510(k) Report

Devices descending from K140550

5 later devices reach Orthohub External Fixator Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253764ENOS Software Guided External Fixation SystemDisior, Ltd.20260—
+1K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+2K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+3K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+3K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—