510(k) Report

Devices descending from K090675

487 later devices reach Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+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
+1K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+1K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+1K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+1K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+1K151407RECON systemNormed Medizin-Technik GmbH20154—
+1K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+1K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+1K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+1K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+1K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+1K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+1K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+1K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+1K124027Monster Screw SystemApogee Orthosolutions201341—
+1K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+1K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+1K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+1K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+1K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+1K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+2K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+2K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+2K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+2K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+2K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+2K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+2K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+2K240487EVOS Patella PlatesSmith & Nephew20240—
+2K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+2K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+2K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+2K233017TM Plating SystemTyber Medical, LLC20231—
+2K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+2K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+2K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+2K221342REDEMPTION Beaming SystemVilex, LLC20220—
+2K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+2K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+2K202326BESPA Charcot SystemBespa Global, LLC20210—
+2K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+2K210953SMART Taylor Spatial FrameSmith & Nephew, Inc.20212—
+2K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+2K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+2K200062Foot and Ankle SystemLeith Medical, LLC20210—
+2K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+2K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+2K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+2K193368Smart Correction SystemWishbone Medical, Inc.202031
+2K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+2K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+2K193029Conquest FNSmith & Nephew, Inc.202010—
+2K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+2K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+2K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+2K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+2K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+2K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+2K190586Monster® Screw SystemParagon 28, Inc.201921—
+2K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+2K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+2K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+2K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+2K172785Conquest FNSmith & Nephew20178—
+2K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+2K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+2K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+2K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+2K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+2K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+2K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+2K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+2K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC20168—
+2K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+2K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+2K152686Conquest FNSmith & Nephew201612—
+2K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+2K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+2K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+2K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K151418Monster Screw SystemParagon 28201527—
+2K142581APTUS Foot SystemMedartis AG201522—
+2K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+2K143365Eminent Foot Plate SystemEminent Spine20151—
+2K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+2K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+2K142520Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based softwareSmith & Nephew, Inc.201431
+2K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+2K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+2K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl201432—
+2K140550Orthohub External Fixator SoftwareOrthohub, Inc.20145—
+2K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+2K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—