X-Guide Surgical Navigation System

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION August 28, 2026 X-Nav Technologies, LLC Kimberly Chan Vice President of Regulatory Affairs and Quality Assurance 1555 Bustard Rd. Suite 75 & 110 Lansdale, Pennsylvania 19446 Re: K253954 Trade/Device Name: X-Guide Surgical Navigation System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: QRY, PLV Dated: August 10, 2026 Received: August 10, 2026 Dear Kimberly Chan: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K253954 - Kimberly Chan Page 2 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). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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 Rule"). 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-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K253954 - Kimberly Chan Page 3 assistance/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, # MICHAEL E. ADJODHA -S Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253954 | ? | | Please provide the device trade name(s). | | ? | | X-Guide Surgical Navigation System | | | | Please provide your Indications for Use below. | | ? | | The X-Guide® Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures and/or endodontic access procedures.The system provides software to preoperatively plan dental implantation procedures and/or endodontics access procedures and provides navigational guidance of the surgical instruments.The device is intended for use for partially edentulous and edentulous adult and geriatric patients who need dental implants as a part of their treatment plan. The device is also intended for endodontic access procedures (i.e., apicoectomies and/or access of calcified canals) where a CBCT is deemed appropriate as part of their treatment plan. | | | | Please select the types of uses (select one or both, as applicable). | Prescription Use (21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} X-NAV TECHNOLOGIES ## 510(k) Summary (As required by Section 807.92(c)) | Date Prepared: | 28 AUGUST 2026 | | --- | --- | | Applicant: | X-Nav Technologies, LLC 1555 Bustard Road, Suite 75 & 110 Lansdale, PA. 19446 | | Contact Person: | Kimberly Chan Vice President of Regulatory Affairs and Quality Assurance Phone: 267-436-0414 regulatory@x-navtech.com | | Device Trade / Proprietary Name: | X-Guide® Surgical Navigation System | | Device Name, Common/Usual: | Surgical Navigation System | | Classification Name: | 21 CFR 872.4120 (Bone Cutting Instrument and Accessories) | | Regulatory Class: | II | | Product Code: | QRY, PLV | | Predicate Device: | X-Guide® Surgical Navigation System (K232148) | | Reference Devices: | X-Guide® Surgical Navigation System (K150222, K200662, K192579, K211071) | 1555 Bustard Road, Suite #75, Lansdale, PA 19446 / 267-436-0420 / www.X-NavTech.com {5}  ## Device Overview The X-Guide Surgical Navigation System is a cart mounted mobile system utilizing video technology to track position and movement of a surgical instrument (Dental Handpiece) during surgical procedures. The system is designed to assist in navigation of dental surgeries utilizing a Dental handpiece. These surgeries include performing endodontic access procedures, and delivering regulatory cleared dental implants. The addition of ToolTrace and Straight Cuts further supports dental implantation procedures by allowing the navigation of bone reduction (alveoloplasty). This device consists of a Mobile Cart, equipped with a Monitor, Boom Arm, Navigation Assembly, optional Keyboard, Mouse and an Electronics Enclosure. The Electronics Enclosure contains system power supplies, data processing hardware, and electronics control circuitry for coordinating operation of the X-Guide Surgical Navigation System. A Monitor, Keyboard, and Mouse serve as the main user interface for the surgeon. The Boom Arm allows the operator to manipulate the Navigation Assembly position for optimal distance and alignment to patterns located with the surgical region (Surgi-Zone) for tracking purposes. The Navigation Assembly contains two cameras oriented in a stereo configuration, along with blue lighting for illuminating the patterns and mitigating ambient lighting noise. This electro-optical device is designed to aid in dental surgical procedures by providing the surgeon with accurate surgical tool placement and guidance with respect to a surgical plan built upon Computed Tomographic (CT scan) data. The surgical process occurs in two stages. Stage 1 is the pre-operative planning of the surgical procedure. The dental surgeon plans the