510(k) Report

Devices descending from K093228

19 later devices reach Smith & Nephew Twinfix Ultra PK Suture Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+1K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc.201213—
+1K100159Smith and Nephew Twinfix Ultra TI Suture AnchorSmith & Nephew Inc., Endoscopy Div.2010174
+2K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.20230—
+2K193558HEALICOIL Knotless Suture AnchorsSmith & Nephew, Inc.20200—
+2K193245Dunamis PunchTac Suture AnchorsDunamis, LLC20200—
+2K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+2K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.201562
+2K120356NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl20121—
+3K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…Smith & Nephew, Inc.20250—
+3K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd.20250—
+3K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd.20250—
+3K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+3K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+3K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+3K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited20220—
+3K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+3K160500Elite SPK, Compasso, Elite SPK KitNcs Lab Srl20160—
+4K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—