510(k) Report

Devices descending from K993289

182 later devices reach Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+1K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+1K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+1K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics20181—
+1K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+1K112406Peri-Loc Proximal Femur Locking Bone PlatesSmith & Nephew, Inc.20113—
+1K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+1K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc.200835—
+1K072818Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe AccessSmith & Nephew, Inc.200793—
+1K050849HA Coated Lag ScrewSmith & Nephew, Inc.200534—
+1K050226Asian Intramedullary Hip Screw NailsSmith & Nephew, Inc.20057—
+1K040656Modification to Smith & Nephew Intramedullary Hip ScrewSmith & Nephew, Inc.20049—
+1K040212Trigen IntertanSmith & Nephew, Inc.20041216
+2K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+2K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+2K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+2K240061TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemSmith & Nephew, Inc.20240—
+2K241804TRIGEN INTERTAN 10S Nail SystemSmith & Nephew, Inc.20240—
+2K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+2K233910Vertex Hip Fracture Nailing SystemOrthoxel Dac20240—
+2K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+2K233017TM Plating SystemTyber Medical, LLC20231—
+2K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230—
+2K210980Smith & Nephew Intramedullary Nail SystemsSmith & Nephew, Inc.202204
+2K211086The Progen™ Trochanteric Nail SystemOrtho Development Corporation20210—
+2K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+2K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+2K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+2K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+2K200869Gamma3 SystemStryker Trauma GmbH20209—
+2K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+2K182154Depuy Synthes Femoral Neck SystemSynthes (USA) Products, LLC20181—
+2K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+2K123948China Nails and AccessoriesSmith & Nephew, Inc.20130—
+2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+2K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc.201201
+2K120083Set Screw for TI Trochanteric Fixation Nail (TFN)Synthes USA20123—
+2K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc.201038—
+2K092748Sureshot Tan Nails and AccessoriesSmith & Nephew, Inc.201041
+2K090656Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc.200934—
+2K083648Gotfried Physiological Hip (PH) NailEfratgo, Ltd. HI Tech Bio-Surgical20090—
+2K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.2009772
+2K070761Sanatmetal Nails and PinsSanatmetal Mfr. of Orthopaedic/Traumatologic Prod.20083—
+2K051557Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc.200569—
+3K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+3K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.20260—
+3K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+3K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+3K242247ARIX Femur Nail SystemJeil Medical Corporation20251—
+3K243364TRIGEN META-TAN Trochanteric Antegrade NailSmith & Nephew, Inc.20241—
+3K233134I.T.S. INS Proximal Femur NailI.T.S. GmbH20240—
+3K230761TRIGEN META-NAIL Nail SystemSmith & Nephew, Inc.20232—
+3K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+3K221021Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A20220—
+3K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+3K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+3K192003Auxein Nailing SystemAuxein Medical Private Limited20202—
+3K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes20182—
+3K172830Double Medical Femoral Nail SystemDouble Medical Technology, Inc.20182—
+3K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+3K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc.201713—
+3K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+3K161665VLP Wrist Fracture SystemSmith & Nephew, Inc.201610—
+3K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+3K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+3K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426—
+3K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+3K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+3K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+3K132296D-Rad Smart PackSmith & Nephew, Inc.2014114
+3K132830Distalock Tibial IM Nail SystemDgimed Ortho, Inc.20140—
+3K061019Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc.2006601
+4K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.20260—
+4K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.20260—
+4K253517Reselute Tibial NailReselute, Inc.20260—
+4K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+4K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+4K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+4K243608TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc.20250—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail…Tdm Co., Ltd.20240—
+4K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+4K230512Gamma4 SystemStryker GmbH20230—
+4K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+4K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+4K222309Gamma4 SystemStryker GmbH20220—
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K210792Auxein Nailing SystemAuxein Medical Private Limited20210—
+4K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K201830ANSER Clavicle PinBAAT Medical Products B.V.20200—
+4K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—