510(k) Report

Devices descending from K970097

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192003Auxein Nailing SystemAuxein Medical Private Limited20202—
+1K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes20182—
+1K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+1K043233Gotfried Physiological Hip (PH) NailEfratgo, Ltd. HI Tech Bio-Surgical20051—
+1K021782BNFAap Implantate AG20020—
+1K010988Fixion Interlocking Proximal Femoral Nailing SystemDisc-O-Tech Medical Technologies, Ltd.2001591
+1K983814Gotfried Percutaneous Compression Plating SystemEfratgo, Ltd. HI Tech Bio-Surgical199971—
+1K973240Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa)199773—
+2K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.20260—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail…Tdm Co., Ltd.20240—
+2K210792Auxein Nailing SystemAuxein Medical Private Limited20210—
+2K201830ANSER Clavicle PinBAAT Medical Products B.V.20200—
+2K170972Apex Tibial Nailing SystemOrthoxel20171—
+2K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+2K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+2K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+2K133104Van Hip Fracture SystemEpix Orthopaedic, Corp.20140—
+2K093707Dyna Locking Trochanteric Nail, Model NG0820U&I Corp.20101—
+2K093089Magnum NailRobert Reid, Inc.20090—
+2K083648Gotfried Physiological Hip (PH) NailEfratgo, Ltd. HI Tech Bio-Surgical20090—
+2K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc.200835—
+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—
+2K032588Modification to Fixion Intramedullary Nailing System (Fixion IM)Disco-O-Tech Medical Technologies, Ltd.200332—
+2K031401Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd.200332—
+2K030972Fixion Unipolar Modular Hemi-Hip System (Fixion MH)Disc-O-Tech Medical Technologies, Ltd.20031—
+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
+2K013563Long Trochanteric Nail SystemDePuy Orthopaedics, Inc.20017054
+2K012967Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing SystemDisco-O-Tech Medical Technologies, Ltd.2001561
+3K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+3K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+3K221084Dyna Locking Trochanteric Nail™Innosys20230—
+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
+3K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+3K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+3K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+3K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+3K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+3K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+3K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+3K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.201031—
+3K090656Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc.200934—
+3K042325Trochanteric Nail SystemDePuy Orthopaedics, Inc.20041011
+3K040612Sky Bone Expander System (Sky System)Disc-O-Tech Medical Technologies, Ltd.200413—
+3K034037Sky Bone Expander SystemDisc-O-Tech Medical Technologies, Ltd.200415—
+3K033329Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc.200353—
+3K021008Advanced Orthopaedic Solutions Trochanteric NailAdvanced Orthopaedic Solutions, Inc.20021312
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+4K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+4K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+4K202099AOS Galileo™ Trochanteric Nail SystemAdvanced Orthopaedic Solutions, Inc.20204—
+4K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—
+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—
+4K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+4K140601Flow-NailFlow-Fx, LLC20142—
+4K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+4K133081Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…Advanced Orthopaedic Solutions, Inc.20132—
+4K131636Polarus ConnectAcumed, LLC20130—
+4K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+4K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+4K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+4K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+4K120148Aos Solid Locking Lag Screw, Aos Telescoping Lag ScrewAdvanced Orthopaedic Solutions, Inc.20126—
+4K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+4K111444Universal and Troch Entry Femoral Nailing Systems Line ExtensionDePuy Orthopaedics, Inc.20110—
+4K103533ES Trochanteric Nail, Left and Right, 10MMAdvanced Orthopaedic Solutions, Inc.201111—
+4K101622Zimmer Natural Nail System Retrograde Femoral NailsZimmer, Inc.2010293
+4K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+4K100238HFN 125 Degree 9-13 MM, 180MM, HFN 130 Degree 9-13 MM, HFN RH 125 Degree 9-13MMDePuy Orthopaedics, Inc.20107250
+4K090596Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis Fossa and…Zimmer, Inc.2009316
+4K083497Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral NailsZimmer, Inc.20093916
+4K053336Staxx FX SystemSpine Wave, Inc.200612—
+4K042440Alphatec Femoral Trochanteric Nail (FTN) SystemAlphatec/Nexmed20040—
+4K040939Sky Bone Expander System (Sky System)Disc-O-Tech Medical Technologies, Ltd.20040—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc.20260—
+5K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+5K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+5K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+5K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+5K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+5K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+5K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc.2024217
+5K240487EVOS Patella PlatesSmith & Nephew20240—
+5K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+5K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+5K221115Flow-NailFlow-Fx, LLC20221—
+5K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH20217—