510(k) Report

Devices descending from K153656

13 later devices reach PathLoc-SI Joint Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+1K203373Advanced Research Medical Trident SI Screw SystemAdvanced Research Medical, LLC20210—
+1K181600PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201811—
+2K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+2K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+3K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+3K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+3K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+3K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+3K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+4K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+4K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+4K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—