510(k) Report

Devices descending from K113294

23 later devices reach Smith & Nephew Healicoil PK Suture Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd.20250—
+1K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd.20250—
+1K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.201562
+1K143745Arthrex Corkscrew and SwiveLock Suture AnchorsArthrex, Inc.201510—
+1K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc.20134—
+2K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…Smith & Nephew, Inc.20250—
+2K231033CEPTRE® Knotted UHMWPE Suture PEEK AnchorHealthium Medtech Limited20240—
+2K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.20230—
+2K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+2K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+2K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited20220—
+2K202763Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20212—
+2K193558HEALICOIL Knotless Suture AnchorsSmith & Nephew, Inc.20200—
+2K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+2K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…Smith & Nephew, Inc.2015140
+2K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc.201501
+3K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+3K231322Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20231—
+3K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+3K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+3K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc.20170—
+4K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+4K243470Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20240—