510(k) Report

Devices descending from K191344

8 later devices reach Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+1K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+1K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+2K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+2K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+2K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+3K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+3K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—