{"id":13404,"date":"2026-05-29T21:00:00","date_gmt":"2026-05-29T19:00:00","guid":{"rendered":"http:\/\/stocks-future.com\/?guid=4db4d11aeebad062e131f1d47848c6ef"},"modified":"2026-05-29T21:00:00","modified_gmt":"2026-05-29T19:00:00","slug":"surgentec-secures-fda-clearance-for-ion-c-now-navigation-compatible","status":"publish","type":"post","link":"https:\/\/stocks-future.com\/?p=13404","title":{"rendered":"SurGenTec Secures FDA Clearance for ION-C\u2122 &#8211; Now Navigation Compatible"},"content":{"rendered":"<p>BOCA RATON, Fla.--(BUSINESS WIRE)--<a href=\"https:\/\/twitter.com\/hashtag\/CervicalSpine?src=hash\" >#CervicalSpine<\/a>--SurGenTec, LLC, a leader in innovative spine and orthopedic technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k)<\/p><br\/><a href=\"https:\/\/mms.businesswire.com\/media\/20260529194913\/en\/2817690\/5\/ion-c-navigation-post-v2.jpg\"><img src=\"https:\/\/mms.businesswire.com\/media\/20260529194913\/en\/2817690\/22\/ion-c-navigation-post-v2.jpg\" \/><\/a><br\/><a href=\"https:\/\/mms.businesswire.com\/media\/20260529194913\/en\/2817690\/5\/ion-c-navigation-post-v2.jpg\"><img src=\"https:\/\/mms.businesswire.com\/media\/20260529194913\/en\/2817690\/21\/ion-c-navigation-post-v2.jpg\" \/><\/a><br\/><a href=\"https:\/\/mms.businesswire.com\/media\/20260529194913\/en\/2817689\/5\/sgt-color-logo-black300ppi_1.jpg\"><img src=\"https:\/\/mms.businesswire.com\/media\/20260529194913\/en\/2817689\/22\/sgt-color-logo-black300ppi_1.jpg\" \/><\/a><br\/><a href=\"https:\/\/mms.businesswire.com\/media\/20260529194913\/en\/2817689\/5\/sgt-color-logo-black300ppi_1.jpg\"><img src=\"https:\/\/mms.businesswire.com\/media\/20260529194913\/en\/2817689\/21\/sgt-color-logo-black300ppi_1.jpg\" \/><\/a><p>\nSurGenTec, LLC, a leader in innovative spine and orthopedic technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its ION-C\u2122 navigation instruments for use with the ION-C\u2122 posterior cervical facet fixation implant. The system is engineered for compatibility with Medtronic\u2019s StealthStation\u2122 navigation platform, enabling enhanced precision during posterior cervical fusion procedures.<\/p><p>\nDesigned to support enhanced procedural accuracy and engineered for compatibility with navigation, the ION-C\u2122 navigation instruments are intended to assist surgeons in precisely locating anatomical structures \u2014 specifically the cervical facet joint \u2014 during open or minimally invasive spinal procedures to support implant placement and surgical workflow efficiency.<\/p><p>\nION-C\u2122 was engineered with a zero-profile implant design and controlled drill-to-implant geometry to support controlled, non-impact placement and implant depth accuracy. The system was developed to help maintain the facet joint in a neutral position while reducing the risk of unintended joint expansion during insertion, supporting controlled posterior cervical fixation while helping preserve native cervical alignment.<\/p><p>\nKey potential benefits of navigated ION-C\u2122 facet fixation include:<\/p><ul class=\"bwlistdisc\">\n<li>\nPrecision placement during cervical facet targeting<\/li>\n<li>\nImproved visualization of cervical anatomy and surrounding structures<\/li>\n<li>\nIncreased procedural control and surgical confidence<\/li>\n<li>\nPotential reductions in operative time, radiation exposure, and procedural complications<\/li>\n<\/ul><p>\nAs navigation-assisted spine procedures continue to evolve, the ION-C\u2122 navigation instruments represent another step forward in precision-driven cervical spine technology.<\/p><p>\n<b>Dr. Micah Smith, an orthopedic spine surgeon at Parkview Health in Fort Wayne, Indiana, stated:<\/b><\/p><p>\n\u201cThis is an exciting time in spine surgery as enabling technologies continue to support minimally invasive techniques and help reduce intraoperative radiation exposure. Navigation-assisted placement of ION-C may help surgeons improve visualization and workflow, particularly in anatomically challenging cases such as severely arthritic facet joints or levels where fluoroscopic imaging may be limited by patient anatomy. These capabilities are intended to support procedural accuracy and surgical efficiency.\u201d<\/p><p>\n<b>About SurGenTec, LLC<\/b><\/p><p>\nSurGenTec is a privately held medical device company dedicated to advancing spine and orthopedic surgery through innovative, minimally invasive technologies. Focused on improving clinical outcomes and addressing unmet needs in posterior cervical fixation, the company offers a comprehensive portfolio that includes the ION-C\u2122 Facet Fixation System featuring a zero-profile implant design and controlled drill-to-implant geometry, advanced bone graft solutions, and a range of precision-engineered implants and instruments designed to enhance surgical efficiency and performance. The navigation platform rollout will commence immediately.<\/p><br\/> <b>Contacts<\/b> <br\/><p>\n(561) 990-7882\n<br\/><a  href=\"mailto:customerservice@surgentec.com\" rel=\"nofollow\" shape=\"rect\">customerservice@surgentec.com<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>BOCA RATON, Fla.&#8211;(BUSINESS WIRE)&#8211;#CervicalSpine&#8211;SurGenTec, LLC, a leader in innovative spine and orthopedic technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k)<br \/>\nSurGenTec, LLC, a leader in innovative spin&#8230;<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-13404","post","type-post","status-publish","format-standard","hentry","category-infos-businesswire"],"_links":{"self":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/13404","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=13404"}],"version-history":[{"count":1,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/13404\/revisions"}],"predecessor-version":[{"id":13405,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/13404\/revisions\/13405"}],"wp:attachment":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=13404"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=13404"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=13404"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}