510(k) Report

Devices descending from K994143

127 later devices reach Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc.20220—
+1K221792Acute QC Strut and ComponentsSmith & Nephew, Inc.20220—
+1K213874MAVERICK External Fixation SystemSmith & Nephew, Inc.20221—
+1K210953SMART Taylor Spatial FrameSmith & Nephew, Inc.20212—
+1K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+1K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+1K113383Xtrafix External Fixation SystemExtraortho, Inc.20128—
+1K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126—
+1K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+1K102215Kirschner Wires, Steinman PinsEvergreen Orthopedic Research Lab20106—
+1K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+1K093753Mdpo Frame SystemMdpo, LLC20100—
+1K092002Afghan External FixatorSmith & Nephew, Inc.20090—
+1K091258Extrafix External Fixation SystemQfx Technologies, Inc.200911—
+1K090926Smith & Nephew Rail SystemSmith & Nephew, Inc.200910—
+1K070555Orthopro Steinman Pins and Kirschner WiresOrthopro, LLC200737—
+1K042436Iiizarov Pulley SystemSmith & Nephew, Inc.20048—
+1K031181External Fixation SystemsSmith & Nephew, Inc.200324—
+1K012193Amc Antimicrobial Pin/Wire SleeveSmith & Nephew, Inc.20022—
+2K253291Excelsior SystemBlue Ocean Global20260—
+2K253202Hoffmann LRF SystemStryker GmbH20250—
+2K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+2K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+2K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+2K202762Circular Fixation with Balanced Cable TransportSmith & Nephew, Inc.20200—
+2K193368Smart Correction SystemWishbone Medical, Inc.202031
+2K200518Pitkar External Fixation System - Rail MechanismS.H.Pitkar Orthotools Pvt., Ltd.20202—
+2K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+2K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+2K181528Austin Miller Large External Fixation SystemAustin Miller Trauma, LLC20192—
+2K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+2K163656Hoffmann LRF SystemStryker GmbH2017115
+2K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC20168—
+2K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH2016132
+2K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+2K152755FastFrame External Fixation System-Ankle SpanningZimmer, Inc.20150—
+2K151992FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System -…Zimmer, Inc.20150—
+2K142520Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based softwareSmith & Nephew, Inc.201431
+2K140961Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG201414—
+2K141697Xtrafix External Fixation System, Xtrafix Small External Fixation SystemZimmer, Inc.20141—
+2K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl201432—
+2K140550Orthohub External Fixator SoftwareOrthohub, Inc.20145—
+2K131413Xtrafix Small External Fixation SystemZimmer, Inc.20142—
+2K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG20131—
+2K130907Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG201315—
+2K130334Hoffmann LRF (Limb Reconstruction Frame System)Stryker Trauma AG201315—
+2K113006I-Fuse Hammer Toe SystemsOrthopro, LLC201227—
+2K113327Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Corp.2012173
+2K111155Xtrafix External Fixation SystemExtraortho, Inc.20119—
+2K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+2K110069Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc.201118—
+2K100795Jet-X Bar System Clamps and Posts ReprocessingSmith & Nephew, Inc.20100—
+2K022688Versabond AB Bone CementSmith & Nephew, Inc.200401
+2K022676Orthoguard AB Antimicrobial SleeveSmith & Nephew, Inc.20020—
+3K253764ENOS Software Guided External Fixation SystemDisior, Ltd.20260—
+3K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+3K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+3K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+3K241357XT3 SystemBiodynamik, Inc.20251—
+3K233025Revolution External Plating SystemNew Standard Device Dba Metalogix20240—
+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—
+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—
+3K182968Hoffmann LRF SystemStryker GmbH201910—
+3K173883External Fixation SystemLife Spine, Inc.20180—
+3K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+3K161753Hoffman LRF SystemStryker GmbH201612—
+3K152484FastFrame External Fixation System - Distal RadiusZimmer, Inc.20150—
+3K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+3K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201516—
+3K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+3K142585PhaLinx Hammertoe SystemWrightmedicaltechnologyinc20149—
+3K121004Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20122—
+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—
+4K203568Hoffmann LRF SystemStryker GmbH20218—
+4K202810AutoStrut G2Orthospin, Ltd.20213—
+4K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+4K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+4K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC20171—
+4K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+4K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl201519—
+4K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC201515—
+4K150252PHALINX Hammertoe SystemWrightmedicaltechnologyinc20156—
+5K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—
+5K233741Hoffmann LRF SystemStryker GmbH20231—
+5K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes20231—
+5K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc20210—
+5K212895Paragon 28 External Ring Fixation SystemParagon 28, Inc.20215—
+5K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+5K200840DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202032
+5K181872MIS Bunion SystemCrossroads Extremity Systems, LLC201914—
+5K182684HammerTechTM Fixation SystemFusion Orthopedics, LLC20180—