← Product Code [OLO](/productcode/OLO) · K261410 # Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) (K261410) _Suite 201, National Innovation Centre · OLO · Jul 30, 2026 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K261410 ## Device Facts - **Applicant:** Suite 201, National Innovation Centre - **Product Code:** [OLO](/productcode/OLO.md) - **Decision Date:** Jul 30, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.4560 - **Device Class:** Class 2 - **Review Panel:** Neurology ## Indications for Use The Navbit MARQ System is a computer-controlled system intended to assist the surgeon in determining alignment in relation to reference axes during orthopedic surgical procedures. The Navbit MARQ System facilitates the accurate positioning of implants, relative to these alignment axes. The clinical setting and target population for the Navbit MARQ System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the patient in a supine or lateral decubitus position. The Navbit MARQ System is indicated for use: - in Hip Arthroplasty surgical procedures; - with acetabular cups that are uncemented and allow for post-impaction correction; - when post-impaction confirmatory measurement checks can be obtained. ## Device Story Computer-assisted surgical navigation system for hip arthroplasty; assists surgeons in determining acetabular cup alignment. System comprises battery-powered inertial navigation unit (MARQ device), bone pin assembly, and impactor fitting assembly. Device uses MEMS IMU (accelerometers/gyroscopes) to calculate real-time inclination and anteversion angles. Operated by surgeon in OR; requires registration in supine or lateral position. Output displayed on integrated OLED screen; provides real-time guidance for implant positioning. Confirmatory measurements obtained post-impaction. Single-use, sterile, disposable device. Benefits include improved accuracy of implant positioning relative to reference axes. ## Clinical Evidence No clinical trials performed. Evidence based on non-clinical bench testing and simulated-use cadaver studies. Testing included software V&V (IEC 62304), hardware V&V, sterilization (ISO 11135), biocompatibility (ISO 10993-1), electrical safety/EMC (IEC 60601-1/1-2), usability (IEC 62366-1), and system accuracy (ASTM F2554). All testing met predetermined acceptance criteria. ## Technological Characteristics MEMS-based inertial navigation unit; includes accelerometers and gyroscopes. Features OLED display, Hall-effect sensor, and mechanical activation button. Single-use, EO-sterilized. Powered by internal battery. Software Class B per IEC 62304. System accuracy tested per ASTM F2554. ## Regulatory Identification A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system. ## Predicate Devices - Navbit Sprint ([K200376](/device/K200376.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} **FDA** U.S. FOOD & DRUG ADMINISTRATION July 30, 2026 Suite 201, National Innovation Centre David Thomson Navbit Pty Ltd 4 Cornwallis Street South Eveleigh Nsw, 2015 Australia Australia Re: K261410 Trade/Device Name: Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 30, 2026 Received: April 30, 2026 Dear David Thomson: 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} K261410 - David Thomson 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 {2} K261410 - David Thomson Page 3 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-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, 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 | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | | K261410 | ? | | --- | --- | --- | --- | | Please provide the device trade name(s). | | | ? | | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) | | | | | Please provide your Indications for Use below. | | | ? | | The Navbit MARQ System is a computer-controlled system intended to assist the surgeon in determining alignment in relation to reference axes during orthopedic surgical procedures. The Navbit MARQ System facilitates the accurate positioning of implants, relative to these alignment axes. The clinical setting and target population for the Navbit MARQ System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the patient in a supine or lateral decubitus position. The Navbit MARQ System is indicated for use: - in Hip Arthroplasty surgical procedures; - with acetabular cups that are uncemented and allow for post-impaction correction; - when post-impaction confirmatory measurement checks can be obtained. | | | | | 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) | ? | | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | | Page 1 of 1. {4} navbit navbit.pty.ltd | info@navbit.com | +61 02 9209 4130 Suite 201, National Innovation Centre, 4 Cornwallis Street, South Eveleigh, 2015, NSW, Australia # 510(k) Summary - K261410 Navbit MARQ — 510(k) Summary prepared in accordance with 21 CFR 807.92 # 1. Submission Information | Field | Value | | --- | --- | | Submitter | Navbit Pty Ltd, Suite 201, National Innovation Centre, 4 Cornwallis Street, South Eveleigh, NSW 2015, Australia | | Contact | David Geoffrey Thomson, Chief Regulatory & Commercial Risk Officer, dave.thomson@navbit.com, +61 433 482 325 | | Product Code | OLO: Stereotaxic Instrument | | Class | II | | Classification Reference | 21 CFR 882.4560 | | Common/Usual Name | Stereotaxic instrument | | Proprietary Name | Navbit MARQ | | Predicate Device(s) | Navbit Sprint (K200376) | | Reason for Submission | New Device | # 2. Intended Use and Indications for Use # For Lateral Patient Registration The Navbit MARQ System is a computer-controlled system intended to assist the surgeon in determining alignment in relation to reference axes during orthopedic surgical procedures. The Navbit MARQ System facilitates the accurate positioning of implants, relative to these alignment axes. The clinical setting and target population for the Navbit MARQ System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the patient in a lateral decubitus position. The Navbit MARQ System for lateral patient registration is indicated for use: in Hip Arthroplasty surgical procedures; with acetabular cups that are uncemented and allow for post-impaction correction; when post-impaction confirmatory measurement checks can be obtained. # For Supine Patient Registration The Navbit MARQ System is a computer-controlled system intended to assist the surgeon in determining alignment in relation to reference axes during orthopedic surgical procedures. The Navbit MARQ System facilitates the accurate positioning of implants, relative to these alignment axes. The clinical setting and target population for the Navbit MARQ System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the patient in a supine position. The Navbit MARQ System for supine patient registration is indicated for use: in Hip Arthroplasty surgical procedures; with acetabular cups that are uncemented and allow for post-impaction correction; when post-impaction confirmatory measurement checks can be obtained. Navbit® MARQ™ K261410, Page 1 of 3. navbit.com {5} navbit navbit.pty.ltd | info@navbit.com | +61 02 9209 4130 Suite 201, National Innovation Centre, 4 Cornwallis Street, South Eveleigh, 2015, NSW, Australia ### 3. Device Description The Navbit MARQ System is a computer-assisted surgical navigation system for use in hip arthroplasty procedures. The system comprises three principal components: (1) the MARQ Device, a battery-powered inertial navigation unit with a high-contrast OLED display, mechanical button, and Hall-effect sensor; (2) the Bone Pin Assembly; and (3) the Impactor Fitting Assembly. The MARQ Device utilises a MEMS inertial measurement unit (IMU) containing accelerometers and gyroscopes to generate real-time angular measurements (inclination and anteversion angles) used to guide acetabular cup implantation. The device requires registration in one of two acceptable patient positions — supine and lateral — and alignment guidelines are provided for each. The Navbit MARQ System is provided terminally sterilised (EO), single-use disposable. ### 4. Substantial Equivalence Comparison The device is substantially equivalent to the predicate Navbit Sprint (K200376). Both devices share the same fundamental technological characteristics: IMU-based inertial navigation with MEMS accelerometers and gyroscopes, bone-fixed reference frame registration, real-time angular measurement display, and confirmatory post-impaction measurement. The MARQ incorporates design changes relative to the Sprint, including an integrated single bone pin assembly, an OLED display, a mechanical push button activation, revised battery configuration, and a refined mechanical housing. None of these changes raise new questions of safety or effectiveness, as demonstrated through the performance, biocompatibility, and electrical safety testing presented in this submission. ### 5. Performance Data and Non-Clinical Testing Non-clinical testing included: - Software verification and validation per IEC 62304 (Class B) - System hardware verification/validation testing - Sterilisation validation (EO) per ISO 11135 and shipping validation per ASTM D4169 - Biocompatibility assessment per ISO 10993-1 - Electrical safety and EMC testing per IEC 60601-1 and IEC 60601-1-2 - Summative usability study per IEC 62366-1 - System accuracy testing per ASTM F2554 - Simulated-use cadaver testing All non-clinical testing met predetermined acceptance criteria, demonstrating equivalence of the MARQ to the predicate. The Navbit MARQ System demonstrated substantial equivalence to the Navbit Sprint in both system accuracy and simulated-use cadaver testing. Navbit® MARQ™ K261410, Page 2 of 3. navbit.com {6} **navbit** navbit.pty.ltd | info@navbit.com | +61 02 9209 4130 Suite 201, National Innovation Centre, 4 Cornwallis Street, South Eveleigh, 2015, NSW, Australia ## 6. Clinical and Animal Studies No clinical trial was required. Simulated-use testing on cadavers was performed. No animal studies were performed for the Navbit MARQ System. ## 7. Conclusion The Navbit MARQ System is substantially equivalent to the predicate device Navbit Sprint (K200376). All non-clinical testing — encompassing software, hardware, biocompatibility, electrical safety, sterilisation, usability, and performance — met acceptance criteria. Testing against the FDA-recognised consensus performance standard (ASTM F2554) and clinical validation using cadaver models has demonstrated that the Navbit MARQ is as safe and as effective as the predicate device for its intended use. Navbit® MARQ™ K261410, Page 3 of 3. navbit.com --- **Source:** [https://fda.innolitics.com/device/K261410](https://fda.innolitics.com/device/K261410) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com