510(k) Report

Devices descending from K970097

184 later devices reach Proximal Femoral Nail (PFN) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+5K191598AOS ES Retrograde Femoral NailAdvanced Orthopaedic Solutions, Inc.20190—
+5K191238Zimmer Guide Wire DevicesZimmer, Inc.20190—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K183162Affixus Hip Fracture NailBiomet, Inc.20182—
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics20181—
+5K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+5K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH201817—
+5K171108AUTOBAHN Nailing SystemGlobus Medical, Inc.20172—
+5K172114Zimmer Natural Nail SystemZimmer, Inc.201711—
+5K163589SIGN IM NailSign Fracture Care International20170—
+5K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+5K142281Zimmer M/DN Intramedullary Fixation SystemZimmer, Inc.2014107
+5K130595Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial NailZimmer, Inc.201323
+5K091566Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH2009165
+5K080108Cortoss Bone Augmentation MaterialOrthovita, Inc.200904
+5K063606Modification to Staxx FX SystemSpine Wave, Inc.200711—
+6K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+6K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+6K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.20260—
+6K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K243907Affixus Tibial Nailing System - 4mm screwsZimmer, Inc.20250—
+6K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+6K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+6K233910Vertex Hip Fracture Nailing SystemOrthoxel Dac20240—
+6K234075Flow-NailFlow-Fx, LLC20240—
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail…Zimmer Switzerland Manufacturing GmbH20234—
+6K230512Gamma4 SystemStryker GmbH20230—
+6K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230—
+6K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+6K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+6K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc.20221—
+6K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+6K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K210285Adaptable Ortho Innovations Intramedullary Nail SystemAdaptable Ortho Innovations, LLC20210—
+6K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+6K200869Gamma3 SystemStryker Trauma GmbH20209—
+6K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+6K192312Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH20194—
+6K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+6K181827Affixus Natural Nail System Humeral NailZimmer GmbH20186—
+6K181184OIC Intramedullary Nail SystemThe Orthopaedic Implant Company20181—
+6K181375Apex Femoral Nailing SystemOrthoxel20180—
+6K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH201816—
+6K173746Activmotion RangeNewclip Technics20181—
+6K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+6K143321ITST Intertrochanteric/Subtrochanteric Fixation SystemZimmer, Inc.201502
+6K132817Kiva VCF Treatment SystemBenvenue Medical, Inc.20149—
+6K120715Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia ShortZimmer GmbH201210—
+7K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+7K253749Affixus® Natural Nail® Proximal Humeral SystemZimmer Switzerland Manufacturing GmbH20250—
+7K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+7K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+7K242247ARIX Femur Nail SystemJeil Medical Corporation20251—
+7K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+7K241539Activmotion SNewclip Technics20240—
+7K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+7K233134I.T.S. INS Proximal Femur NailI.T.S. GmbH20240—
+7K223761OIC Intramedullary Screw SystemOrthopaedic Implant Company20230—
+7K221021Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A20220—
+7K222309Gamma4 SystemStryker GmbH20220—
+7K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+7K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K200814Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH20201—
+7K191709V-STRUT Vertebral ImplantHyprevention Sas20202—
+7K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH201915—
+7K181262SpineJack Expansion KitVexim SA20184—
+7K141141Kiva VCF Treatment SystemBenvenue Medical, Inc.20140—
+8K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+8K240084V-STRUT® Vertebral ImplantHyprevention20240—
+8K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+8K221697Injection Pin (Kip (02031-02061) (03031-03061))Slk Ortho, LLC20230—
+8K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+8K202393SpineJack Expansion KitStryker Corporation20203—
+8K193308T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH20204—
+9K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+9K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+9K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+10K223294SpineJack® Expansion KitStryker Instruments20221—
+11K250637VCFix Spinal SystemAmber Implants20250—