510(k) Report

Devices descending from K920213

109 later devices reach Mitek Anchor, Mitek Anchor II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K231891Virtue Male Sling System with Alexis Wound Retractor Convenience KitColoplast20230—
+8K222423Fixone All Suture AnchorAju Pharm Co., Ltd.202308
+8K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+8K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+8K183236Rotium Bioresorbable WickNanofiber Solutions, LLC20193—
+8K172921Stryker Self-Punching ICONIXStryker20170—
+9K241912BiochargeNanofiber Solutions, LLC20240—
+9K231641Rotium Bioresorbable WickNanofiber Solutions, LLC20231—
+9K201414Rotium Bioresorbable WickNanofiber Solutions, LLC20202—