{"id":190787,"date":"2022-05-18T00:00:00","date_gmt":"2022-05-18T00:00:00","guid":{"rendered":"https:\/\/facfox.com\/news\/osseus-obtains-fda-510k-clearance-of-pisces-sa-spinal-implant-decision-makers\/"},"modified":"2022-05-27T09:19:24","modified_gmt":"2022-05-27T09:19:24","slug":"osseus-obtains-fda-510k-clearance-of-pisces-sa-spinal-implant-decision-makers","status":"publish","type":"post","link":"https:\/\/facfox.com\/news\/osseus-obtains-fda-510k-clearance-of-pisces-sa-spinal-implant-decision-makers\/","title":{"rendered":"Osseus Obtains FDA 510(k) Clearance of Pisces-SA Spinal Implant"},"content":{"rendered":"<p>Osseus, an innovative spinal solutions company, obtained FDA 510(k) clearance and launch of the Pisces-SA Standalone ALIF Interbody System. The Pisces-SA interbody can be used with both bone screws and alternative fixation bone anchors allowing for increased intraoperative flexibility.<\/p>\n<p><img decoding=\"async\" class=\"aligncenter\" src=\"https:\/\/img.facfox.com\/imgs\/2022\/05\/27\/cb4f4ec3e4070b10.png\" \/><\/p>\n<p>Bio<a href=\"https:\/\/facfox.com\/news\/topics\/mechanics\" target=\"_blank\" rel=\"noopener\">mechanic<\/a>al testing proved that the Pisces-SA anchors provide better expulsion resistance and perform comparably with traditional screw-based standalone ALIF constructs in stabilizing injured spinal segments. The Pisces-SA is the first of its kind to provide this level of expulsion resistance and segmental stabilization using an alternative fixation method.<\/p>\n<div style=\"background-color: #eaeaea7a; padding: 15px 30px; align-items: center; border-radius: 4px; margin-top: 1em; margin-bottom: 1em;\">\n<div style=\"flex: 1; padding-right: 30px;\">\n<h4 style=\"margin-bottom: 14px;\">Manufacturing on Demand<\/h4>\n<div>Online manufacturing service that meets your most stringent requirements. Get competitive quotes and put your parts into production.<\/div>\n<\/div>\n<p><a style=\"background-color: #0baee8; color: white; padding: 10px 20px; border-radius: 4px;\" href=\"https:\/\/facfox.com\" target=\"_self\" rel=\"noopener noreferrer\"><i class=\"fa-fw auxicon auxicon-cloud-upload\" aria-hidden=\"true\"><\/i> Get Quote<\/a><\/p>\n<\/div>\n<p>The Pisces-SA anchors allow for a streamlined, direct anterior approach which facilitates minimal access and improved operational efficiency. Dr. Michael Hisey, an orthopedic surgeon with Texas Back Institute in Plano, TX, describes the system\u2019s versatility, \u201cI\u2019ve used screws [\u2026], and I\u2019ve used the blade-type constructs, but I\u2019ve never used a device where you could make that choice intraoperatively. I really like that ability to make my decision at the time.\u201d<\/p>\n<p>This innovative platform integrates a highly porous 3D printed interbody with anatomical morphology designed for full osseointegration with streamlined instrumentation to facilitate a minimally invasive approach. Osseus believes the Pisces-SA sets the new standard for Standalone ALIF devices.<\/p>\n<div>\n<div><img decoding=\"async\" class=\"aligncenter\" src=\"https:\/\/img.facfox.com\/imgs\/2022\/05\/27\/9adf0db76372966f.png\" \/><\/div>\n<\/div>\n<p>\u201cReceiving FDA approval for the Pisces\u2122-SA is the culmination of relentless work from our R&amp;D dep<a href=\"https:\/\/facfox.com\/news\/topics\/art\" target=\"_blank\" rel=\"noopener\">art<\/a>ment and surgeon design team. We feel this product launch will solidify Osseus as one of the leading innovators in the spine industry,\u201d says Rob Pace, Founder and CEO of Osseus. \u201cSince our inception, we have pushed the envelope creating minimally invasive products to help simplify and streamline procedures. This product hits that mark, and we are excited to introduce it to the market. This is a special day for our company and for the team of surgeons who have provided extensive input on this groundbreaking product.\u201d<\/p>\n<div><\/div>\n<p>&nbsp;<\/p>\n<p style=\"font-size: 14px; color: grey;\">* This article is reprinted from <a href=\"https:\/\/www.3dprintingmedia.network\/osseus-obtains-fda-510k-clearance-of-pisces-sa-spinal-implant\/\" target=\"_blank\" rel=\"noopener\">3D Printing Media Network<\/a>. If you are involved in infringement, please contact us to delete it.<\/p>\n<p><i class=\"far fa-fw fa-user\"><\/i> Author:\u00a03D Printing Media Network<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Osseus, an innovative spinal solutions company, obtained FDA 510(k) clearance and launch of the Pisces-SA Standalone ALIF Interbody System. The Pisces-SA interbody can be used with both bone screws and alternative fixation bone anchors allowing for increased intraoperative flexibility.