510(k) Report

Devices descending from K962823

836 later devices reach Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+1K170021SMV Scientific Cannulated ScrewsSmv Scientific20178—
+1K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+1K142776Flow-ScrewFlow-Fx, LLC20151—
+1K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+1K1431883.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp201481
+1K124027Monster Screw SystemApogee Orthosolutions201341—
+1K112240Dyna Locking Cannulated ScrewU&I Corp.201214—
+1K102343Emerge Medical Cannulated Screw Fixation SystemEmerge Medical2010220—
+1K101700IO Fix Hand, IO Fix Foot, Extremity Medical Screw SystemExtremity Medical, LLC2010562
+1K093770Extremity Medical Screw SystemExtremity Medical, LLC20103—
+1K092440Ascension Cannulated Screw SystemAscension Orthopedics, Inc.20090—
+1K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+1K082874Biodrive Cannulated Screw SystemBiomet Trauma2009168—
+1K082949Orthopediatrics Bone ScrewsOrthoPediatrics Corp.200811—
+1K071092Asnis Micro Cannulated ScrewHowmedica Osteonics Corp.200738—
+1K022952Modular Head Bone ScrewBiomet, Inc.20020—
+1K013534Self-Countersinking Bone ScrewBiomet Orthopedics, Inc.2001241—
+1K011821Modification to the I.C.O.S ScrewNew Deal, S.A.200156—
+1K993762I.CO.S ScrewNew Deal, S.A.2000338—
+2K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+2K221342REDEMPTION Beaming SystemVilex, LLC20220—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+2K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+2K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+2K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+2K200291CREED™ Cannulated ScrewsGlw Medical, Inc.20202—
+2K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+2K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+2K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+2K200259Headless Compression Screw SystemOsteocentric Extremities, LLC20200—
+2K190586Monster® Screw SystemParagon 28, Inc.201921—
+2K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+2K173556Injection ScrewBiedermann Medtech, Inc.20180—
+2K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+2K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+2K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+2K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K170594I.B.S. osteosynthesis screwsIn2bones Sas20171—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+2K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201613—
+2K151407RECON systemNormed Medizin-Technik GmbH20154—
+2K151418Monster Screw SystemParagon 28201527—
+2K142581APTUS Foot SystemMedartis AG201522—
+2K141401Easy OutFeet For Life Podiatry Center20150—
+2K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+2K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+2K140891Biomet Cannulated Screw SystemBiomet, Inc.2014165
+2K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+2K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+2K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+2K140018TSP Hip Fracture Plating SystemBiomet, Inc.201412
+2K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+2K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+2K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+2K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+2K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+2K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+2K130590Aap Cannulated Screw 2.0Aap Implantate AG20130—
+2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+2K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+2K121417XMCP, Hallux, Tarsx, Extremity Medical Screw SystemExtremity Medical, LLC20122—
+2K121349IO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and WasherExtremity Medical, LLC201212—
+2K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+2K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+2K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+2K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+2K110658Aptus Cannulated Compression ScrewsMedartis AG201112—
+2K103705Low Profile ScrewsArthrex, Inc.2011219—
+2K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+2K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+2K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine20101431
+2K092670Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma200968—
+2K082574Maxtorque Mini Cannulated Screw SystemOrthohelix Surgical Designs, Inc.200833
+2K080649Pogo ScrewFxdevices200815—
+2K081934Extremity Medical Compression ScrewExtremity Medical, LLC200868—
+2K050346Stabilization ScrewNew Deal, S.A.2005554
+2K024233Kompressor Screw SystemKinetikos Medical, Inc.2003299—
+2K024086Propeller Head Small Cannulated Screw SystemBiomet Orthopedics, Inc.2003171—
+3K254280F.A.S.T ScrewSteps Ortho20260—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+3K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+3K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+3K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+3K240487EVOS Patella PlatesSmith & Nephew20240—