510(k) Report

Devices descending from K032197

20 later devices reach Twin Fix AB 6.5 MM Suture Anchor, Models 720209, 7210210, 7210211, 7210212 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc.20134—
+1K093844Smith & Nephew Twinfix Ultra HA Suture AnchorSmith & Nephew, Inc.20101611
+2K193558HEALICOIL Knotless Suture AnchorsSmith & Nephew, Inc.20200—
+2K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…Smith & Nephew, Inc.2015140
+2K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc.201501
+2K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc.201213—
+3K193245Dunamis PunchTac Suture AnchorsDunamis, LLC20200—
+3K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+3K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc.20170—
+3K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.201562
+4K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…Smith & Nephew, Inc.20250—
+4K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd.20250—
+4K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd.20250—
+4K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+4K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.20230—
+4K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+4K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+4K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited20220—
+4K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+5K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—