510(k) Report

Devices descending from K012655

792 later devices reach Congruent Bone Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+3K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426—
+3K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+3K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+3K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+3K132502Variax 2 SystemStryker Trauma AG201321—
+3K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc.20131—
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+3K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation2013142
+3K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+3K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+3K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+3K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC201228—
+3K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+3K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+3K111266Easylock OsteosystemTriMed, Inc.20110—
+3K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc.20115—
+3K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+3K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+3K111326Osteowedge Opening Wedge Bone Locking SystemGraham Medical Technologies, LLC20111—
+3K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+3K103705Low Profile ScrewsArthrex, Inc.2011219—
+3K101930Memometal Navis Bone Plating SystemMemometal Technologies20110—
+3K102095Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20102—
+3K100176Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc.201056—
+3K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp.201013—
+3K093983Smple Plate and ScrewsBiomet Trauma (Aka Ebi, Lp)20100—
+3K092670Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma200968—
+3K091156Trimed Sterile ProductTriMed, Inc.20090—
+3K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+3K063820Lisfranc PlateNew Deal, S.A.20070—
+3K070241Modification to Lapidus PlateNew Deal, S.A.200701
+4K262649Alians ForearmNewclip Technics20260—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K262344Large Compression ScrewsTriMed, Inc.20260—
+4K261511Xpert AnkleNewclip Technics20260—
+4K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K261241TriMed Compression ScrewsTriMed, Inc.20260—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+4K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+4K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+4K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+4K254182AsterOsteonic Co., Ltd.20260—
+4K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+4K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+4K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+4K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+4K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+4K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+4K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+4K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+4K250155Xpert KneeNewclip Technics20250—
+4K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+4K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+4K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+4K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+4K241539Activmotion SNewclip Technics20240—
+4K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+4K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+4K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+4K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+4K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+4K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+4K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+4K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+4K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+4K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+4K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+4K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+4K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG20232—
+4K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+4K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+4K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+4K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+4K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+4K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+4K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+4K213572JuniOrtho Plating System™Orthofix Srl20220—
+4K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+4K211051DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)DePuy Synthes20211—
+4K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+4K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+4K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+4K202307Activ FuseNewclip Technics20200—