510(k) Report

Devices descending from K093897

29 later devices reach Smith & Nephew Footprint 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—
+1K182264ICONN Revolution Knotless Suture AnchorIconn Orthopedics, LLC20180—
+1K173269KATOR Suture AnchorKator, LLC20182—
+1K180274Ventix Link Knotless Anchor with InserterCayenne Medical, Inc.20180—
+1K171964LigaMetrics Suture AnchorsMortise Medical, LLC20170—
+1K123579Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SLSmith & Nephew, Inc.20134—
+1K122314Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek OnlyCayenne Medical, Inc.20126—
+1K113274Footprint Ultra PK Suture AnchorSmith & Nephew, Inc.201216—
+1K112876Cufflink (TM) Knotless Anchor with Inserter, 4.5MM/5.5MM - Peek Only, Cufflink SP (TM)…Cayenne Medical, Inc.20117—
+1K110538Pro Fixation SystemSynovis Orthopedic & Woundcare20110—
+2K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd.20250—
+2K210498Betta Link Knotless Implant SystemT.A.G. Medical Products Corporation, Ltd.202101
+2K190915OsteoFab Suture AnchorsOxford Performance Materials, Inc.20190—
+2K182507Tigon Medical Tissue AnchorsTigon Medical20192—
+2K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+2K182736OIC Suture Anchor SystemThe Orthopaedic Implant Company20180—
+2K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.201562
+2K143392Quattro Bolt Tenodesis ScrewCayenne Medical, Inc.20150—
+3K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+3K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…Smith & Nephew, Inc.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—
+3K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.20230—
+3K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+3K220464Tigon Medical Gryphon Anchor LineTigon Medical20231—
+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—
+4K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—