510(k) Report

Devices descending from K034002

69 later devices reach GAMMA3 Nail System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201147Elos® Intramedullary Nailing SystemIntrauma S.P.A20210—
+1K200869Gamma3 SystemStryker Trauma GmbH20209—
+1K150769Cardinal Health Trochanteric IM Nail SystemCardinalhealth20150—
+1K111352Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc.20111—
+1K102992T2 Recon Nail, R1500, Left/Right 125 Degrees / 120 Degrees / 130 DegreesHowmedica Osteonics Corp.201037—
+1K043431GAMMA3 Nail SystemHowmedica Osteonics Corp.200548—
+1K043233Gotfried Physiological Hip (PH) NailEfratgo, Ltd. HI Tech Bio-Surgical20051—
+2K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.20260—
+2K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+2K242247ARIX Femur Nail SystemJeil Medical Corporation20251—
+2K233134I.T.S. INS Proximal Femur NailI.T.S. GmbH20240—
+2K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc.20230—
+2K221021Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A20220—
+2K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+2K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+2K203811GPC Intraheal Intramedullary Nailing SystemGpc Medical Limited20220—
+2K211086The Progen™ Trochanteric Nail SystemOrtho Development Corporation20210—
+2K201379Artemis Proximal Femoral Nail SystemGlw, Inc.20211—
+2K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon…Stryker GmbH202011—
+2K172830Double Medical Femoral Nail SystemDouble Medical Technology, Inc.20182—
+2K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH201817—
+2K171108AUTOBAHN Nailing SystemGlobus Medical, Inc.20172—
+2K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+2K161466ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing SystemOrthofix Srl20171—
+2K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+2K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+2K150655OIC Intramedullary Nail SystemOrthopaedic Implant Company20152—
+2K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+2K123401GAMMA3 and T2 Recon Targeting DevicesStryker Trauma AG2013201
+2K113409S2 Femoral a/R Nail S2 Femoral Comression Nail S2 Tibial Nail S2 Tibial Compression NailHowmedica Osteonics Corp.20120—
+2K100238HFN 125 Degree 9-13 MM, 180MM, HFN 130 Degree 9-13 MM, HFN RH 125 Degree 9-13MMDePuy Orthopaedics, Inc.20107250
+2K083648Gotfried Physiological Hip (PH) NailEfratgo, Ltd. HI Tech Bio-Surgical20090—
+3K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.20260—
+3K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.20260—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+3K230088Ankle Truss System (ATS)4Web Medical, Inc.20241—
+3K230512Gamma4 SystemStryker GmbH20230—
+3K222309Gamma4 SystemStryker GmbH20220—
+3K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc.20221—
+3K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH20217—
+3K192003Auxein Nailing SystemAuxein Medical Private Limited20202—
+3K183162Affixus Hip Fracture NailBiomet, Inc.20182—
+3K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+3K181184OIC Intramedullary Nail SystemThe Orthopaedic Implant Company20181—
+3K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH201816—
+3K170972Apex Tibial Nailing SystemOrthoxel20171—
+3K173458ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing SystemOrthofix Srl20170—
+3K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+3K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+3K111444Universal and Troch Entry Femoral Nailing Systems Line ExtensionDePuy Orthopaedics, Inc.20110—
+4K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+4K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+4K242356TIDAL Fusion Cage SystemRestor3D, Inc.20250—
+4K230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail…Tdm Co., Ltd.20240—
+4K233910Vertex Hip Fracture Nailing SystemOrthoxel Dac20240—
+4K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+4K223761OIC Intramedullary Screw SystemOrthopaedic Implant Company20230—
+4K210792Auxein Nailing SystemAuxein Medical Private Limited20210—
+4K202749ADAPT for Gamma3Stryker GmbH20200—
+4K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH201915—
+4K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+5K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+5K193308T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH20204—
+5K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—