{"id":134,"date":"2023-12-28T18:03:32","date_gmt":"2023-12-28T18:03:32","guid":{"rendered":"https:\/\/inovedisusdev.wpenginepowered.com\/?page_id=134"},"modified":"2026-01-29T18:57:38","modified_gmt":"2026-01-29T18:57:38","slug":"sinefix-shoulder-surgery","status":"publish","type":"page","link":"https:\/\/inovedis.com\/index.php\/sinefix-shoulder-surgery\/","title":{"rendered":"SINEFIX Implant"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;RGBA(255,255,255,0)&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_direction=&#8221;152deg&#8221; background_color_gradient_stops=&#8221;rgba(172,174,176,0.15) 0%|rgba(172,174,176,0.37) 100%&#8221; background_image=&#8221;https:\/\/inovedis.com\/wp-content\/uploads\/2024\/02\/Inovedis-BKDG-Dots15.png&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_horizontal_offset=&#8221;-15%&#8221; custom_padding=&#8221;25px||25px||false|false&#8221; background_last_edited=&#8221;on|phone&#8221; background_size_phone=&#8221;cover&#8221; background_position_tablet=&#8221;top_right&#8221; background_position_phone=&#8221;top_right&#8221; background_horizontal_offset_tablet=&#8221;20%&#8221; background_horizontal_offset_phone=&#8221;11%&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;2_3,1_3&#8243; custom_padding_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;||0px||false|false&#8221; custom_padding_tablet=&#8221;|18%|||false|false&#8221; custom_padding_phone=&#8221;|0%|||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;2_3&#8243; _builder_version=&#8221;4.23.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; header_font=&#8221;||||||||&#8221; header_text_color=&#8221;#000000&#8243; header_letter_spacing=&#8221;1px&#8221; header_2_text_color=&#8221;#000000&#8243; header_3_font=&#8221;|600|||||||&#8221; header_3_text_color=&#8221;#00729A&#8221; custom_margin=&#8221;||9px||false|false&#8221; custom_padding=&#8221;||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h1 style=\"font-size: 65px; line-height: 1.1em;\">Simplifying<br \/>Shoulder Surgery<\/h1>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; header_font=&#8221;||||||||&#8221; header_letter_spacing=&#8221;1px&#8221; header_2_text_color=&#8221;#000000&#8243; header_3_font=&#8221;||||||||&#8221; header_3_text_color=&#8221;#000000&#8243; custom_margin=&#8221;||5px||false|false&#8221; custom_padding=&#8221;||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3 style=\"font-size: 18px; line-height: 1.5em;\">The SINEFIX\u2122 implant was designed to replace traditional suture anchors that require complex and time-consuming steps and address the <a href=\"\/suture-anchor-challenges\">shortcomings<\/a> of suture-based fixation.<\/h3>\n<h3 style=\"font-size: 18px; line-height: 1.5em;\">SINEFIX represents a completely different approach to rotator cuff repair. Instead of threads cutting through tendon, it uses a small polyether-ether-ketone (PEEK) implant that effectively \u201cstaples\u201d the tendon to bone over a broad area. The implant consists of a base plate with teeth on the underside that sits on the tendon surface and small fixation prongs that are driven into bone, clamping the tendon down. <\/h3>\n<h3 style=\"font-size: 18px; line-height: 1.5em;\">The SINEFIX design is aimed at eliminating the point-loading of sutures\u2014there are no concentrated suture anchor points, and at distributing the pressure is evenly across the repair footprint.<\/h3>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.23.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/inovedis.com\/wp-content\/uploads\/2023\/12\/Sinefix.png&#8221; alt=&#8221;Sinefix&#8221; title_text=&#8221;Sinefix&#8221; align=&#8221;right&#8221; _builder_version=&#8221;4.27.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;70%&#8221; custom_padding=&#8221;5px||||false|false&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][et_pb_image src=&#8221;https:\/\/inovedis.com\/wp-content\/uploads\/2024\/08\/SINEFIX-InHand.png&#8221; alt=&#8221;SINEFIX&#8221; title_text=&#8221;SINEFIX-InHand&#8221; align=&#8221;center&#8221; _builder_version=&#8221;4.27.