510(k) Report

Devices descending from K965098

75 later devices reach Intramedullary Nail System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181827Affixus Natural Nail System Humeral NailZimmer GmbH20186—
+1K142281Zimmer M/DN Intramedullary Fixation SystemZimmer, Inc.2014107
+1K120715Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia ShortZimmer GmbH201210—
+1K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+1K091566Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH2009165
+1K090596Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis Fossa and…Zimmer, Inc.2009316
+1K083497Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral NailsZimmer, Inc.20093916
+1K082770Zimmer Natural Nail System Tibial NailZimmer, Inc.20083515
+1K032367Itst Intertrochanteric Subtrochanteric Intramedullary Femoral NailZimmer, Inc.20031712
+2K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+2K253749Affixus® Natural Nail® Proximal Humeral SystemZimmer Switzerland Manufacturing GmbH20250—
+2K243907Affixus Tibial Nailing System - 4mm screwsZimmer, Inc.20250—
+2K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc.2024217
+2K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail…Zimmer Switzerland Manufacturing GmbH20234—
+2K210285Adaptable Ortho Innovations Intramedullary Nail SystemAdaptable Ortho Innovations, LLC20210—
+2K200814Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH20201—
+2K192312Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH20194—
+2K191238Zimmer Guide Wire DevicesZimmer, Inc.20190—
+2K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics20181—
+2K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH201816—
+2K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH201817—
+2K171108AUTOBAHN Nailing SystemGlobus Medical, Inc.20172—
+2K170972Apex Tibial Nailing SystemOrthoxel20171—
+2K172114Zimmer Natural Nail SystemZimmer, Inc.201711—
+2K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+2K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+2K143321ITST Intertrochanteric/Subtrochanteric Fixation SystemZimmer, Inc.201502
+2K140601Flow-NailFlow-Fx, LLC20142—
+2K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+2K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+2K130595Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial NailZimmer, Inc.201323
+2K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+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—
+3K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc.20260—
+3K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230—
+3K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc.20221—
+3K221115Flow-NailFlow-Fx, LLC20221—
+3K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+3K200869Gamma3 SystemStryker Trauma GmbH20209—
+3K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH201915—
+3K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+3K181184OIC Intramedullary Nail SystemThe Orthopaedic Implant Company20181—
+3K181375Apex Femoral Nailing SystemOrthoxel20180—
+3K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+3K163589SIGN IM NailSign Fracture Care International20170—
+3K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+3K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+4K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+4K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+4K242247ARIX Femur Nail SystemJeil Medical Corporation20251—
+4K233134I.T.S. INS Proximal Femur NailI.T.S. GmbH20240—
+4K234075Flow-NailFlow-Fx, LLC20240—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+4K230512Gamma4 SystemStryker GmbH20230—
+4K223761OIC Intramedullary Screw SystemOrthopaedic Implant Company20230—
+4K221021Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A20220—
+4K222309Gamma4 SystemStryker GmbH20220—
+4K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH20217—
+4K193308T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH20204—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+4K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+4K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+5K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+5K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+5K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+5K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+5K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—
+6K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+6K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+6K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+7K261481Pangea Femur Reconstruction SystemStryker GmbH20260—