510(k) Report

Devices descending from K954385

494 later devices reach Synthes Mandibular Modular Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K151387Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver BladeStryker20152—
+6K131775Universal Neuro 3 SystemStryker20130—
+6K130431Compressyn BandDallen Medical, Inc.20134—
+6K120352Stryker Quikflap Sterile Procedure PackStryker2012418
+6K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc20129712
+6K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc.20101191
+6K101962Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.2010851
+6K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+6K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc.2010339—
+7K261892ProRib Fixation SystemCosta Surgical, Inc.20260—
+7K254053APS Spear Locking PlateA Plus Biotechnology Co., Ltd.20260—
+7K253660KLS Martin Pure Pectus SystemKLS-Martin L.P.20260—
+7K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20252—
+7K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+7K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+7K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+7K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+7K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+7K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+7K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+7K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+7K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+7K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20211—
+7K200062Foot and Ankle SystemLeith Medical, LLC20210—
+7K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+7K200513DAC Dynamic Active Compression PlatePioneer Surgical Technology, Inc., Dba Rti Surgical20200—
+7K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+7K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+7K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+7K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+7K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+7K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+7K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+7K171152Stryker Universal Neuro III System AXS ScrewStryker20171—
+7K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+7K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+7K142581APTUS Foot SystemMedartis AG201522—
+7K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+7K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+7K140309CranioplugOssdsign AB20142—
+7K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.20140—
+7K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+7K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+7K140376Variax 2 SystemStryker Trauma AG201423—
+7K133858Tensyn BandDallen Medical, Inc.20143—
+7K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+7K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc201295—
+7K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+7K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+7K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+7K120157Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201264—
+7K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+7K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+7K113048Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201252—
+7K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+7K111041Mini Variable SystemOrthohelix Surgical Designs, Inc.201177—
+8K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+8K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+8K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+8K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+8K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+8K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20260—
+8K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+8K253906Xpert HandNewclip Technics20260—
+8K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+8K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+8K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+8K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+8K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+8K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+8K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+8K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+8K242988Genostis Osteosynthesis SystemGenostis AF20250—
+8K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+8K243469SignexOsteonic Co., Ltd.20250—
+8K250892CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20251—
+8K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+8K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+8K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+8K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+8K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+8K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+8K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+8K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+8K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+8K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+8K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+8K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+8K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+8K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—