surgical procedure in the X-Guide System Planning Software. A virtual implant or trajectory is aligned and oriented to the desired location in the CT scan, allowing the dental surgeon to avoid interfering with critical anatomical structures during surgery. Once an implant or trajectory has been optimally positioned, the plan is transferred to the X-Guide Surgical Navigation System in preparation for surgery. In Stage 2, the intra-operative surgical stage, the system provides accurate guidance of the dental surgical instruments according to the pre-operative plan. Two primary, case-specific calibrations underpin the guidance system: Patient Tracker calibration and Handpiece calibration. Patient Tracker calibration is performed to determine the geometric relationship between the Patient Tracker and patient anatomy. Handpiece calibration is performed to determine the geometric relationship between the Handpiece Tracker or ToolTrace Handpiece Tracker and the tip of the surgical instrument. After calibration, as the dental surgeon moves the surgical instrument around the patient anatomy, 2D barcode tracking patterns on the Handpiece Tracker, ToolTrace Tracker, and the Patient Tracker are detected by visible light cameras in a stereo 1555 Bustard Road, Suite #75, Lansdale, PA 19446 / 267-436-0420 / www.X-NavTech.com {6} X-NAV TECHNOLOGIES configuration and processed by data processing hardware to precisely and continuously track the motion of the dental handpiece and the surgically-relevant portion of the patient. The relative motion of the dental handpiece and the patient anatomy, captured by the tracking hardware, is combined with patient-specific calibration data. This enables a 3D graphical representation of the handpiece to be animated and depicted in precise location and orientation relative to a 3D depiction of the target, along with depictions of the patient anatomy, and other features defined in the surgical plan. This provides continuous visual feedback that enables the dental surgeon to maneuver the dental handpiece into precise alignment. During execution of the surgical procedure, the X-Guide® Surgical Navigation System correlates between the surgical plan and the surgeon's actual performance. If significant deviations in navigation between the plan and the system performance occur, the system will alert the user. Device accuracy has been evaluated for compliance with FDA recognized performance standard ASTM F2554- 18, Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems. Figure 1: X-Guide® Surgical Navigation System (P007839)  Figure 2: X-Guide® Surgical Navigation System (P011000)  1555 Bustard Road, Suite #75, Lansdale, PA 19446 267-436-0420 www.X-NavTech.com {7} X-NAV TECHNOLOGIES # Device Description The system provides the surgeon with a three-dimensional real time video visual aid to indicate dental drill location in space, with 6 degrees of freedom (X, Y, Z, Pitch, Yaw, and Roll) and an accuracy (RMS) of < 1 mm. This aids in the surgeon drilling precision within a patient oral cavity. Since the system is video based, the surgeon is still working in the freehand mode, meaning he/she is always in control of the surgery. Several patient-specific calibrations underpin the guidance system. Hand Piece calibration is performed to determine the geometric relationship between the Hand Piece Tracker and the tip of the surgical instrument. 1555 Bustard Road, Suite #75, Lansdale, PA 19446 267-436-0420 www.X-NavTech.com {8} X-NAV TECHNOLOGIES ## Straight Cuts and ToolTrace The proposed change is a software change with associated physical component changes, described below: - Straight Cuts Planning and Navigation - ToolTrace Calibration and Visualization during Navigation ### Straight Cuts Planning Straight Cuts Planning allows the use of a new planning tool during planning. Straight Cuts Planning can be used to specify a straight cut between two defined points at a specific angle and depth. The planning screen allows for the practitioner to plan quadrilateral-shaped planning elements with a defined thickness. Multiple straight cuts can be added in sequential fashion using the Extend button. These defined lines can be used to define cuts during surgery for bone reduction (alveoloplasty) using a cutting instrument. The end user creates the plan using 'control rods' which define the endpoints of the cut. The endpoints are agnostic to which is the 'start' and which is the 'end.' Similarly to how single-trajectory points are currently defined in the X-Guide System, the Straight Cuts plan dimensions are