510(k) Report

Devices descending from K981529

211 later devices reach Titanium Intramedullary Nail, Titanium Locking Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230761TRIGEN META-NAIL Nail SystemSmith & Nephew, Inc.20232—
+1K210980Smith & Nephew Intramedullary Nail SystemsSmith & Nephew, Inc.202204
+1K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc.201201
+1K111025Trigen Low Profile Bone ScrewSmith & Nephew, Inc.201151
+1K093707Dyna Locking Trochanteric Nail, Model NG0820U&I Corp.20101—
+1K092748Sureshot Tan Nails and AccessoriesSmith & Nephew, Inc.201041
+1K061783Knee Fusion NailSmith & Nephew, Inc.20061—
+1K061019Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc.2006601
+1K051557Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc.200569—
+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—
+1K021782BNFAap Implantate AG20020—
+1K013563Long Trochanteric Nail SystemDePuy Orthopaedics, Inc.20017054
+2K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K253517Reselute Tibial NailReselute, Inc.20260—
+2K243608TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc.20250—
+2K243364TRIGEN META-TAN Trochanteric Antegrade NailSmith & Nephew, Inc.20241—
+2K240061TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemSmith & Nephew, Inc.20240—
+2K241804TRIGEN INTERTAN 10S Nail SystemSmith & Nephew, Inc.20240—
+2K233910Vertex Hip Fracture Nailing SystemOrthoxel Dac20240—
+2K221084Dyna Locking Trochanteric Nail™Innosys20230—
+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—
+2K171108AUTOBAHN Nailing SystemGlobus Medical, Inc.20172—
+2K172157DePuy Synthes Femoral Recon Nail SystemSynthes (USA) Products, LLC20172—
+2K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc.20160—
+2K150867Affixus Tibial Nailing SystemBiomet, Inc.20153—
+2K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+2K132830Distalock Tibial IM Nail SystemDgimed Ortho, Inc.20140—
+2K123948China Nails and AccessoriesSmith & Nephew, Inc.20130—
+2K113695Ellipse Precice Trauma Nail SystemEllipse Technologies, Inc.201232
+2K120083Set Screw for TI Trochanteric Fixation Nail (TFN)Synthes USA20123—
+2K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa)2011181
+2K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+2K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+2K083648Gotfried Physiological Hip (PH) NailEfratgo, Ltd. HI Tech Bio-Surgical20090—
+2K083726Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp.2009627
+2K090091Olecranail Intramedullary Fixation SystemMylad Orthopedic Solutions, LLC20091—
+2K082754Aequalis Humeral Nail SystemTornier2009222
+2K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc.200835—
+2K070761Sanatmetal Nails and PinsSanatmetal Mfr. of Orthopaedic/Traumatologic Prod.20083—
+2K070444Aos Tibial NailAdvanced Orthopaedic Solutions, Inc.20074—
+2K050226Asian Intramedullary Hip Screw NailsSmith & Nephew, Inc.20057—
+2K042325Trochanteric Nail SystemDePuy Orthopaedics, Inc.20041011
+2K033329Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc.200353—
+2K021008Advanced Orthopaedic Solutions Trochanteric NailAdvanced Orthopaedic Solutions, Inc.20021312
+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—
+3K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+3K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+3K242247ARIX Femur Nail SystemJeil Medical Corporation20251—
+3K230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail…Tdm Co., Ltd.20240—
+3K233134I.T.S. INS Proximal Femur NailI.T.S. GmbH20240—
+3K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp.20232—
+3K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+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—
+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—
+3K202099AOS Galileo™ Trochanteric Nail SystemAdvanced Orthopaedic Solutions, Inc.20204—
+3K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+3K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—
+3K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes20182—
+3K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics20181—
+3K172830Double Medical Femoral Nail SystemDouble Medical Technology, Inc.20182—
+3K172583OrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc.201843
+3K172699Agile NailOrthofix Srl20180—
+3K170972Apex Tibial Nailing SystemOrthoxel20171—
+3K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+3K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+3K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+3K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+3K140601Flow-NailFlow-Fx, LLC20142—
+3K141447Precice Trauma Nail SystemEllipse Technologies, Inc.20142—
+3K133081Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…Advanced Orthopaedic Solutions, Inc.20132—
+3K133376Aequalis Humeral Nail; Sizes 7MM & 8MM X 210, 230, 250, 270MM; Left and RightTornier, Inc.20133—
+3K131365T2 Tibial Nailing SystemStryker Trauma AG2013174
+3K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+3K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+3K13062512MM and 13MM Tibial NailsAdvanced Orthopaedic Solutions, Inc.20133—
+3K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+3K120148Aos Solid Locking Lag Screw, Aos Telescoping Lag ScrewAdvanced Orthopaedic Solutions, Inc.20126—
+3K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+3K111444Universal and Troch Entry Femoral Nailing Systems Line ExtensionDePuy Orthopaedics, Inc.20110—
+3K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+3K110322Olecra Intramedullary Fixation SystemMylad Orthopedic Solutions20110—
+3K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa)2011172
+3K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+3K103533ES Trochanteric Nail, Left and Right, 10MMAdvanced Orthopaedic Solutions, Inc.201111—
+3K101622Zimmer Natural Nail System Retrograde Femoral NailsZimmer, Inc.2010293
+3K100238HFN 125 Degree 9-13 MM, 180MM, HFN 130 Degree 9-13 MM, HFN RH 125 Degree 9-13MMDePuy Orthopaedics, Inc.20107250