510(k) Report

Devices descending from K141078

32 later devices reach Orthofix TL-Hex True Lok Hexalobe System (TL-Hex) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+1K193368Smart Correction SystemWishbone Medical, Inc.202031
+1K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+1K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+1K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+2K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+2K231461Smart Correction System (HA Half Pins)Wishbone Medical, Inc.20231—
+2K223786Orthex External Fixation SystemOrthoPediatrics Corp.20232—
+2K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+2K212552Correx SoftwareVilex, LLC20210—
+2K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+2K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+2K173883External Fixation SystemLife Spine, Inc.20180—
+2K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+2K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl201519—
+3K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+3K253764ENOS Software Guided External Fixation SystemDisior, Ltd.20260—
+3K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+3K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+3K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+3K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+3K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+3K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl2017111
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K242861TrueLok ElevateOrthofix Srl20243—
+4K233025Revolution External Plating SystemNew Standard Device Dba Metalogix20240—
+4K202833Sequel External Fixation DeviceSequel Medical, Inc.20211—
+4K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.20260—
+5K253291Excelsior SystemBlue Ocean Global20260—
+5K251862External Fixation Bone DistractorParagon 28, Inc.20250—