controlled in the RxPanel, and affect the selected quadrilateral. ### Straight Cuts Navigation Straight Cuts Navigation allows the use of an alternative cutting guidance during navigated surgery. The trajectory visualization includes depth, position, and a cutting path to a user-defined endpoint. The visualization for this feature is similar to that of the existing single-trajectory user interface during navigation. The interface shows pitch, roll, yaw, x, y, z, and depth of the handpiece relative to the planned quadrilateral. - The depiction of pitch, roll, and yaw are identical between the single-trajectory interface and the Straight Cuts interface. - Depth is depicted as a fillable bar which stretches across the entire path from Control Rod to Control Rod. The depth is a function of the location along the path. - X, Y, and Z are still shown as the handpiece representation moving across the screen. Unlike single-trajectory navigation, the user is intended to follow the path from one Control Rod to the second Control Rod. ### ToolTrace Calibration ToolTrace is a new calibration method that can be used on cutting instruments with a variety of tip geometries (e.g., piezoelectric tips). The calibration involves identifying the tip location, cutting plane, and overall shape. These tool features are then displayed during navigated surgery to help the doctor align with the plan. 1555 Bustard Road, Suite #75, Lansdale, PA 19446 / 267-436-0420 / www.X-NavTech.com {9} NAV TECHNOLOGIES The process used to attach the Handpiece to the Handpiece Tracker is identical to the existing process for single-point burr ended handpieces. There are three components to calibration that must be performed: Tip Trace, Cutting Edge Trace, and Shape Trace. ## ToolTrace Visualization during Navigation An instrument calibrated using ToolTrace can be used in either a single-trajectory navigation, or in a Straight Cut navigation. The visualization appears differently compared to a shape-calibrated object, because the shape representation is customized to the user's specific tool. 1555 Bustard Road, Suite #75, Lansdale, PA 19446 / 267-436-0420 / www.X-NavTech.com {10}  ## Additional EDX Bone Screw Dimensions To allow for tracking, physical components are sold with the X-Guide System, including Bone Screws. The Bone Screw is intended to be a transient, single use surgically invasive device. The Bone Screws are used to secure apparatus to the patient for mounting a tracking pattern, necessary for tracking patient positioning in space during surgical navigation. The Bone Screws are intended for use in adult and geriatric patient populations. The EDX Bone Screws are a titanium alloy self-drilling screws which are tapered and vary in diameters. The already released EDX Bone Screws have diameters of 2.7 mm and 3.2 mm with thread lengths of 7mm and stud lengths of 4 mm, 8 mm, and 16 mm. The smaller diameter EDX Bone Screws are typically placed to secure the EDX Tracker Arm. Should the bone be too soft resulting in a loose Bone Screw, a large diameter “rescue” EDX Bone Screw can be placed. All of the EDX Bone Screws and Caps are manufactured using a Ti6AL4V (Grade 5) alloy per ASTM F136 and adhere to the requirements of ASTM F543. There are no changes to this material. The Bone Screws are intended to be removed from the patient at the conclusion of the surgical procedure. The Bone Screws are single use devices, sold in a non-sterile state and intended to be sterilized by the end user prior to use. ## Proposed EDX Bone Screws | Individual Bone Screw Part Number | Individual Bone Screw Description | Packaged Part Number | Packaged Part Description | | --- | --- | --- | --- | | P011265 | Bone Screw, EDX, 2.7 mm Dia X 5 mm Thread, 4 mm Stud | P012325 | Bone Screw and Screw Cap, EDX - 2.7 Ø X 5 mm Thread, 4 mm Stud - 2ct | | P011266 | Bone Screw, EDX, 2.7 mm Dia X 5 mm Thread, 8 mm Stud | P012326 | Bone Screw and Screw Cap, EDX - 2.7 Ø X 5 mm Thread, 8 mm Stud - 2ct | | P011268 | Bone Screw, EDX, 3.2 mm Dia X 5 mm Thread, 4 mm Stud | P012327 | Bone Screw and Screw Cap, EDX - 3.2 Ø X 5 mm Thread, 4 mm Stud - 2ct | | P011269 | Bone Screw, EDX, 3.2 mm Dia X 5 mm Thread, 8 mm Stud | P012328 | Bone Screw and Screw Cap, EDX - 3.2 Ø X 5 mm Thread, 8 mm Stud - 2ct | | P011271 | Bone Screw, EDX, 2.0 mm Dia X 7 mm Thread, 4 mm Stud | P012329 | Bone Screw and Screw Cap, EDX - 2.0 Ø X 7 mm Thread, 4 mm Stud - 2ct | | P011272 | Bone Screw, EDX, 2.0 mm Dia X 7 mm Thread, 8 mm Stud | P012330 | Bone Screw and Screw Cap, EDX - 2.0 Ø X 7 mm Thread, 8 mm Stud - 2ct | | P011693 | Bone Screw, EDX, 2.0 mm Dia X 11 mm Thread, 4 mm Stud | P012331 | Bone Screw and Screw Cap, EDX - 2.0 Ø X 11 mm Thread, 4 mm Stud - 2ct | | P011694 | Bone Screw, EDX, 2.0 mm Dia X 11 mm Thread, 8 mm Stud | P012332 | Bone Screw and Screw Cap, EDX - 2.0 Ø X 11 mm Thread, 8 mm Stud - 2ct | | P011696 | Bone Screw, EDX, 2.0 mm Dia X 15 mm Thread, 4 mm Stud | P012333 | Bone Screw and Screw Cap, EDX - 2.0 Ø X 15 mm Thread, 4 mm Stud - 2ct | | P011697 | Bone Screw, EDX, 2.0 mm Dia X 15 mm Thread, 8 mm Stud | P012334 | Bone Screw and Screw Cap, EDX - 2.0 Ø X 15 mm Thread, 8 mm Stud - 2ct | | P012126 | Bone Screw, EDX, 2.7 mm Dia X 11 mm Thread, 4 mm Stud | P012335 | Bone Screw and Screw Cap, EDX - 2.7 Ø X 11 mm Thread, 4 mm Stud - 2ct | | P012127 | Bone Screw, EDX, 2.7 mm Dia X 11 mm Thread, 8 mm Stud | P012336 | Bone Screw and Screw Cap, EDX - 2.7 Ø X 11 mm Thread, 8 mm Stud - 2ct | | P012128 | Bone Screw, EDX, 2.7 mm Dia X 15 mm Thread, 4 mm Stud | P012337 | Bone Screw and Screw Cap, EDX - 2.7 Ø X 15 mm Thread, 4 mm Stud - 2ct | | P012129 | Bone Screw, EDX, 2.7 mm Dia X 15 mm Thread, 8 mm Stud | P012338 | Bone Screw and Screw Cap, EDX - 2.7 Ø X 15 mm Thread, 8 mm Stud - 2ct | 1555 Bustard Road, Suite #75, Lansdale, PA 19446 / 267-436-0420 / www.X-NavTech.com {11} X-NAV TECHNOLOGIES ## Proposed Labeling Changes – Removal of Contraindications X-Nav is removing the contraindications for zygoma implants and pterygoid implants based on literature showing that the use of X-Guide and similar navigation systems with optical tracking provide similar surgical support and drilling accuracy as conventional implants when used for placement of these longer implant types. 1555 Bustard Road, Suite #75, Lansdale, PA 19446 / 267-436-0420 / www.X-NavTech.com {12} X-NAV TECHNOLOGIES ## Indications for Use The X-Guide® Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures and/or endodontic access procedures. The system provides software to preoperatively plan dental implantation procedures and/or endodontics access procedures and provides navigational guidance of the surgical instruments. The device is intended for use for partially edentulous and edentulous adult and geriatric patients who need dental implants as a part of their treatment plan. The device is also intended for endodontic access procedures (i.e., apicoectomies and/or access of calcified canals) where a CBCT is deemed appropriate as part of their treatment plan. ## Intended Use The X-Guide® Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures and/or endodontic access procedures. The system provides software to preoperatively plan dental implantation procedures and/or endodontics access procedures and provides navigational guidance of the surgical instruments. 1555 Bustard Road, Suite #75, Lansdale, PA 19446 / 267-436-0420 / www.X-NavTech.com {13} NAV TECHNOLOGIES ## Specifications A comparison of the following specifications is itemized in the tables on the ensuing pages. - Use Specifications - Technology / Performance Characteristics - Safety Features - Components - Bone Screw Specifics ### Use Specifications | Use Spec | X-Guide® (Subject Device) | X-Guide® (Predicate Device) ; K232148 & K200662 | Navident (Predicate Device) ; K233563 & K210947 | Justification of Differences | | --- | --- | --- | --- | --- | | Indications for Use | The X-Guide® Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures and/or endodontic access procedures. The system provides software to preoperatively plan dental implantation procedures and/or endodontics access procedures and provides navigational guidance of the surgical instruments. The device is intended for use for partially edentulous and edentulous adult and geriatric patients who need dental implants as a part of their treatment plan. The device is also intended for endodontic access procedures (i.e., apicoectomies and/or access of calcified canals) where a CBCT is deemed appropriate as part of their treatment plan. | The X-Guide® Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures and/or endodontic access procedures. The system provides software to preoperatively plan dental implantation procedures and/or endodontics access procedures and provides navigational guidance of the surgical instruments. The device is intended for use for partially edentulous and edentulous adult and geriatric patients who need dental implants as a part of their treatment plan. The device is also intended for endodontic access procedures (i.e., apicoectomies and/or access of calcified canals) where a CBCT is deemed appropriate as part