510(k) Report

Devices descending from K192484

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203523Fixone hybrid knotless anchorAju Pharm Co., Ltd.202118
+1K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+2K230892Fixone Biocomposite AnchorAju Pharm Co., Ltd.202308