510(k) Report

Devices descending from K152566

6 later devices reach PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…Smith & Nephew, Inc.20250—
+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—
+1K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.20230—
+1K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+1K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited20220—