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;98%&#8221; module_alignment=&#8221;center&#8221; custom_margin=&#8221;||||false|false&#8221; custom_padding=&#8221;25px||||false|false&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][et_pb_text _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h4 style=\"font-size: 14px; line-height: 3em; text-align: center;\">FDA Cleared<\/h4>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;25px||35px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;2_5,3_5&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;2_5&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/inovedis.com\/wp-content\/uploads\/2025\/09\/Sinefix-Shoulder-Surgery-System-091025.png&#8221; alt=&#8221;Sinefix Shoulder Surgery System&#8221; title_text=&#8221;Sinefix-Shoulder-Surgery-System-091025&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; width=&#8221;88%&#8221; module_alignment=&#8221;center&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][ba_image_compare before_img=&#8221;https:\/\/inovedis.com\/wp-content\/uploads\/2026\/01\/SINEFIX-Compare-0126.jpg&#8221; before_label=&#8221;SINEFIX&#8221; before_label_bg=&#8221;rgba(255,255,255,0.75)&#8221; after_img=&#8221;https:\/\/inovedis.com\/wp-content\/uploads\/2024\/04\/TraditionalRepair-Compare-0424.jpg&#8221; after_label=&#8221;Traditional&#8221; after_label_bg=&#8221;rgba(255,255,255,0.75)&#8221; offset_pct=&#8221;0.4&#8243; move_on_hover=&#8221;on&#8221; label_padding=&#8221;2px|15px|2px|15px|false|false&#8221; handle_style=&#8221;handle-2&#8243; handle_color=&#8221;#FFFFFF&#8221; arrow_color=&#8221;#F15F3F&#8221; _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;default&#8221; label_font=&#8221;Bebas Neue||||||||&#8221; label_text_color=&#8221;#000000&#8243; max_width=&#8221;100%&#8221; hover_enabled=&#8221;0&#8243; border_width_all_label=&#8221;1px&#8221; border_color_all_label=&#8221;#F15F3F&#8221; border_color_all_main=&#8221;#F15F3F&#8221; global_colors_info=&#8221;{}&#8221; alt=&#8221;SINEFIX Shoulder Surgery&#8221; title_text=&#8221;SINEFIX-Compare-0126&#8243; sticky_enabled=&#8221;0&#8243;][\/ba_image_compare][\/et_pb_column][et_pb_column type=&#8221;3_5&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#000000&#8243; header_font=&#8221;||||||||&#8221; header_letter_spacing=&#8221;1px&#8221; header_2_text_color=&#8221;#F15F3F&#8221; header_3_font=&#8221;|600|||||||&#8221; header_3_text_color=&#8221;#00729A&#8221; custom_margin=&#8221;||35px||false|false&#8221; custom_padding=&#8221;||||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2>Simple Surgical Technique<\/h2>\n<ul>\n<li>No knot tying or suture management required<\/li>\n<li>One SINEFIX implant can replace multiple suture anchors<\/li>\n<li>Expected to reduce surgery time and contribute to cost savings<\/li>\n<\/ul>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.27.0&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#000000&#8243; header_font=&#8221;||||||||&#8221; header_letter_spacing=&#8221;1px&#8221; header_2_text_color=&#8221;#F15F3F&#8221; header_3_font=&#8221;|600|||||||&#8221; header_3_text_color=&#8221;#00729A&#8221; custom_margin=&#8221;||35px||false|false&#8221; custom_padding=&#8221;||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2>Improved Tendon to Bone Fixation<\/h2>\n<ul>\n<li>Higher pull-out forces than double row fixation using less implants<\/li>\n<li>Minimizes punctual pressure aiming to reduce risk of loosening post surgery<\/li>\n<li>Demonstrates less gap formation than double row fixation to optimize contact pressure<\/li>\n<\/ul>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#000000&#8243; header_font=&#8221;||||||||&#8221; header_letter_spacing=&#8221;1px&#8221; header_2_text_color=&#8221;#F15F3F&#8221; header_3_font=&#8221;|600|||||||&#8221; header_3_text_color=&#8221;#00729A&#8221; custom_margin=&#8221;||5px||false|false&#8221; custom_padding=&#8221;||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2>Ensuring blood flow and facilitating healing<\/h2>\n<ul>\n<li>Gentle contact between tendon and bone aiming to prevent the creation of any acellular, necrotic zones in the tendon<\/li>\n<li>Even pressure load over the tendon ensuring good blood circulation<\/li>\n<li>Instrumentation designed to prevent excessive compression of tendon<\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_direction=&#8221;156deg&#8221; background_color_gradient_stops=&#8221;rgba(172,174,176,0.15) 0%|rgba(172,174,176,0.35) 100%&#8221; custom_padding=&#8221;25px||25px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;||5px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.27.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2 style=\"font-size: 45px; line-height: 1.2em;\"><span style=\"color: #acaeb0;\">BIOMECHANICAL EVALUATION<\/span><\/h2>\n<p>In a direct comparison, the new SINEFIX implant had higher pull-out forces and less gap formation than a double-row repair (DDR). 10 fresh sheep infraspinatus tendons were refixed with SINEFIX and DRR (2x medial and 1x lateral all-suture anchor) respectively.<\/p>\n<p>Methodology: after preloading with 10 N, the tendons were cyclically loaded with 10 to 62 N over 200 cycles at 0.2 Hz. The tendons, which were then still refixed, were loaded until they ruptured. View the <a href=\"https:\/\/inovedis.com\/wp-content\/uploads\/2024\/03\/DVSE_ePoster_Website_EN.pdf\" target=\"_blank\" rel=\"noopener\">poster<\/a>.