Nail System

{0}------------------------------------------------ February 19, 2021 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo 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. GLW, Inc. % Nancy Lincé President & CEO Lincé Consulting, LLC 111 Deerwood Road, Suite 200 San Ramon, California 95483 Re: K201379 Trade/Device Name: Artemis Proximal Femoral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, HWC Dated: January 15, 2021 Received: January 19, 2021 Dear Nancy Lincé: 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. 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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 {1}------------------------------------------------ 542 of the Act); 21 CFR 1000-1050. 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 (QS) 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- 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 medical devices and radiation-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, For Michael Owens 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 510(k) Number (if known) K201379 Device Name Artemis Proximal Femoral Nail System Indications for Use (Describe) The Artemis Proximal Femoral Nail System is indicated for fixation of stable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections. 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. 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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}------------------------------------------------ ## 510K SUMMARY | Date Prepared | January 15, 2021 | |--------------------------|----------------------------------------------------------------------------------------------------------------------------| | Submitter | GLW, Inc.<br>300 Sylvan Avenue<br>Englewood Cliff, NJ 07632<br>USA | | Submitter Contact | Arundhati Radhakrishnan<br>Quality Assurance Manager<br>Phone: (201) 268-3281<br>Email: arundhati.radhakrishnan@glwmed.com | | Correspondent<br>Contact | Nancy Lincé<br>Lincé Consulting, LLC<br>President & CEO<br>Phone: (650) 759-6186<br>Email: nlince@linceconsulting.com | | Device Name | Artemis Proximal Femoral Nail System | | Common Name | Rod, fixation, intramedullary and accessories<br>Screw, fixation, bone | | Class | Class II | | Product Code | HSB<br>HWC | | Classification | 21 CFR 888.3020: Intramedullary fixation rod<br>21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener | | Device Panel | Orthopedic | | Primary Predicate | K043431 Gamma3 Trochanteric Nail | | Reference Predicate | K173652 Piccolo Composite Nailing System | {4}------------------------------------------------ | Device Description | The Artemis Proximal Femoral Nail System is an intramedullary fracture fixation<br>system intended for temporary stabilization of bone segments or fragments in the<br>proximal femur. The system includes single-use, sterile implants (Proximal<br>Femoral Nail Kit Short, Locking Screw, and Lag Screw) as well as non-sterile,<br>reusable, Class I and II surgical instruments. The nail and screws are made of<br>titanium alloy Ti-6Al-4V. The titanium alloy nail is partially over-molded with<br>carbon fiber reinforced polymer (CFR PEEK).<br><br>The Artemis Nail is a cylindrical rod with a preassembled 4mm Set Screw,<br>available in one size with a distal diameter of 11mm, a proximal diameter of<br>16.4mm, and a length of 180mm. The Nail is designed with holes, at the proximal<br>and distal sections, for the insertion of a Lag Screw and Locking Screw,<br>respectively. The Lag Screw has a diameter of 11mm and is available in various<br>lengths ranging from 70mm to 130mm. The Locking Screw has a diameter of 5mm<br>and is available in various lengths ranging from 25mm to 110mm. | |----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The Artemis Proximal Femoral Nail System is indicated for fixation of stable<br>and unstable intertrochanteric fractures, including but not limited to nonunion,<br>malunion and tumor resections. | | Performance Data | The Artemis Proximal Femoral Nail System successfully underwent mechanical<br>testing in accordance with ISO 7206-4, ASTM F1264, and ASTM F543.<br>Performance characteristics for the Artemis Proximal Femoral Nail System<br>components included static and dynamic bending of construct, and screw torque to<br>failure and are comparable to those of predicate devices, thus demonstrating that<br>the device is substantial equivalent to the predicate. | | Clinical Performance Data | Clinical data was not needed for this device. | | Substantial<br>Equivalence | Device comparisons demonstrate that the Artemis Proximal Femoral Nail System<br>is substantially equivalent to the predicate device in terms of intended use,<br>indications for use, technological characteristics and operating principles. The<br>primary difference between the predicate and subject devices is the nail material;<br>the predicate device is constructed from titanium alloy and the subject device is<br>constructed from titanium alloy and partially over-molded CFR PEEK. The<br>reference device is included to address the material difference. | | Conclusion | The information included in the 510(k), which included comparison testing to the<br>predicate, demonstrates that any minor differences between the subject and<br>predicate devices do not raise new issues of safety or effectiveness when the device<br>is used as intended. |