GYDER® Hip System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other. January 29, 2025 Gyder Surgical Pty Ltd. % David Rutledge Consultant Global Strategic Solutions, LLC 1631 Mercy Street Mountain View, California 94041 Re: K243387 Trade/Device Name: GYDER® Hip System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: October 26, 2024 Received: October 31, 2024 Dear David Rutledge: 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" {1}------------------------------------------------ (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). 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 OS 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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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 {2}------------------------------------------------ by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Shumaya Ali -S Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K243387 Device Name GYDER® Hip System # Indications for Use (Describe) Indications For Use The GYDER® Hip Navigation System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during stereotactic orthopaedic surgical procedures. The GYDER® Hip Navigation System facilitates the accurate positioning of the acetabular cup only during Anterior Hip Arthroplasty approaches with the patients in supine position. | 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." {4}------------------------------------------------ ## K243387 510(k) Summary # Applicant Information: Gyder Surgical Pty Ltd 30 – 32 Compark Circuit, Mulgrave, Victoria, 3170, Australia Contact Person: Sujit Dike Title: Chief Executive Officer Phone: +1 484-886-7331 Email: sujit@gydersurgical.com Primary Correspondent, Authorized Consultant and 510(k) Submitter: David R. Rutledge Global Strategic Solutions, LLC 1631 Mercy Street, Mountain View, CA 94041, United States Phone: +1 630-846-0350 Email: David.Rutledge@GlobalStrategicSolutions.com Device Name: GYDER® Hip System Common Name: Stereotaxic Instrument Regulation name: Orthopedic Stereotaxic Instrument Classification: Class II Product Code: OLO Submission Type: Traditional 510(k), New Device Regulation Number: 21 CFR 882.4560 Predicate Device: OrthAlign Plus System (K130387) #### Indications For Use The GYDER® Hip Navigation System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during stereotactic orthopaedic surgical procedures. The GYDER® Hip Navigation System facilitates the accurate positioning of the acetabular cup only during Anterior Hip Arthroplasty approaches with the patients in supine position. #### Intended Use The GYDER® Hip Navigation System is intended to be used only during Anterior Hip Arthroplasty approaches with the patients in supine position, with acetabular cups that are uncemented and allow for post-impaction measurement and confirmatory measurement. {5}------------------------------------------------ ## Device Description The GYDER® Hip System is a computer controlled non-invasive surgical tool to aid navigation during Total Hip Arthroplasty via the Anterior Approach. The system includes both reusable and consumable components, designed to work together to assist the surgeon in positioning the acetabular cup in the intended orientation during primary or revision Total Hip Arthroplasty. ## Substantial Equivalence The GYDER® Hip Navigation System is substantially equivalent to the OrthAlign Plus System predicate device in the Hipalign configuration based on the analysis of Clinical, and Biological characteristics and performance data that includes bench and cadaver based tests. ## Comparison between GYDER® Hip System and the Predicate Device | Attribute | Subject Device:<br>GYDER® Hip Navigation System | Predicate Device<br>OrthAlign Plus® in the HipAlign®<br>configuration | Comparison<br>Differences<br>/Similarities | |---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------| | | | | | | 510(k) Number | New application | K130387 [3]<br>Orthalign Plus® in the HipAlign®<br>configuration for Total Hip<br>Arthroplasty (THA). | N/A | | FDA Regulation | 882.4560 | 882.4560 | EQUIVALENT. | | Product Code | OLO: Orthopedic Stereotaxic Instrument | OLO: Orthopedic Stereotaxic<br>Instrument | EQUIVALENT. | | Product Classification | Class II | Class II | EQUIVALENT. | | Use | Prescription Use/ Rx Only | Prescription Use/ Rx Only | EQUIVALENT. | | Intended User | Primary user: Orthopedic Surgeon<br>Secondary user: Surgical Assistant / Nurse | Primary user: Orthopedic Surgeon<br>Secondary user: Surgical Assistant /<br>Nurse | EQUIVALENT. | | Use Environment | Hospital / Operating Theatre | Hospital / Operating Theatre | EQUIVALENT | | Patient Population | Patients undergoing Total Hip<br>Arthroplasty:<br>• Anterior Approach with patient supine. | Patients undergoing Total Hip<br>Arthroplasty.