510(k) Report

Devices descending from K983942

198 later devices reach Intramedullary Nail System, Locking Screw, Nail Cap through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243608TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc.20250—
+1K163014AOS Small Bone Nailing SystemAdvanced Orthopaedic Solutions, Inc. (Aos)20171—
+1K111025Trigen Low Profile Bone ScrewSmith & Nephew, Inc.201151
+1K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+1K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.201031—
+1K083726Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp.2009627
+1K070761Sanatmetal Nails and PinsSanatmetal Mfr. of Orthopaedic/Traumatologic Prod.20083—
+1K061783Knee Fusion NailSmith & Nephew, Inc.20061—
+1K051557Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc.200569—
+1K050882Newdeal Ankle NailNew Deal, S.A.2005155
+1K050938Knee Fusion NailSmith & Nephew, Inc.20054—
+1K040656Modification to Smith & Nephew Intramedullary Hip ScrewSmith & Nephew, Inc.20049—
+1K040929Trigen Adolescent TanSmith & Nephew, Inc.20049—
+1K040462Trigen Trochanteric Antegrade NailSmith & Nephew, Inc.2004132
+1K040212Trigen IntertanSmith & Nephew, Inc.20041216
+1K032722Trigen Straight Humeral Nail SystemSmith & Nephew, Inc.2003100—
+1K023115Ace VersanailDePuy Orthopaedics, Inc.200241—
+1K021782BNFAap Implantate AG20020—
+2K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K240061TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemSmith & Nephew, Inc.20240—
+2K241804TRIGEN INTERTAN 10S Nail SystemSmith & Nephew, Inc.20240—
+2K234128Phantom Fibula Nail SystemParagon 28, Inc.202401
+2K233910Vertex Hip Fracture Nailing SystemOrthoxel Dac20240—
+2K230761TRIGEN META-NAIL Nail SystemSmith & Nephew, Inc.20232—
+2K210980Smith & Nephew Intramedullary Nail SystemsSmith & Nephew, Inc.202204
+2K211086The Progen™ Trochanteric Nail SystemOrtho Development Corporation20210—
+2K200869Gamma3 SystemStryker Trauma GmbH20209—
+2K192003Auxein Nailing SystemAuxein Medical Private Limited20202—
+2K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+2K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+2K172830Double Medical Femoral Nail SystemDouble Medical Technology, Inc.20182—
+2K172583OrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc.201843
+2K172699Agile NailOrthofix Srl20180—
+2K172157DePuy Synthes Femoral Recon Nail SystemSynthes (USA) Products, LLC20172—
+2K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc.20160—
+2K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+2K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+2K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+2K132830Distalock Tibial IM Nail SystemDgimed Ortho, Inc.20140—
+2K131636Polarus ConnectAcumed, LLC20130—
+2K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+2K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+2K123948China Nails and AccessoriesSmith & Nephew, Inc.20130—
+2K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc.201201
+2K121575Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited201211
+2K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+2K113828Dynanail Ankle Arthrodesis NailMedShape, Inc.201224—
+2K120083Set Screw for TI Trochanteric Fixation Nail (TFN)Synthes USA20123—
+2K101934Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models 1200-01-1222…Medshape Solutions201125—
+2K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+2K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+2K101939Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation SystemMerete Medical GmbH201001
+2K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+2K092748Sureshot Tan Nails and AccessoriesSmith & Nephew, Inc.201041
+2K091788Panta Nail (Dia. 10MM), Panta Nail XLNewdeal Sas2009142
+2K083648Gotfried Physiological Hip (PH) NailEfratgo, Ltd. HI Tech Bio-Surgical20090—
+2K082754Aequalis Humeral Nail SystemTornier2009222
+2K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc.200835—
+2K061019Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc.2006601
+2K050226Asian Intramedullary Hip Screw NailsSmith & Nephew, Inc.20057—
+3K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—
+3K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.20260—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.20260—
+3K253517Reselute Tibial NailReselute, Inc.20260—
+3K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+3K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+3K250622Succession™ AFN SystemOrtho Solutions UK, Ltd.20250—
+3K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+3K242247ARIX Femur Nail SystemJeil Medical Corporation20251—
+3K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.20251—
+3K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+3K243364TRIGEN META-TAN Trochanteric Antegrade NailSmith & Nephew, Inc.20241—
+3K230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail…Tdm Co., Ltd.20240—
+3K233134I.T.S. INS Proximal Femur NailI.T.S. GmbH20240—
+3K221031Arthrex DualCompression Hindfoot Fusion Nail Implant SystemArthrex, Inc.20220—
+3K221021Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A20220—
+3K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+3K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc.20221—
+3K220679Pediatric Nailing Platform FemurOrthoPediatrics Corp.20222—
+3K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+3K210792Auxein Nailing SystemAuxein Medical Private Limited20210—
+3K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+3K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+3K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+3K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+3K190321Pediatric Nailing PlatformFemurOrthoPediatrics Corp.20190—
+3K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—
+3K182677DynaNail MiniMedShape, Inc.20195—
+3K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+3K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes20182—
+3K181639Panta 2 Arthrodesis Nail SystemIntegra LifeSciences Corporation20180—
+3K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics20181—
+3K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+3K173811TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis SystemIn2bones Sas20181—
+3K171108AUTOBAHN Nailing SystemGlobus Medical, Inc.20172—
+3K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+3K170972Apex Tibial Nailing SystemOrthoxel20171—
+3K171376DynaNail TTC Fusion SystemMedShape, Inc.201722—
+3K163589SIGN IM NailSign Fracture Care International20170—