510(k) Report

Devices descending from K982953

121 later devices reach Titanium Intramedullary Nails-Various Styles through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151456Small Bone Nail ImplantVilex IN Tennessee, Inc.20150—
+1K072161Biomet Femoral Locking Nail SystemBiomet Manufacturing Corp2007228
+1K063570Biomet Tibial Locking Nail SystemBiomet Manufacturing Corp2007373
+1K042409Modular Arthrodesis NailBiomet, Inc.200402
+1K031438Acumed Small Bone Locking Rod System IIAcumed, LLC2003241
+1K023115Ace VersanailDePuy Orthopaedics, Inc.200241—
+1K021786Titanium Ankle Arthrodesis NailBiomet, Inc.2002271
+1K021782BNFAap Implantate AG20020—
+1K020962G4 Sleeved NailBiomet Manufacturing, Inc.20020—
+1K013923Titanium Retrograde Femoral Nail - 13 MM DiameterBiomet Orthopedics, Inc.20021—
+1K012190Aos Modular Femoral NailAdvanced Orthopaedic Solutions, Inc.200110—
+1K993956Titanium Pediatric Femoral NailBiomet, Inc.19991411
+2K252961Fusion FibFix NailFusion Orthopedics USA, LLC20260—
+2K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc.20260—
+2K243907Affixus Tibial Nailing System - 4mm screwsZimmer, Inc.20250—
+2K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc.2024217
+2K192003Auxein Nailing SystemAuxein Medical Private Limited20202—
+2K170972Apex Tibial Nailing SystemOrthoxel20171—
+2K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+2K163014AOS Small Bone Nailing SystemAdvanced Orthopaedic Solutions, Inc. (Aos)20171—
+2K160069Sonoma Fibula Repair SystemSonoma Orthopedics Products, Inc.20169—
+2K150867Affixus Tibial Nailing SystemBiomet, Inc.20153—
+2K143276Acumed Small Bone IM Nail SystemAcumed, LLC201510—
+2K142945Sonoma Fibula Repair SystemSonoma Orthopedic Products, Inc.201510—
+2K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+2K132005Retrograde Femoral NailAdvanced Orthopaedic Solutions, Inc.20134—
+2K123569Antegrade Femoral NailAdvanced Orthopaedic Solutions, Inc.20136—
+2K122823Sign Pediatric Fin NailSign Fracture Care International20130—
+2K121575Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited201211
+2K120419Dyna Locking Ankle NailU&I Corp.20129—
+2K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+2K113828Dynanail Ankle Arthrodesis NailMedShape, Inc.201224—
+2K111232Gap Endo-Exo Medullary SystemPega Medical, Inc.201271
+2K102413Fuze: Intramedullary Internal Fixation NailVilex, Inc.201173
+2K101934Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models 1200-01-1222…Medshape Solutions201125—
+2K091788Panta Nail (Dia. 10MM), Panta Nail XLNewdeal Sas2009142
+2K083726Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp.2009627
+2K081230Trauson Intramedullary NailTrauson (Jiangsu) Medical Instrument Co., Ltd.20090—
+2K081243Biomet Phoenix Ankle Nail SystemBiomet Trauma200818—
+2K070761Sanatmetal Nails and PinsSanatmetal Mfr. of Orthopaedic/Traumatologic Prod.20083—
+2K071944Acumed Small Bone Locking System IIAcumed, LLC200715—
+2K050882Newdeal Ankle NailNew Deal, S.A.2005155
+2K032548IP-XS Compression Nail SystemPlus Orthopedics20035—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K252196Arthrex FibuLock Nail SystemArthrex, Inc.20260—
+3K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+3K250622Succession™ AFN SystemOrtho Solutions UK, Ltd.20250—
+3K250559GMReis Fibula Nail SystemGm Dos Reis Industria E Comercio20250—
+3K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+3K234128Phantom Fibula Nail SystemParagon 28, Inc.202401
+3K230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail…Tdm Co., Ltd.20240—
+3K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp.20232—
+3K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+3K221221Advanced Intramedullary Nail SystemDouble Medical Technology, Inc.20220—
+3K221031Arthrex DualCompression Hindfoot Fusion Nail Implant SystemArthrex, Inc.20220—
+3K210792Auxein Nailing SystemAuxein Medical Private Limited20210—
+3K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+3K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+3K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+3K191598AOS ES Retrograde Femoral NailAdvanced Orthopaedic Solutions, Inc.20190—
+3K182677DynaNail MiniMedShape, Inc.20195—
+3K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+3K181639Panta 2 Arthrodesis Nail SystemIntegra LifeSciences Corporation20180—
+3K172830Double Medical Femoral Nail SystemDouble Medical Technology, Inc.20182—
+3K173656Arthrex FibuLock NailArthrex, Inc.20183—
+3K172583OrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc.201843
+3K172699Agile NailOrthofix Srl20180—
+3K173811TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis SystemIn2bones Sas20181—
+3K171376DynaNail TTC Fusion SystemMedShape, Inc.201722—
+3K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+3K161371Sonoma Fifth Metatarsal Repair SystemSonoma Orthopedic Products, Inc.20170—
+3K160545Gap Endo-Exo Medullary SystemPega Medical, Inc.20166—
+3K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC20160—
+3K150471CalcaNail Orthopedic Arthrodesis NailFournitures Hospitalieres Industrie20150—
+3K150463CalcaNail Orthopedic NailFournitures Hospitalieres Industrie20150—
+3K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+3K133081Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…Advanced Orthopaedic Solutions, Inc.20132—
+3K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+3K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc.201201
+3K102577Force Medical IM Nail SystemForce Medical, Inc.20120—
+3K081356Olecranail Intramedullary Fixation SystemMylad Orthopedic Solutions, LLC20082—
+4K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—
+4K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+4K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.20260—
+4K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+4K250197Estremo Fibular NailCitieffe S.R.L.20250—
+4K250628DynaNail TTC Fusion SystemMedShape, Inc.20250—
+4K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+4K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+4K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.20251—
+4K242356TIDAL Fusion Cage SystemRestor3D, Inc.20250—
+4K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220—
+4K220679Pediatric Nailing Platform FemurOrthoPediatrics Corp.20222—
+4K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20211—
+4K203381Dynanail Mini HybridMedShape, Inc.202141
+4K200430Precice® Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc.20203—
+4K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—