510(k) Report

Devices descending from K954385

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC20200—
+1K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+1K121574Synthes Matrixmadible Plate and Screw SystemSynthes, Inc.20121—
+1K072463Satyrne Interflex Mandibular Fixation SystemSatyrne Medical20070—
+1K992682Modus 2.5 Mandibular Reconstruction SetMedartis AG19992—
+1K981890Synthes (Usa) [Synthes] MMFS - 2.0 MM Sagittal Split PlatesSynthes (Usa)199835—
+1K974555Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa)1998457—
+2K113567Synthes Matrixmadible Plate and Screw SystemSynthes, Inc.20124—
+2K071612Modus Trilock 2.0/2.3/2.5Medartis AG20070—
+2K032520Ortrautek Trauma SystemTekka20030—
+2K032442KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P.2003435—
+2K031989Ortrautek Orthognathic SystemTekka20035—
+2K030448Osteomed 2.0 Locking Plates and ScrewsOsteomed LP2003444—
+2K013672Bruges Distraction - Anchoring - Osteosynthesis SystemAzary Technologies, LLC20020—
+2K993862Modus Sagittal Split PlateThe Straumann Co.199934—
+3K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.20241—
+3K180962KLS Martin Individual Patient SolutionsKLS-Martin L.P.20180—
+3K163579KLS Martin Individual Patient SolutionsKLS Martin L.P.20179—
+3K140037Optimus CMF SystemOsteonic Co., Ltd.20152—
+3K091812Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible…Frontier Devices, Inc.20104—
+3K090522Osteomed Hand Plate and Screw Fixation SystemOsteomed LP200915—
+3K080694Osteomed Modular Locking Fixation SystemOsteomed LP20082—
+3K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P.200665—
+3K040598KLS Martin Hand Plating SystemKLS-Martin L.P.2004360—
+3K022185Universal CMF SystemStryker Instruments200233—
+4K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P.20260—
+4K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd.20250—
+4K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…KLS-Martin L.P.20250—
+4K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+4K220360Tandry CMF Plate SystemMicroware Precision Co., Ltd.20220—
+4K221855Universal CMF SystemStryker Leibinger GmbH & Co KG20221—
+4K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+4K191028KLS Martin Individual Patient SolutionsKLS-Martin L.P.20197—
+4K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE20190—
+4K170773Stryker Universal MeshStryker20171—
+4K172572Stryker Upper-Face AXS screws and Mid-Face AXS screwsStryker20170—
+4K171364MP LeFort I PlatesStryker20170—
+4K161821Stryker Universal MeshStryker20162—
+4K160363Optimus CMF SystemOsteonic Co., Ltd.20160—
+4K143338Argulated Locking PlatesOsteomed LP20150—
+4K141764Tristar Bone Graft Fixation SystemImpladent, Ltd.20143—
+4K141489Linos Moh Hand Plating SystemKLS Martin L.P.20143—
+4K132769Acumed Hand Plating SystemAcumed, LLC20147—
+4K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation2013111
+4K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation2013142
+4K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+4K111419Osteomed Hand Fusion SystemOsteomed LP20111—
+4K091807Medpor Fixation SystemPorex Surgical, Inc.20100—
+4K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.200761—
+4K050868MaxlockOrthohelix Surgical Designs, Inc.2005343—
+4K041651Stryker Leibinger Skeletal Anchoring SystemStryker Leibinger20044—
+4K031659Universal Neuro SystemStryker Instruments200312—
+5K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+5K240651MRI UniversalStryker Leibinger GmbH & Co KG20240—
+5K230398MedCAD® AccuPlate® 3DTi Patient-Specific Plating SystemMedcad20230—
+5K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+5K210731KLS Martin Individual Patient SolutionsKLS-Martin L.P.20223—
+5K203282TECHFIT Patient-Specific Maxillofacial SystemIndustrias Medicas Sampedro S.A.S20211—
+5K182425Universal Mesh - SterileStryker Leibinger GmbH & Co KG201801
+5K170697GBR systemSurgident20182—
+5K170725Stryker Universal MeshStryker20170—
+5K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+5K170124Level One Hand Plating SystemKLS Martin L.P.20172—
+5K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—
+5K151983KLS Martin LSS Plating SystemKLS Martin L.P.201645—
+5K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+5K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+5K141123Alliance Spine Raas Cranial Plating SystemAlliance Partners, LLC20150—
+5K142484Sternal Closure SystemJace Medical, LLC20141—
+5K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+5K141383Acumed Hand Fracture SystemAcumed, LLC20146—
+5K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+5K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+5K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+5K130120Extremity Medical IP Fusion SystemExtremity Medical, LLC20130—
+5K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+5K112557Stryker Universal Neuro 3 SystemStryker20129—
+5K101484Compressyn BandDallen Medical20115—
+5K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+5K091051Bollard Miniplate Skeletal Anchorage SystemTita-Link20091—
+5K073624Modular Foot SystemOrthohelix Surgical Designs, Inc.20083421
+5K063386Lorenz Orthodontic Anchorage SystemWalter Lorenz Surgical, Inc.20070—
+5K051798Osteomed Orthodontic Anchor Plating SystemOsteomed LP20060—
+6K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.20260—
+6K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.20240—
+6K232350Stryker Facial iD SystemStryker Craniomaxillofacial20240—
+6K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.20233—
+6K221938KLS Martin Pure Pectus SystemKLS Martin L.P.20236—
+6K222367Save GBRDentis Co., Ltd.20230—
+6K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+6K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+6K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+6K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices202139—
+6K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+6K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLC20200—
+6K173623Anchor plateBiomaterials Korea, Inc.20180—
+6K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+6K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+6K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+6K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—