510(k) Report

Devices descending from K152171

19 later devices reach Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193368Smart Correction SystemWishbone Medical, Inc.202031
+1K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+1K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+1K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl2017111
+2K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+2K242861TrueLok ElevateOrthofix Srl20243—
+2K233025Revolution External Plating SystemNew Standard Device Dba Metalogix20240—
+2K231461Smart Correction System (HA Half Pins)Wishbone Medical, Inc.20231—
+2K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+2K202833Sequel External Fixation DeviceSequel Medical, Inc.20211—
+2K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+2K173883External Fixation SystemLife Spine, Inc.20180—
+3K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+3K253764ENOS Software Guided External Fixation SystemDisior, Ltd.20260—
+3K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.20260—
+3K253291Excelsior SystemBlue Ocean Global20260—
+3K251862External Fixation Bone DistractorParagon 28, Inc.20250—
+3K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+3K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—