of their treatment plan. | Navident is a computerized dental navigational system intended to assist preoperative planning and to guide drilling in a patient jaw during implantation surgery and/or endodontic access procedures, using pre-acquired CT scan of the jaw. The device is intended for use by a qualified dental surgeon in the treatment of partially and fully edentulous jaws. The device is also intended for endodontic access procedures (i.e., access of calcified canals) where a CT scan is deemed appropriate as part of their treatment plan. | Differences in wording only. | | Use Environment | Clinical Setting, Doctors Office | Clinical Setting, Doctors Office | Dental Clinic | Differences in wording only. | | Contra-indications | - Not for use with patients less than 21 years of age. - Not for use with photosensitive epileptic patients. Patient sensitivity may be caused from the LEDs. | - Not for use with patients less than 21 years of age. - Not for use with photosensitive epileptic patients. Patient sensitivity may be caused from the LEDs. - Not for use with zygoma implants. - Not for use with pterygoid implants. | The use of Navident should be terminated when a stable coupling between the Navident optically-trackable marker and the patient's jaw cannot be achieved, or the accuracy check prior to the initiation of drill guidance has failed. | Removal of contraindications from Subject Device compared to Predicate X-Guide. Navident does not identify zygoma implants or pterygoid implants as contraindicated procedures. Subject of this 510(k). | 1555 Bustard Road, Suite #75, Lansdale, PA 19446 / 267-436-0420 / www.X-NavTech.com {14}  ## Technology/Performance Characteristics | Technology / Performance Characteristics | X-Guide® (Subject Device) | X-Guide® (Predicate Device); K232148 & K200662 | Navident (Predicate Device) ; K233563 & K210947 | Justification of Differences | | --- | --- | --- | --- | --- | | Tracking Technology | Stereo Cameras / LEDs / Pattern | Stereo Cameras / Pattern | Stereo Cameras / Checkerboard 'Tags' | No difference between Subject Device and Predicate X-Guide. Navident utilizes checkerboard 'tags' instead of patterns, but the tracking concept is the same. | | Calibration Frequency | Prior to each surgery | Prior to each surgery | Prior to each surgery | No difference. | | Overall System Accuracy (RMS) | <1mm | <1mm | ≤1.0mm | No difference. | | Software | Navigational Guidance and Trajectory Planning | Navigational Guidance and Trajectory Planning | Navigational Guidance and Trajectory Planning | No difference. | | Patient Calibration or Registration | X-Clip Edentulous Fiducials Anatomical Landmarks (X-Mark) | X-Clip Edentulous Fiducials Anatomical Landmarks (X-Mark) | NaviTray Edentulous Fiducials Anatomical Landmarks (Trace Register) | No difference between Subject Device and Predicate X-Guide. Navident has differences in wording only. | | Planning Screens | Implant and Trajectory Planning Straight Cuts Planning | Implant and Trajectory Planning | Implant and Trajectory Planning 'Saw Cut' Planning | Addition of Straight Cuts Planning to Subject Device compared to Predicate X-Guide. Navident utilizes 'Saw Cut' Planning to place a quadrilateral shape, in the same way ToolTrace would be used to place a quadrilateral shape. Subject of this 510(k) | | Handpiece Calibration | Contra-Angle Handpiece Calibration Straight Handpiece Calibration ToolTrace Calibration | Contra-Angle Handpiece Calibration Straight Handpiece Calibration | Contra-Angle Handpiece Calibration 'Saw Cut' Calibration with Piezoelectric Saw | Addition of ToolTrace Calibration method to Subject Device compared to Predicate X-Guide. Navident utilizes 'Saw Cut' Calibration to calibrate Piezo tools, in the same way ToolTrace would be used to calibrate Piezo tools. Subject of this 510(k) | | Navigation Types Supported | Single-Trajectory Navigation (Target View) Straight Cuts Navigation | Single-Trajectory Navigation (Target View) | Single-Trajectory Navigation (Target View) Drilling Along a Planned Cut | Addition of Straight Cuts Navigation to Subject Device compared to Predicate X-Guide. Navident utilizes planned rectangles for Saw Cuts, but the Navigation utilizes a Target View. Subject of this 510(k) | 1555 Bustard Road, Suite #75, Lansdale, PA 19446 / 267-436-0420 / www.X-NavTech.com {15} NAV TECHNOLOGIES ## Safety Features | Safety Features | X-Guide® (Subject Device) | X-Guide® (Predicate Device) ; K232148 & K200662 | Navident (Predicate Device) ; K233563 & K210947 | Justification of Differences | | --- | --- | --- | --- | --- | | Electrical Safety | IEC 60601-1:2005 Edition 3.2 AAMI ES60601-1:2005 +A1:2009 +A2:2010 EN 60601-1:2006 | IEC 60601-1:2005 Edition 3.2 AAMI ES60601-1:2005 +A1:2009 +A2:2010 EN 60601-1:2006 | IEC 60601- 1:2005 Edition 3.1 ANSI/AAMI ES60601-1:2005 / 2012 and C1:2009/ 2012 and A2:2010/ 2012 | No difference between Subject Device and Predicate X-Guide. Minor edition differences between X-Guide and Navident. | | Electromagnetic Compatibility | IEC 60601-1- 2:2014+AMD1:2020 | IEC 60601-1- 2:2014+AMD1:2020 | IEC 60601-1-2:2014 Edition 4.0. | No difference between Subject Device and Predicate X-Guide. Minor edition differences between X-Guide and Navident. | | Biocompatibility | ISO 10993-1, -5, -10, -11, -12 | ISO 10993-1, -5, -10, -11, -12 | ISO 10993-1 series | No difference | | Sterilization | Steam | Steam | Steam | No difference | | Disinfectant (High Level) | 3% Glutaraldehyde solution 0.55% Ortho-Phthalaldehyde (OPA) | 3% Glutaraldehyde solution | Metricide, Sporox, or Cidex | Addition of OPA as an acceptable high level disinfectant to Subject Device compared to Predicate X-Guide. Navident utilizes Cidex, which is an OPA solution. Not the subject of this 510(k), but was deemed not a significant change due to the use of the same assessment procedure. | | Ingress Protection | IP2X | IP2X | Not specified. | No difference | 1555 Bustard Road, Suite #75, Lansdale, PA 19446 / 267-436-0420 / www.X-NavTech.com {16}  ## Components | Components | X-Guide® (Subject Device) | X-Guide® (Predicate Device) ; K232148 & K200662 | Navident (Predicate Device) ; K233563 & K210947 | Justification of Differences | | --- | --- | --- | --- | --- | | Patient Tracking Device | X-Corner Patient Tracker | X-Corner Patient Tracker | Jaw Tacker Head Tracker | No difference between Subject Device and Predicate X-Guide. Navident Trackers have checkerboard patterns on them with a similar concept to the X-Guide X-Corner. | | Surgical Tool Tracking Device | X-Corner Handpiece Tracker X-Corner ToolTrace Handpiece Tracker | X-Corner Handpiece Tracker | Handpiece Tracker DrillTag | A second Handpiece Tracker with different patterns is added to the Subject Device so that the software can differentiate between a standard handpiece and a handpiece calibrated using ToolTrace. The tracking algorithm is identical between the two Handpiece Trackers, but uses a different 'expected' pattern for each. Subject of this 510(k). Navident also utilizes a checkerboard patterned Handpiece Tracker and DrillTag. | | Edentulous Patient Tracking Attachment System | Edentulous Clip EDX Tracker Arms CLX Tracker Arms Bone Screw(s) EDX Bone Screw(s), Additional Dimensions | Edentulous Clip EDX Tracker Arms CLX Tracker Arms Bone Screw(s) EDX Bone Screw(s) | Bone Fixation Screw Kits | Additional dimensions to the Bone Screws, subject of this 510(k). Navident recommends third party bone fixation screws. | | Patient Tracker Attachment Arms | Posterior Tracker Arm Anterior Tracker Arm | Posterior Tracker Arm Anterior Tracker Arm | Jaw Tracker T Jaw Tracker C Jaw Tracker B Jaw Tracker U Head Tracker | No difference between Subject Device and Predicate X-Guide. Navident Jaw Trackers allow for different configurations and orientations, similar to the X-Guide Tracker Arms | | Affixation to Handpiece | Handpiece Connector Nut Handpiece Adaptor ToolTrace Handpiece Adaptor | Handpiece Connector Nut Handpiece Adaptor | Tag Adapter | Addition of the ToolTrace Handpiece Adaptor is added to the Subject Device. This part uses the same principle to rigidly affix the Handpiece Tracker Pattern to the doctor's handpiece, but which must be slightly larger to accommodate the thicker handpiece. Navident utilizes a Tag Adaptor to connect the Handpiece Tracker and DrillTag to handpieces and piezo tools. | | Calibration Components | Calibration Disc Straight Calibration Bit ToolTrace Plate and Support Bar | Calibration Disc Straight Calibration Bit | Calibrator Tool | Addition of the ToolTrace Plate and Support Bar, which may be used to assist the doctor in the ToolTrace calibration process. Subject of this 510(k). Navident utilizes a Calibrator Tool which serves both as a Drill Bit Length Determination tool and an axis calibrator. | | Registration Tool | Probe Tool | Probe Tool | Tracer-3 / Tracer-4 | No difference | | Drill Bit Length Determination | Go Plate | Go Plate | Calibrator Tool | No difference | 1555 Bustard Road, Suite #75, Lansdale, PA 19446 / 267-436-0420 / www.X-NavTech.com {17}  ## Bone Screw Specifics | Components | X-Guide® (Subject Device) | X-Guide® (Predicate