<\/p>\n","protected":false},"author":3,"featured_media":190891,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"fifu_image_url":"https:\/\/img.facfox.com\/imgs\/2022\/05\/27\/cb4f4ec3e4070b10.png","fifu_image_alt":"Osseus obtains FDA 510(k) clearance of Pisces-SA spinal implant Decision Makers","footnotes":""},"categories":[195],"tags":[24,127,129,3385],"class_list":["post-190787","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical","tag-3d-printing","tag-implant","tag-medical","tag-orthopedic"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Osseus Obtains FDA 510(k) Clearance of Pisces-SA Spinal Implant - FacFox News<\/title>\n<meta name=\"description\" content=\"Osseus, an innovative spinal solutions company, obtained FDA 510(k) clearance and launch of the Pisces-SA Standalone ALIF Interbody System. The Pisces-SA interbody can be used with both bone screws and alternative fixation bone anchors allowing for increased intraoperative flexibility. Osseus, an innovative spinal solutions company, obtained FDA 510(k) clearance and launch of the Pisces-SA Standalone ALIF Interbody System.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/facfox.com\/news\/osseus-obtains-fda-510k-clearance-of-pisces-sa-spinal-implant-decision-makers\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Osseus Obtains FDA 510(k) Clearance of Pisces-SA Spinal Implant\" \/>\n<meta property=\"og:description\" content=\"Osseus, an innovative spinal solutions company, obtained FDA 510(k) clearance and launch of the Pisces-SA Standalone ALIF Interbody System. The Pisces-SA interbody can be used with both bone screws and alternative fixation bone anchors allowing for increased intraoperative flexibility. Osseus, an innovative spinal solutions company, obtained FDA 510(k) clearance and launch of the Pisces-SA Standalone ALIF Interbody System.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/facfox.com\/news\/osseus-obtains-fda-510k-clearance-of-pisces-sa-spinal-implant-decision-makers\/\" \/>\n<meta property=\"og:site_name\" content=\"FacFox News\" \/>\n<meta property=\"article:published_time\" content=\"2022-05-18T00:00:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-05-27T09:19:24+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/img.facfox.com\/imgs\/2022\/05\/27\/cb4f4ec3e4070b10.png\" \/>\n<meta name=\"author\" content=\"Vera\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:image\" content=\"https:\/\/img.facfox.com\/imgs\/2022\/05\/27\/cb4f4ec3e4070b10.png\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Vera\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/facfox.com\/news\/osseus-obtains-fda-510k-clearance-of-pisces-sa-spinal-implant-decision-makers\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/facfox.com\/news\/osseus-obtains-fda-510k-clearance-of-pisces-sa-spinal-implant-decision-makers\/\"},\"author\":{\"name\":\"Vera\",\"@id\":\"https:\/\/facfox.com\/news\/#\/schema\/person\/7b701aad2d8f434034fcecd2c50a570c\"},\"headline\":\"Osseus Obtains FDA 510(k) Clearance of Pisces-SA Spinal Implant\",\"datePublished\":\"2022-05-18T00:00:00+00:00\",\"dateModified\":\"2022-05-27T09:19:24+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/facfox.com\/news\/osseus-obtains-fda-510k-clearance-of-pisces-sa-spinal-implant-decision-makers\/\"},\"wordCount\":362,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/facfox.com\/news\/#organization\"},\"image\":{\"@id\":\"https:\/\/facfox.com\/news\/osseus-obtains-fda-510k-clearance-of-pisces-sa-spinal-implant-decision-makers\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/img.facfox.com\/imgs\/2022\/05\/27\/cb4f4ec3e4070b10.png\",\"keywords\":[\"3d printing\",\"implant\",\"medical\",\"orthopedic\"],\"articleSection\":[\"Medical\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/facfox.com\/news\/osseus-obtains-fda-510k-clearance-of-pisces-sa-spinal-implant-decision-makers\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/facfox.com\/news\/osseus-obtains-fda-510k-clearance-of-pisces-sa-spinal-implant-decision-makers\/\",\"url\":\"https:\/\/facfox.com\/news\/osseus-obtains-fda-510k-clearance-of-pisces-sa-spinal-implant-decision-makers\/\",\"name\":\"Osseus Obtains FDA 510(k) Clearance of Pisces-SA Spinal Implant - FacFox News\",\"isPartOf\":{\"@id\":\"https:\/\/facfox.com\/news\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/facfox.com\/news\/osseus-obtains-fda-510k-clearance-of-pisces-sa-spinal-implant-decision-makers\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/facfox.com\/news\/osseus-obtains-fda-510k-clearance-of-pisces-sa-spinal-implant-decision-makers\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/img.facfox.com\/imgs\/2022\/05\/27\/cb4f4ec3e4070b10.png\",\"datePublished\":\"2022-05-18T00:00:00+00:00\",\"dateModified\":\"2022-05-27T09:19:24+00:00\",\"description\":\"Osseus, an innovative spinal solutions company, obtained FDA 510(k) clearance and launch of the Pisces-SA Standalone ALIF Interbody System. 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