510(k) Report

Devices descending from K012945

711 later devices reach Synthes 2.4 MM Cannulated Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170021SMV Scientific Cannulated ScrewsSmv Scientific20178—
+1K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+1K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+1K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+1K124027Monster Screw SystemApogee Orthosolutions201341—
+1K111008Microware Bone Plates and Bone ScrewMicroware Precision Co., Ltd.20120—
+1K102343Emerge Medical Cannulated Screw Fixation SystemEmerge Medical2010220—
+1K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+1K082874Biodrive Cannulated Screw SystemBiomet Trauma2009168—
+1K082949Orthopediatrics Bone ScrewsOrthoPediatrics Corp.200811—
+2K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+2K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+2K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+2K242988Genostis Osteosynthesis SystemGenostis AF20250—
+2K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+2K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+2K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+2K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+2K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+2K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+2K221342REDEMPTION Beaming SystemVilex, LLC20220—
+2K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+2K211435PAO Cortical ScrewMedacta International S.A.20210—
+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—
+2K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+2K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+2K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+2K200259Headless Compression Screw SystemOsteocentric Extremities, LLC20200—
+2K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+2K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+2K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+2K190830TDM Screw SystemsTdm Co., Ltd.20191—
+2K190586Monster® Screw SystemParagon 28, Inc.201921—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+2K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+2K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+2K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+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—
+2K151407RECON systemNormed Medizin-Technik GmbH20154—
+2K151418Monster Screw SystemParagon 28201527—
+2K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+2K1431883.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp201481
+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
+2K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+2K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+2K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+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
+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
+3K254280F.A.S.T ScrewSteps Ortho20260—
+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—
+3K261241TriMed Compression ScrewsTriMed, Inc.20260—
+3K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+3K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+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—
+3K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+3K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+3K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+3K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+3K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+3K231860TDM Screw SystemTdm Co., Ltd.20240—
+3K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402