Device) ; K232148 & K200662 | Justification of Differences | | --- | --- | --- | --- | | Material | Titanium Ti-6AL-4V (Grade 5) | Titanium Ti-6AL-4V (Grade 5) | No difference | | Screw Type | Self-Drilling Self-Tapping | Self-Drilling Self-Tapping | No difference | | Manufacturing Method | Traditional (Subtractive) | Traditional (Subtractive) | No difference | | Sterilization | Shipped non-sterile Moist heat sterilization at end user site | Shipped non-sterile Moist heat sterilization at end user site | No difference | | Anatomical Sites | Mandible and Maxilla | Mandible and Maxilla | No difference | | Diameter | 2.0 mm (Classic and EDX) 2.7 mm (Classic and EDX) 3.2 mm (EDX only) | 2.0 mm (Classic screws only) 2.7 mm (Classic and EDX) 3.2 mm (EDX only) | Adds the 2.0 mm diameter thread option to EDX screws, subject of this 510(k) | | Thread Length | 4 mm (Classic only) 6 mm (Classic only) 8 mm (Classic only) 10 mm (Classic only) 5 mm (EDX only) 7 mm (EDX only) 11 mm (EDX only) 15 mm (EDX only) | 4 mm (Classic only) 6 mm (Classic only) 8 mm (Classic only) 10 mm (Classic only) 7 mm (EDX only) | Additional thread lengths for EDX screw type, subject of this 510(k) | | Stud Length | 4, 8, 16 mm | 4, 8, 16 mm | No difference | | Biocompatibility | Biocompatible in accordance with ISO 10993-1 | Biocompatible in accordance with ISO 10993-1 | No difference | | Single Use | Yes | Yes | No difference | | Shelf Life | None | None | No difference | | Surface Casting | Anodizing | Anodizing | No difference | 1555 Bustard Road, Suite #75, Lansdale, PA 19446 / 267-436-0420 / www.X-NavTech.com {18} NAV TECHNOLOGIES # Performance Testing No performance standards have been established for Dental Stereotaxic Instruments under Section 514 of the Food, Drug and Cosmetic Act. There are no changes to Biocompatibility, cleaning and sterilization, electrical safety, and electromagnetic compatibility. The components which were added to support ToolTrace are equivalent to the existing cleared X-Guide components, or could be justified. The bone screw components which are added are equivalent to the existing cleared X-Guide bone screws, and could be justified. Non-clinical testing supports the change to Indications for Use. For the removal of contraindications for zygomatic and pterygoid implants, published clinical and ex-vivo literature was used. ## Clinical Studies No clinical studies were performed for the submission of this 510k. ## Non-Clinical Assessment ### Verification and Validation Testing Verification and validation testing were conducted and documented. The combined testing and analysis of results provides assurance that the device performs as intended. | Verification/Validation Type | Description | | --- | --- | | Straight Cuts End User Validation | This validation test demonstrates that the software usability for Straight Cuts was deemed acceptable by real end users. | | ToolTrace End User Validation | This validation test demonstrates that the software usability for ToolTrace was deemed acceptable by real end users. | | Straight Cuts Cadaver Study Accuracy Validation Test Report | This validation test demonstrates that the Straight Cuts software is accurate compared to freehand on cadavers. | | ToolTrace Model Study Accuracy Validation | This validation test demonstrates that the ToolTrace software and hardware are accurate compared to freehand on models. | | Straight Cuts Software Verification | This verification test demonstrates that the X-Guide System software meets specifications and requirements. | | ToolTrace Software Verification | This verification test demonstrates that the X-Guide System software meets specifications and requirements. | 1555 Bustard Road, Suite #75, Lansdale, PA 19446 267-436-0420 www.X-NavTech.com {19} NAV TECHNOLOGIES ## Bench Testing Verification and validation testing were conducted and documented. The combined testing and analysis of results provides assurance that the device performs as intended. | Verification/Validation Type | Description | | --- | --- | | Bone Screw Mechanical Stability Test | This verification test demonstrates that the small length EDX Bone Screw thread is stable in a bone model, and deflection remains within requirements when attached to a weighted Tracker Arm. | | ASTM F543 Annex A2 | This verification test demonstrates that, for the worst case EDX Bone screw, the maximum insertion and removal torque is ≤50% of the screw torsional yield strength. | ## Supporting Literature An ex-vivo (cadaver) study was performed at the system level and confirms comparable