NEXXT SPINE NAVIGATION System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the date March 31, 2022. The text is in a simple, sans-serif font and is horizontally aligned. The date is written out in full, with the month, day, and year clearly indicated. Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name in a sans-serif font. The seal is a circular emblem with a stylized image of a caduceus. Nexxt Spine LLC % Karen E. Warden President BackRoads Consulting Inc. PO Box 566 Chesterland, Ohio 44026 Re: K220291 Trade/Device Name: NEXXT SPINE NAVIGATION System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: January 31, 2022 Received: February 1, 2022 Dear Karen Warden: 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. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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, Shumaya Ali, MPH 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 {2}------------------------------------------------ ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K220291 Device Name NEXXT SPINE NAVIGATION System ## Indications for Use (Describe) The NEXXT SPINE NAVIGATION System is an instrumentation system intended to be used during preparation and placement of Nexxt Spine's INERTIA® Systems pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. | Type of Use (Select one or both, as applicable) | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> | 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](mailto: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}------------------------------------------------ ## 510(k) Summary | Date: | 28 March 2022 | |---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor: | Nexxt Spine, LLC | | | 14425 Bergen Blvd, Suite B | | | Noblesville, IN 46060 | | | Office: 317.436.7801 | | Sponsor Contact: | Andy Elsbury, President | | 510(k) Contact: | Karen E. Warden, PhD | | | BackRoads Consulting Inc. | | | PO Box 566 | | | Chesterland, OH 44026 | | | Office: 440.729.8457 | | Trade Name: | NEXXT SPINE NAVIGATION System | | Common Name: | Spinal navigation system | | Regulatory Class: | Class II | | Regulation Name, Regulation Number, Product Code: | Stereotaxic instrument, 882.4560, OLO | | Device Description: | The NEXXT SPINE NAVIGATION System is an instrumentation system which<br>includes taps and a probe, an awl and an inserter. The devices are used in<br>conjunction with the Medtronic® StealthStation Navigation System to assist with<br>placement of the Nexxt Spine INERTIA® Systems (INERTIA® Pedicle Screw and<br>INERTIA® Pedicle Screw and Deformity Correxxion System) pedicle screws. The<br>instruments are sold non-sterile and are reusable. | | Intended Use: | The NEXXT SPINE NAVIGATION System is an instrumentation system intended<br>to be used during preparation and placement of Nexxt Spine's INERTIA® Systems<br>pedicle screws during spinal surgery to assist the surgeon in precisely locating<br>anatomical structures in either open or minimally invasive procedures. These<br>instruments are designed for use with the Medtronic StealthStation® System,<br>which is indicated for any medical condition in which the use of stereotactic<br>surgery may be appropriate, and where reference to a rigid anatomical structure,<br>such as a vertebra, can be identified relative to a CT or MR based model,<br>fluoroscopy images, or digitized landmarks of the anatomy. | | Materials: | The NEXXT SPINE NAVIGATION System components are manufactured from<br>stainless steels as described by ASTM F899. | | Primary Predicate: | Navigated CD Horizon® Solera® Screwdrivers and Taps (Medtronic Sofamor<br>Danek, USA Inc. – K140454) | | Performance Data: | Navigation dimensional analysis and positional accuracy (per ASTM F2554)<br>validations were performed in side-by-side testing of the NEXXT SPINE<br>NAVIGATION System and predicate device. The test results demonstrate that the<br>NEXXT SPINE NAVIGATION System performance is substantially equivalent to<br>the predicate. | | Technological<br>Characteristics: | The NEXXT SPINE NAVIGATION System has the same technological<br>characteristics as the predicate device. Therefore the fundamental scientific<br>technology of the NEXXT SPINE NAVIGATION System is the same as previously<br>cleared devices. | | Conclusion: | The NEXXT SPINE NAVIGATION System possesses the same intended use and<br>technological characteristics as the predicate devices. Therefore the NEXXT<br>SPINE NAVIGATION System is substantially equivalent for its intended use. |