510(k) Report

Devices descending from K113274

16 later devices reach Footprint Ultra PK Suture Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+1K173269KATOR Suture AnchorKator, LLC20182—
+1K171964LigaMetrics Suture AnchorsMortise Medical, LLC20170—
+1K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.201562
+1K123579Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SLSmith & Nephew, Inc.20134—
+2K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…Smith & Nephew, Inc.20250—
+2K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd.20250—
+2K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd.20250—
+2K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+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—
+2K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+2K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited20220—
+2K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+2K182736OIC Suture Anchor SystemThe Orthopaedic Implant Company20180—
+3K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—