<br>• Anterior Approach with patient<br>supine<br>• Posterior Approach with patient<br>lateral decubitus. | EQUIVALENT for<br>Anterior<br>Approach.<br>GYDER® Hip<br>Navigation<br>System does not<br>support Posterior<br>Approach. | | Attribute | Subject Device:<br>GYDER® Hip Navigation System | Predicate Device<br>OrthAlign Plus® in the HipAlign®<br>configuration | Comparison<br>Differences<br>/Similarities | | Indications for Use | The GYDER® Hip Navigation System is a<br>computer-controlled system intended to<br>assist the surgeon in determining<br>reference alignment axes in relation to<br>anatomical structures during stereotactic<br>orthopedic surgical procedures. The<br>GYDER® Hip Navigation System facilitates<br>the accurate positioning of the acetabular<br>cup relative to the alignment axes.<br>Example orthopedic surgical procedures<br>include:<br>• Total Hip Arthroplasty: Anterior<br>The GYDER® Hip Navigation System for<br>supine patient registration is indicated for<br>use:<br>• In Hip Arthroplasty surgical procedures;<br>• with acetabular cups that are<br>uncemented and allow for post-<br>impaction measurement and<br>confirmatory measurement. | The HipAlign® System is a<br>computer-controlled system<br>intended to assist the surgeon in<br>determining reference alignment<br>axes in relation to anatomical and<br>instrumentation structures during<br>stereotactic orthopedic surgical<br>procedures. The HipAlign® System<br>facilitates the accurate positioning<br>of implants, relative to the<br>alignment axes.<br>Example orthopedic surgical<br>procedures include but are not<br>limited to:<br>• Total Hip Arthroplasty:<br>Anterior/Posterior | EQUIVALENT for<br>Anterior<br>Approach.<br>GYDER® Hip<br>Navigation<br>System does not<br>support Posterior<br>Approach. | | Operating Conditions | Specified storage and operating<br>conditions for surgical environments<br>• Hospital use, normal ambient<br>conditions of temperature, and lighting<br>• Within the sterile field of an operating<br>theatre<br>• Temperature: 16 to 24°C<br>• Humidity: 20 to 60% RH (non-<br>condensing)<br>• Pressure: 70 kPa to 106 kPa | Specified storage and operating<br>conditions for surgical<br>environments<br>• Hospital use, normal ambient<br>conditions of temperature, and<br>lighting<br>• Within the sterile field of an<br>operating theatre<br>• Temperature: 15 to 25°C<br>• Humidity: 10 to 70% RH (non-<br>condensing)<br>• Pressure: 70 kPa to 106 kPa | EQUIVALENT | | Storage and<br>Transportation<br>Conditions | Specified storage conditions for typical<br>transport environments:<br>• Temperature: -30 to 60°C<br>• Humidity: 15 to 90% RH (non-<br>condensing)<br>• Pressure: 50 kPa to 106 kPa | Specified storage conditions for<br>typical transport environments:<br>• Temperature: -30 to 60°C<br>• Humidity: 10 to 95% RH (non-<br>condensing)<br>• Pressure: 60 kPa to 101 kPa | EQUIVALENT | | System<br>Characteristics | Computer-assisted navigation system | Computer-assisted navigation<br>system | EQUIVALENT | | Control Mechanism | Electronics attached to movable<br>instruments, placed in specific procedural<br>positions, on or in contact with bony<br>anatomy, for recording sensor data. | Electronics attached to movable<br>instruments, placed in specific<br>procedural positions, on or in<br>contact with bony anatomy, for<br>recording sensor data. | EQUIVALENT | | Attribute | Subject Device:<br>GYDER® Hip Navigation System | Predicate Device<br>OrthAlign Plus® in the HipAlign®<br>configuration | Comparison<br>Differences<br>/Similarities | | | | | | | Operating<br>Principle/Registration<br>of Anatomy | Patient registration referencing Anterior<br>Pelvic Plane landmarks using a non-<br>invasive mechanical device. Sensors are<br>attached to moveable instruments placed<br>in specified procedural positions, on or in<br>contact with bony anatomy, for recording<br>data. Measurements to confirm the final<br>implant angles after implantation has<br>been completed. | Patient registration referencing<br>Anterior Pelvic Plane landmarks<br>using invasive pins. Sensors are<br>attached to moveable instruments<br>placed in specified procedural<br>positions, on or in contact with<br>bony anatomy, for recording data.