510(k) Report

Devices descending from K010988

59 later devices reach Fixion Interlocking Proximal Femoral Nailing System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+1K133104Van Hip Fracture SystemEpix Orthopaedic, Corp.20140—
+1K093089Magnum NailRobert Reid, Inc.20090—
+1K071679Metafix and Fixion FA Intramedullary Nailing SystemsDisc-O-Tech Medical Technologies, Ltd.20070—
+1K032730Fixion Hip SystemDisc-O-Tech Medical Technologies, Ltd.20040—
+1K032358B-Twin Bone Expander System (B-Twin BE System)Disc-O-Tech Medical Technologies, Ltd.200316—
+1K032588Modification to Fixion Intramedullary Nailing System (Fixion IM)Disco-O-Tech Medical Technologies, Ltd.200332—
+1K031401Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd.200332—
+1K030972Fixion Unipolar Modular Hemi-Hip System (Fixion MH)Disc-O-Tech Medical Technologies, Ltd.20031—
+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
+1K012967Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing SystemDisco-O-Tech Medical Technologies, Ltd.2001561
+2K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+2K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+2K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+2K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+2K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+2K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.201031—
+2K040612Sky Bone Expander System (Sky System)Disc-O-Tech Medical Technologies, Ltd.200413—
+2K034037Sky Bone Expander SystemDisc-O-Tech Medical Technologies, Ltd.200415—
+3K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+3K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+3K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+3K160995NEOVIEW Plating SystemIn2bones Sas201624
+3K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+3K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+3K131636Polarus ConnectAcumed, LLC20130—
+3K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+3K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+3K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+3K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+3K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+3K053336Staxx FX SystemSpine Wave, Inc.200612—
+3K040939Sky Bone Expander System (Sky System)Disc-O-Tech Medical Technologies, Ltd.20040—
+4K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+4K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+4K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+4K163589SIGN IM NailSign Fracture Care International20170—
+4K080108Cortoss Bone Augmentation MaterialOrthovita, Inc.200904
+4K063606Modification to Staxx FX SystemSpine Wave, Inc.200711—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+5K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+5K132817Kiva VCF Treatment SystemBenvenue Medical, Inc.20149—
+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—
+6K191709V-STRUT Vertebral ImplantHyprevention Sas20202—
+6K181262SpineJack Expansion KitVexim SA20184—
+6K141141Kiva VCF Treatment SystemBenvenue Medical, Inc.20140—
+7K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+7K240084V-STRUT® Vertebral ImplantHyprevention20240—
+7K221697Injection Pin (Kip (02031-02061) (03031-03061))Slk Ortho, LLC20230—
+7K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+7K202393SpineJack Expansion KitStryker Corporation20203—
+8K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+9K223294SpineJack® Expansion KitStryker Instruments20221—
+10K250637VCFix Spinal SystemAmber Implants20250—