510(k) Report

Devices descending from K060736

531 later devices reach Smith & Nephew 6.5MM and 8.0MM Cannulated Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+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
+1K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+1K124027Monster Screw SystemApogee Orthosolutions201341—
+1K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+1K093676Omnitech Large, Trimed Compression ScrewTriMed, Inc.201013—
+1K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+1K080649Pogo ScrewFxdevices200815—
+1K072818Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe AccessSmith & Nephew, Inc.200793—
+2K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+2K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+2K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+2K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+2K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+2K233017TM Plating SystemTyber Medical, LLC20231—
+2K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+2K221342REDEMPTION Beaming SystemVilex, LLC20220—
+2K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+2K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+2K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+2K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+2K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+2K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+2K190586Monster® Screw SystemParagon 28, Inc.201921—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+2K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics20181—
+2K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+2K172785Conquest FNSmith & Nephew20178—
+2K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+2K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+2K152686Conquest FNSmith & Nephew201612—
+2K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+2K151407RECON systemNormed Medizin-Technik GmbH20154—
+2K151418Monster Screw SystemParagon 28201527—
+2K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+2K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+2K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+2K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+2K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+2K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+2K131591Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe)Pega Medical, Inc.201302
+2K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+2K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+2K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+2K112794Eos Small Bone Fixation SystemTriMed, Inc.201294
+2K112406Peri-Loc Proximal Femur Locking Bone PlatesSmith & Nephew, Inc.20113—
+2K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+2K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+2K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+2K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+2K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc.201038—
+2K092189Pogo ScrewFxdevices20091—
+2K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.2009772
+2K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc.200835—
+3K262344Large Compression ScrewsTriMed, Inc.20260—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+3K261241TriMed Compression ScrewsTriMed, Inc.20260—
+3K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+3K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+3K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+3K240487EVOS Patella PlatesSmith & Nephew20240—
+3K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+3K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+3K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+3K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+3K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+3K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+3K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+3K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230—
+3K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+3K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+3K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+3K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+3K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+3K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+3K202326BESPA Charcot SystemBespa Global, LLC20210—
+3K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+3K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+3K210953SMART Taylor Spatial FrameSmith & Nephew, Inc.20212—
+3K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+3K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+3K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+3K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+3K200062Foot and Ankle SystemLeith Medical, LLC20210—
+3K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+3K203011Monster Screw SystemParagon 28, Inc.20206—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+3K193368Smart Correction SystemWishbone Medical, Inc.202031
+3K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+3K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+3K193029Conquest FNSmith & Nephew, Inc.202010—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—