510(k) Report

Devices descending from K011299

48 later devices reach Smith and Nephew 5.00MM Absorbable Polymer Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…Smith & Nephew, Inc.2015140
+1K110545Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)Smith & Nephew, Inc.201140—
+1K093844Smith & Nephew Twinfix Ultra HA Suture AnchorSmith & Nephew, Inc.20101611
+1K032197Twin Fix AB 6.5 MM Suture Anchor, Models 720209, 7210210, 7210211, 7210212Smith & Nephew, Inc.200320—
+2K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc.20170—
+2K133671Iconix All Suture AnchorsStryker Corp.201425—
+2K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc.20134—
+2K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc.201213—
+3K242529Tigon Medical All-Suture Anchors (ASA)Tigon Medical20242—
+3K240407ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture…Stryker Endoscopy20240—
+3K230094Responsive Arthroscopy Stealth and Mini Stealth All-Suture AnchorsResponsive Arthroscopy, LLC20231—
+3K221396Arthrex FiberTak Suture AnchorArthrex, Inc.20223—
+3K193558HEALICOIL Knotless Suture AnchorsSmith & Nephew, Inc.20200—
+3K193245Dunamis PunchTac Suture AnchorsDunamis, LLC20200—
+3K191227Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20201—
+3K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+3K171465Stryker Self-Punching ICONIXStryker20171—
+3K170098ICONIX TT All Suture AnchorStryker20173—
+3K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.201562
+3K151201Stryker ICONIX with NeedlesStryker201510—
+3K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc.201501
+4K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+4K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260—
+4K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical20251—
+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—
+4K250596Arthrex FiberTak Suture AnchorArthrex, Inc.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—
+4K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+4K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+4K231278Knotless Suture AnchorRiverpoint Medical, LLC202331
+4K230433Arthrex Knotless FiberTak Suture AnchorArthrex, Inc.20230—
+4K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+4K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited20220—
+4K211322Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20210—
+4K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+4K173074ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker20185—
+4K172921Stryker Self-Punching ICONIXStryker20170—
+5K262677Iconix Knotless TRiverpoint Medical20260—
+5K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+5K243323Iconix Knotless AnchorRiverpoint Medical20240—
+5K240213Iconix Knotless AnchorRiverpoint Medical20240—
+5K231078All-Suture AnchorRiverpoint Medical, LLC20233—
+6K241577Iconix® AnchorRiverpoint Medical20240—
+6K233468Iconix AnchorRiverpoint Medical20231—
+7K252144Iconix Speed Anchor; Iconix Speed HA+ AnchorRiverpoint Medical20250—