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; use_custom_gutter=&#8221;on&#8221; gutter_width=&#8221;4&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;||||||||&#8221; text_text_color=&#8221;#000000&#8243; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2>Gap Formation:<\/h2>\n<p>Gap formation under cyclic loading up to 62 N[\/et_pb_text][et_pb_image src=&#8221;https:\/\/inovedis.com\/wp-content\/uploads\/2024\/02\/SINEFIX-GFormation.png&#8221; alt=&#8221;Pull Out Strength&#8221; title_text=&#8221;SINEFIX-GFormation&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][et_pb_text _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;10px&#8221; text_line_height=&#8221;1.5em&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>All (n=10) tendons refixed with SINEFIX survived cyclic loading up to 62N with a gap formation up to 1.49 millimeter (SD 0.84). In contrast, with the DRR method, one tendon remained less stable (n=9) with a gap formation of 3.19 millimeters (SD 0.91) (p=0.001).<\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;||||||||&#8221; text_text_color=&#8221;#000000&#8243; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2>Pullout Strength:<\/h2>\n<p>Pullout forces<\/p>\n<p>[\/et_pb_text][et_pb_image src=&#8221;https:\/\/inovedis.com\/wp-content\/uploads\/2024\/02\/SINEFIX-PulloutStrength.png&#8221; alt=&#8221;Pull Out Strength&#8221; title_text=&#8221;SINEFIX-PulloutStrength&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][et_pb_text _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;10px&#8221; text_line_height=&#8221;1.5em&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p >The maximum pullout forces with SINEFIX (n=6) were 215N (SD 55) versus DRR (n=4) with 166N (SD 15) (p=0.084).<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;4.25.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.25.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_divider color=&#8221;#ACAEB0&#8243; _builder_version=&#8221;4.25.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;||||false|false&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_divider][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;4.25.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;1px||10px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.25.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.25.0&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;10px&#8221; text_line_height=&#8221;1.5em&#8221; global_colors_info=&#8221;{}&#8221;]CAUTION: SINEFIX is intended for soft tissue to bone reattachment in rotator cuff repairs for tendon ruptures up to 2 cm. U.S. Federal law restricts this device to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device. SINEFIX is not approved for sale outside the U.S.[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.23.3&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;25px||25px||false|false&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.23.3&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.23.3&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; text_orientation=&#8221;center&#8221; custom_padding=&#8221;0px|||||&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2>Designed to address challenges with rotator cuff repair surgery<\/h2>\n<p>Learn more about SINEFIX and the<span style=\"color: #333333;\">\u00a0<a href=\"\/suture-anchor-challenges\/\" style=\"color: #333333;\">three main challenges<\/a><\/span> with rotator cuff repair surgery it addresses.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_3,1_3,1_3&#8243; _builder_version=&#8221;4.23.3&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;0px||||false|false&#8221; custom_padding=&#8221;0px||||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.23.3&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.23.3&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#00729A&#8221; text_font_size=&#8221;18px&#8221; header_text_align=&#8221;center&#8221; header_text_color=&#8221;#00729A&#8221; header_font_size=&#8221;28px&#8221; header_letter_spacing=&#8221;1px&#8221; header_4_text_color=&#8221;#FFFFFF&#8221; background_color=&#8221;#000000&#8243; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#8221;15px||4px||false|false&#8221; border_color_all=&#8221;RGBA(255,255,255,0)&#8221; border_width_bottom=&#8221;6px&#8221; border_color_bottom=&#8221;#00729A&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h4 style=\"text-align: center;\">Patient Outcomes<\/h4>\n<p>[\/et_pb_text][torq_flip_box front_media_type=&#8221;none&#8221; 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