510(k) Report

Devices descending from K941048

46 later devices reach True/Lok Monolateral/Bilateral Fixator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212044TrueLok EvoOrthofix Srl20210—
+1K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl201432—
+1K052005R&R External Fixation SystemR&R Medical, Inc.200511—
+1K022423External Fixation RingRigid FX Orthopedics, Incorporated20020—
+2K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+2K193368Smart Correction SystemWishbone Medical, Inc.202031
+2K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+2K180832SALVATION External Fixation SystemWrightmedicaltechnologyinc20181—
+2K162033SALVATION External Fixation SystemWright Medical20173—
+2K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+2K153635SALVATION (R) External Fixation SystemWrightmedicaltechnologyinc20164—
+2K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+2K140158S.E.a.L. Fracture Fusion TubeDne, LLC20140—
+2K113106Dne External Fixation SystemDne, LLC20122—
+2K100137Sidekick Circular Fixator System: Struts and HingesWrightmedicaltechnologyinc20106—
+3K252555Medusa Orthopedics Boa External Fixation SystemMedusa Orthopedics, LLC20250—
+3K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+3K231461Smart Correction System (HA Half Pins)Wishbone Medical, Inc.20231—
+3K223786Orthex External Fixation SystemOrthoPediatrics Corp.20232—
+3K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+3K212552Correx SoftwareVilex, LLC20210—
+3K200343FusionFrame Ring Lock SystemGlw Medical Innovation20200—
+3K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+3K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+3K173883External Fixation SystemLife Spine, Inc.20180—
+3K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+3K151580D.N.E. External Fixation SystemDne, LLC201601
+3K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl201519—
+3K152045SALVATION® External Fixation SystemWrightmedicaltechnologyinc20150—
+4K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+4K253764ENOS Software Guided External Fixation SystemDisior, Ltd.20260—
+4K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+4K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+4K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+4K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+4K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+4K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl2017111
+5K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+5K242861TrueLok ElevateOrthofix Srl20243—
+5K233025Revolution External Plating SystemNew Standard Device Dba Metalogix20240—
+5K202833Sequel External Fixation DeviceSequel Medical, Inc.20211—
+5K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.20260—
+6K253291Excelsior SystemBlue Ocean Global20260—
+6K251862External Fixation Bone DistractorParagon 28, Inc.20250—