<br>Measurements to confirm the final<br>implant angles after implantation<br>has been completed. | SIMILAR | | Measurement and<br>Navigation | • Computer derived values.<br>• Inertial Measurement Unit (IMU<br>containing Accelerometer and rate<br>gyroscope) measurement of<br>orientation of instrument. | • Computer derived values.<br>• Inertial Measurement Unit (IMU<br>containing Accelerometer and<br>rate gyroscope) measurement of<br>orientation of instrument. | EQUIVALENT | | Main Components | Sensors and Software:<br>• Navigation Unit (reusable computer)<br>• Navigation and measurement software<br>Single-Use items:<br>• Clam Shell (navigation unit sterile<br>enclosure)<br>• ASIS Markers<br>• APP Ruler<br>Re-usable Instrument sets:<br>• Orthopaedic Brace and Impactor Set<br>• Impactor (as manufactured by Mac<br>Surgical) | Sensors and Software:<br>• Navigation Unit (reusable<br>computer unit)<br>• Navigation and measurement<br>software<br>Single -Use items<br>• Single-use sensor<br>Re-usable Instrument sets:<br>• Pelvic Pins and instrument set<br>• Impactor | EQUIVALENT. | | User interface | Integrated Graphical User Interface. The<br>device uses algorithms to convert sensor<br>outputs into spatial coordinates,<br>providing graphical and numerical<br>representations of the instruments<br>relative to patient anatomy on the NU<br>screen. | Integrated Graphical User Interface.<br>The device utilizes algorithms to<br>convert sensor outputs into spatial<br>coordinates, providing graphical<br>and numerical representation of<br>instruments relative to patient<br>anatomy on the computer screen. | EQUIVALENT. | | Sterility (incl.<br>method) | • Navigation Unit protected by sterile<br>Clam Shell and is not exposed to<br>biological contaminants.<br>• Clam Shell and ASIS Markers: EO<br>sterilization.<br>• Orthopaedic Brace, Impactor Bracket,<br>Impactor: Steam/autoclave<br>sterilization. | • Navigation Unit: EO sterilization.<br>• Instruments: autoclave<br>sterilization | EQUIVALENT | | Energy Sources | • Navigation Unit:<br>• DC battery power<br>• Other components are passive | • Navigation unit and reference<br>sensor:<br>• DC battery power | EQUIVALENT. | | Attribute | Subject Device:<br>GYDER® Hip Navigation System | Predicate Device<br>OrthAlign Plus® in the HipAlign®<br>configuration | Comparison<br>Differences<br>/Similarities | | | | | | | | | • Other components are passive | | | Analytical Studies | • Cadaver study performed. | • Cadaver study performed. | EQUIVALENT. | Table 1. Comparison of Subject Device to Predicate Device {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ #### Performance Data Device performance testing confirms that the GYDER® Hip Navigation System can be used according to its intended use. The GYDER® Hip Navigation System has been verified and validated according to Gyder Surgical procedures for product design and development. Performance testing addressed the functionality and surgical procedure workflows/steps as defined in the GYDER® Hip System Instructions for Use and demonstrates that the GYDER® Hip System is as safe, as effective, and performs as well as the predicate device [OrthAlign Plus® System (K130387)]. #### Non-Clinical Testing Testing included: • Software verification and validation to ensure the integrity of the code and functionality and reliability of the software in various use sequences. - System hardware verification/validation testing to ensure the device meets their functional requirements. - Instrumentation cleaning, sterilization and shipping validations for the specified processes. - · System components biocompatibility assessment per ISO 10993-1 (2018). - System accuracy testing by bench testing for angle measurement accuracy including using ASTM F2554-18. - · System usability testing for formative and summative testing. - Simulated use testing in cadaver with advising surgeons to validate the system meets requirements for user needs and usability in a simulated use environment. This testing regime demonstrates that the subject device is as safe and performs as well as the predicate device. #### Clinical Testing No clinical trial required. Simulated use testing on cadavers performed #### Conclusion The GYDER® Hip System is substantially equivalent to the predicate device OrthAlign Plus® System (K130387). Testing against the FDA consensus performance standard (ASTM F2554-18) and clinical {9}------------------------------------------------ validation using cadaver models has demonstrated that the GYDER® Hip System is as safe and as effective as the predicate device.