510(k) Report

Devices descending from K954555

76 later devices reach Versa-FX Femoral Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150818Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral…Zimmer, Inc.201526
+1K983814Gotfried Percutaneous Compression Plating SystemEfratgo, Ltd. HI Tech Bio-Surgical199971—
+1K970280Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Per-Trochanteroam…Ferguson Medical19970—
+2K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+2K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc.200835—
+2K043233Gotfried Physiological Hip (PH) NailEfratgo, Ltd. HI Tech Bio-Surgical20051—
+2K031401Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd.200332—
+3K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+3K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+3K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+3K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+3K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+3K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.201031—
+3K090656Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc.200934—
+3K083648Gotfried Physiological Hip (PH) NailEfratgo, Ltd. HI Tech Bio-Surgical20090—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+4K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+4K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+4K160995NEOVIEW Plating SystemIn2bones Sas201624
+4K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+4K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+4K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+4K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+4K131636Polarus ConnectAcumed, LLC20130—
+4K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+4K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+4K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+4K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+4K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+4K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+5K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+5K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+5K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+5K240487EVOS Patella PlatesSmith & Nephew20240—
+5K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+5K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+5K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+5K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+5K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+5K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+5K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+6K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+6K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+6K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+6K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+6K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+6K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+6K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+6K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+6K173746Activmotion RangeNewclip Technics20181—
+6K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+6K163589SIGN IM NailSign Fracture Care International20170—
+7K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+7K241539Activmotion SNewclip Technics20240—
+7K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+7K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+7K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+7K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+8K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+8K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+8K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+8K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+9K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+9K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+9K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+9K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123