510(k) Report

Devices descending from K932330

116 later devices reach TI-6AL-7NB Urtn through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes20182—
+1K133166Ins Hilden Tibial ArzztTruemed Group, LLC20141—
+1K043270Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631, 02.02651, 02.02652…Zimmer GmbH2005532
+1K990717Fixion Intramedullary Nailing SystemDisco-O-Tech Medical Technologies, Ltd.199956—
+2K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.20260—
+2K201830ANSER Clavicle PinBAAT Medical Products B.V.20200—
+2K172189Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt &…Truemed Group, LLC20180—
+2K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+2K090596Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis Fossa and…Zimmer, Inc.2009316
+2K083497Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral NailsZimmer, Inc.20093916
+2K082770Zimmer Natural Nail System Tibial NailZimmer, Inc.20083515
+2K080706Connexx Locking Tibia NailI.T.S. Implantat-Technologie-Systeme GmbH200811—
+2K071679Metafix and Fixion FA Intramedullary Nailing SystemsDisc-O-Tech Medical Technologies, Ltd.20070—
+2K032588Modification to Fixion Intramedullary Nailing System (Fixion IM)Disco-O-Tech Medical Technologies, Ltd.200332—
+2K023437Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing…Disco-O-Tech Medical Technologies, Ltd.200253—
+2K021324Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd.2002541
+2K013449Modification to Fixion Interlocking Intramedullary Nailing SystemDisc-O-Tech Medical Technologies, Ltd.200154—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+3K243907Affixus Tibial Nailing System - 4mm screwsZimmer, Inc.20250—
+3K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc.2024217
+3K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics20181—
+3K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH201816—
+3K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH201817—
+3K171108AUTOBAHN Nailing SystemGlobus Medical, Inc.20172—
+3K170972Apex Tibial Nailing SystemOrthoxel20171—
+3K172114Zimmer Natural Nail SystemZimmer, Inc.201711—
+3K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+3K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+3K130595Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial NailZimmer, Inc.201323
+3K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+3K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+3K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.201031—
+3K091566Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH2009165
+3K032730Fixion Hip SystemDisc-O-Tech Medical Technologies, Ltd.20040—
+3K032358B-Twin Bone Expander System (B-Twin BE System)Disc-O-Tech Medical Technologies, Ltd.200316—
+3K031401Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd.200332—
+4K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.20260—
+4K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc.20260—
+4K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail…Zimmer Switzerland Manufacturing GmbH20234—
+4K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+4K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230—
+4K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc.20221—
+4K200869Gamma3 SystemStryker Trauma GmbH20209—
+4K192312Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH20194—
+4K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH201915—
+4K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+4K181184OIC Intramedullary Nail SystemThe Orthopaedic Implant Company20181—
+4K181375Apex Femoral Nailing SystemOrthoxel20180—
+4K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+4K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+4K140601Flow-NailFlow-Fx, LLC20142—
+4K131636Polarus ConnectAcumed, LLC20130—
+4K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+4K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+4K120715Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia ShortZimmer GmbH201210—
+4K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+4K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+4K040612Sky Bone Expander System (Sky System)Disc-O-Tech Medical Technologies, Ltd.200413—
+4K034037Sky Bone Expander SystemDisc-O-Tech Medical Technologies, Ltd.200415—
+5K253749Affixus® Natural Nail® Proximal Humeral SystemZimmer Switzerland Manufacturing GmbH20250—
+5K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+5K242247ARIX Femur Nail SystemJeil Medical Corporation20251—
+5K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+5K233134I.T.S. INS Proximal Femur NailI.T.S. GmbH20240—
+5K223761OIC Intramedullary Screw SystemOrthopaedic Implant Company20230—
+5K221021Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A20220—
+5K221115Flow-NailFlow-Fx, LLC20221—
+5K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+5K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH20217—
+5K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+5K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+5K193308T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH20204—
+5K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+5K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+5K163589SIGN IM NailSign Fracture Care International20170—
+5K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+5K160995NEOVIEW Plating SystemIn2bones Sas201624
+5K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+5K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+5K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+5K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+5K053336Staxx FX SystemSpine Wave, Inc.200612—
+5K040939Sky Bone Expander System (Sky System)Disc-O-Tech Medical Technologies, Ltd.20040—
+6K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K234075Flow-NailFlow-Fx, LLC20240—
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K230512Gamma4 SystemStryker GmbH20230—
+6K222309Gamma4 SystemStryker GmbH20220—
+6K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+6K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+6K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+6K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+6K080108Cortoss Bone Augmentation MaterialOrthovita, Inc.200904
+6K063606Modification to Staxx FX SystemSpine Wave, Inc.200711—
+7K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+7K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—