510(k) Report

Devices descending from K072212

77 later devices reach Jet-X Bar System Clamps, Bars and Posts-MR Safe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213874MAVERICK External Fixation SystemSmith & Nephew, Inc.20221—
+1K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+1K181528Austin Miller Large External Fixation SystemAustin Miller Trauma, LLC20192—
+1K180580Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation DevicesSurgical Instrument Service and Savings, Inc.20180—
+1K171211OIC External Fixation SystemOrthopaedic Implant Company20170—
+1K132731Digifix External Fixation SystemVirak Orthopedic Research, LLC20141—
+1K113770Orthofix Galaxy Fixation SystemOrthofix Srl2012613
+1K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126—
+1K111155Xtrafix External Fixation SystemExtraortho, Inc.20119—
+1K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+1K100795Jet-X Bar System Clamps and Posts ReprocessingSmith & Nephew, Inc.20100—
+1K090926Smith & Nephew Rail SystemSmith & Nephew, Inc.200910—
+2K253291Excelsior SystemBlue Ocean Global20260—
+2K253202Hoffmann LRF SystemStryker GmbH20250—
+2K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+2K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+2K242452Monkey Bars Pin to Bar External Fixation SystemParagon 28, Inc.20240—
+2K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+2K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc.20220—
+2K210953SMART Taylor Spatial FrameSmith & Nephew, Inc.20212—
+2K200491Bfix Orthopedic External Fixator SystemsAike (Shanghai) Medical Instrument Co., Ltd.20210—
+2K193368Smart Correction SystemWishbone Medical, Inc.202031
+2K200518Pitkar External Fixation System - Rail MechanismS.H.Pitkar Orthotools Pvt., Ltd.20202—
+2K192465DigiFix Sterile KitVirak Orthopedics, LLC20190—
+2K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+2K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+2K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC20168—
+2K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+2K141760Orthofix Galaxy WristOrthofix Srl201401
+2K142052Orthofix Galaxy Unyco Diaphyseal Tibia KitOrthofix Srl201421
+2K142520Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based softwareSmith & Nephew, Inc.201431
+2K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl201432—
+2K140550Orthohub External Fixator SoftwareOrthohub, Inc.20145—
+2K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+2K113383Xtrafix External Fixation SystemExtraortho, Inc.20128—
+2K110069Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc.201118—
+3K253764ENOS Software Guided External Fixation SystemDisior, Ltd.20260—
+3K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+3K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+3K241357XT3 SystemBiodynamik, Inc.20251—
+3K231461Smart Correction System (HA Half Pins)Wishbone Medical, Inc.20231—
+3K223786Orthex External Fixation SystemOrthoPediatrics Corp.20232—
+3K221792Acute QC Strut and ComponentsSmith & Nephew, Inc.20220—
+3K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+3K212552Correx SoftwareVilex, LLC20210—
+3K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC20212—
+3K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+3K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+3K191241AutoStrutOrthospin20194—
+3K173883External Fixation SystemLife Spine, Inc.20180—
+3K153233Galaxy UNYCO SystemOrthofix Srl201611
+3K152755FastFrame External Fixation System-Ankle SpanningZimmer, Inc.20150—
+3K151992FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System -…Zimmer, Inc.20150—
+3K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+3K141697Xtrafix External Fixation System, Xtrafix Small External Fixation SystemZimmer, Inc.20141—
+3K131413Xtrafix Small External Fixation SystemZimmer, Inc.20142—
+4K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC20260—
+4K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+4K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.20260—
+4K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+4K202810AutoStrut G2Orthospin, Ltd.20213—
+4K170146Galaxy UNYCO SystemOrthofix Srl20170—
+4K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+4K152484FastFrame External Fixation System - Distal RadiusZimmer, Inc.20150—
+4K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl201519—
+5K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes20231—
+5K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+5K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+5K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+5K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl2017111
+6K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+6K242861TrueLok ElevateOrthofix Srl20243—
+6K233025Revolution External Plating SystemNew Standard Device Dba Metalogix20240—
+6K202833Sequel External Fixation DeviceSequel Medical, Inc.20211—
+6K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+7K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+7K251862External Fixation Bone DistractorParagon 28, Inc.20250—