510(k) Report

Devices descending from K000797

12 later devices reach Obl 2.0 MM Mini Tac Anchor, Model 10-1629-01 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.201562
+1K111000Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC20114—
+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—
+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—
+2K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited20220—
+2K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+2K212739ActiFlipParcus Medical, LLC20210—
+2K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC20203—
+3K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—