accuracy in placement of zygomatic implants to conventional length implants using the X-Guide® System. Supporting literature from the secondary predicate device (NaviDent) was also used examining the accuracy of placement of pterygoid and zygomatic implants comparing free-hand placement and navigated placement in patients receiving full-arch restorative plans. | Study Title | Description | | --- | --- | | The Use of Dynamic Navigation for the Placement of Zygoma Implants: A Cadaver Study to Compare Accuracy | This study demonstrates that dental surgeons can effectively perform zygoma implant procedures with the X-Guide. The test method compared dynamically navigated zygoma implant surgeries and freehanded zygoma implant surgeries in cadavers. The presurgical CBCT plan was compared to the navigated or freehanded trajectories in the post-operative CBCT. Both linear deviation and angular deviation were compared between the two experimental groups. The linear deviation and angular deviation in dynamically navigated zygoma implants were found to be better than freehand. The method assessing implant placement used in this study is well-established. It is the same as the method used in the predicate devices' 510(k) submissions, and involves a superimposition of the plan to the post-operative CT scan. | | Navigated Flapless Placement of Zygomatic Implants: A Randomized Controlled Trial | This randomized controlled trial evaluated 20 patients receiving zygomatic implants using dynamic navigation with the NaviDent system, comparing a flapless approach to the conventional flapped technique. The flapless technique allowed implant placement under local anesthesia without raising a mucoperiosteal flap, relying on real-time navigation to guide implant positioning and sinus membrane elevation. Implant survival was high in both groups, with only one implant failure among 40 zygomatic implants placed. The failure rate is consistent with previously published systematic reviews of zygomatic implant failure rates. Rates of sinus complications and | 1555 Bustard Road, Suite #75, Lansdale, PA 19446 267-436-0420 www.X-NavTech.com {20} X-NAV TECHNOLOGIES | | osseointegration were comparable between groups, and no postoperative neurosensory deficits were detected. | | --- | --- | | Comparative Evaluation of the Accuracy of Dynamic Navigation and Free Hand Methods During Zygomatic Implant Placement A Randomized Controlled Trial | The study provides published clinical evidence supports the use of dynamic navigation for zygomatic implant placement. In a randomized controlled clinical trial involving 40 zygomatic implants placed in patients with atrophic maxillae, dynamic navigation demonstrated significantly improved placement accuracy compared to freehand surgery at the implant entry point, apex, and angular position. Procedures were completed using the NaviDent system and dynamic navigation was compared to conventional flapped placement. | | Accuracy of Dynamic Navigation Surgery in the Placement of Pterygoid Implants | The study provides published clinical evidence demonstrates successful use of implant navigation for pterygoid implant placement in a prospective randomized clinical trial involving 63 pterygoid implants in 39 patients using the NaviDent system and a split mouth protocol when available. The study concluded that pterygoid implant surgery is a predictable and successful treatment modality for placement of steep implant angulation and that dynamic navigation significantly improved placement accuracy compared to free-hand surgery, including accuracy relative to critical anatomical structures. | ## Risk Analysis A Product Risk Analysis was conducted in accordance with ISO 14971 to review the following elements specific to the change: - The risks associated with the use, usability and performance of the device - the risks associated with and specific to the software design aspects of the device - the risks associated with software functionality and software interaction with the user - The risks associated with the new length EDX Bone Screws - The risks associated with navigating zygoma and pterygoid implants. Results were updated in the X-Guide Risk Analysis. ## Conclusions Based upon the information provided within this 510(k) Premarket Notification, we conclude that the X-Guide® Surgical Navigation System with Straight Cuts and ToolTrace, alongside removed contraindications, is substantially equivalent to the identified predicate device. 1555 Bustard Road, Suite #75, Lansdale, PA 19446 / 267-436-0420 / www.X-NavTech.com