510(k) Report

Devices descending from K954385

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+8K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+8K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+8K221395Footmotion Plating SystemNewclip Technics20220—
+8K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+8K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+8K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+8K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+8K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+8K211435PAO Cortical ScrewMedacta International S.A.20210—
+8K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+8K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+8K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+8K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+8K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+8K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+8K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+8K192356Airlock Centrolock Osteosynthesis Implant SystemNovastep20192—
+8K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+8K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+8K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+8K191636APTUS Foot SystemMedartis AG20190—
+8K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+8K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+8K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+8K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+8K181539OSSDSIGN CranioplugOssdsign AB20181—
+8K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+8K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+8K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+8K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+8K172886Breakaway Screw SystemParagon 2820174—
+8K172300CoLink View Plating SystemIn2bones USA, LLC201716—
+8K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+8K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+8K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+8K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+8K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+8K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+8K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+8K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+8K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+8K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+8K161448Footmotion Plating SystemNewclip Technics20165—
+8K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+8K161037Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc.20169—
+8K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+8K153379AxSOS 3TiStryker GmbH201625—
+8K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+8K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+8K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc201522—
+8K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+8K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+8K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc201523—
+8K151407RECON systemNormed Medizin-Technik GmbH20154—
+8K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+8K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+8K151235Medline Foot Plates and ScrewsMedline Industries, Inc.201510—
+8K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+8K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+8K143365Eminent Foot Plate SystemEminent Spine20151—
+8K143717Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201512—
+8K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+8K143025Total Compression Plating SystemWrightmedicaltechnologyinc201424—
+8K141905Pro-Link Wedge SystemLife Spine201411—
+8K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+8K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+8K141992Variax 2 SystemStryker Trauma AG201422—
+8K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+8K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+8K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+8K122005Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201239—
+8K121437Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201238—
+9K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+9K261191Alians Elbow SNewclip Technics20260—
+9K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+9K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+9K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+9K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+9K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+9K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.20260—
+9K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+9K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+9K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+9K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+9K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+9K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+9K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+9K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+9K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+9K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+9K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+9K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+9K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+9K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+9K240487EVOS Patella PlatesSmith & Nephew20240—