510(k) Report

Devices descending from K192709

3 later devices reach Fixone All Suture Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222423Fixone All Suture AnchorAju Pharm Co., Ltd.202308
+1K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+1K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—