510(k) Report

Devices descending from K003212

56 later devices reach Fixion Intramedullary Nailing System (Fixion IM Nail) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032588Modification to Fixion Intramedullary Nailing System (Fixion IM)Disco-O-Tech Medical Technologies, Ltd.200332—
+1K023437Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing…Disco-O-Tech Medical Technologies, Ltd.200253—
+1K021324Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd.2002541
+1K013449Modification to Fixion Interlocking Intramedullary Nailing SystemDisc-O-Tech Medical Technologies, Ltd.200154—
+2K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+2K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+2K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.201031—
+2K071679Metafix and Fixion FA Intramedullary Nailing SystemsDisc-O-Tech Medical Technologies, Ltd.20070—
+2K032730Fixion Hip SystemDisc-O-Tech Medical Technologies, Ltd.20040—
+2K032358B-Twin Bone Expander System (B-Twin BE System)Disc-O-Tech Medical Technologies, Ltd.200316—
+2K031401Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd.200332—
+3K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+3K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+3K131636Polarus ConnectAcumed, LLC20130—
+3K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+3K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+3K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+3K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+3K040612Sky Bone Expander System (Sky System)Disc-O-Tech Medical Technologies, Ltd.200413—
+3K034037Sky Bone Expander SystemDisc-O-Tech Medical Technologies, Ltd.200415—
+4K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+4K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+4K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+4K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+4K163589SIGN IM NailSign Fracture Care International20170—
+4K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+4K160995NEOVIEW Plating SystemIn2bones Sas201624
+4K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+4K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+4K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+4K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+4K053336Staxx FX SystemSpine Wave, Inc.200612—
+4K040939Sky Bone Expander System (Sky System)Disc-O-Tech Medical Technologies, Ltd.20040—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+5K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+5K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+5K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+5K080108Cortoss Bone Augmentation MaterialOrthovita, Inc.200904
+5K063606Modification to Staxx FX SystemSpine Wave, Inc.200711—
+6K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+6K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+6K132817Kiva VCF Treatment SystemBenvenue Medical, Inc.20149—
+7K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+7K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+7K191709V-STRUT Vertebral ImplantHyprevention Sas20202—
+7K181262SpineJack Expansion KitVexim SA20184—
+7K141141Kiva VCF Treatment SystemBenvenue Medical, Inc.20140—
+8K240084V-STRUT® Vertebral ImplantHyprevention20240—
+8K221697Injection Pin (Kip (02031-02061) (03031-03061))Slk Ortho, LLC20230—
+8K202393SpineJack Expansion KitStryker Corporation20203—
+9K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+10K223294SpineJack® Expansion KitStryker Instruments20221—
+11K250637VCFix Spinal SystemAmber Implants20250—