510(k) Report

Devices descending from K063049

468 later devices reach Synthes (Usa) Modular Mini Fragment LCP System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+3K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+3K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+3K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20220—
+3K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+3K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+3K213214Xpert WristNewclip Technics20210—
+3K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+3K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+3K211435PAO Cortical ScrewMedacta International S.A.20210—
+3K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+3K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+3K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+3K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+3K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+3K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+3K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+3K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+3K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+3K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+3K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+3K201149CoLink Plating SystemIn2bones USA, LLC20200—
+3K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+3K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+3K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+3K193554APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemMedartis AG20208—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+3K192356Airlock Centrolock Osteosynthesis Implant SystemNovastep20192—
+3K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+3K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+3K191972ARIX Wrist SystemJeil Medical Corporation20190—
+3K191848APTUS Wrist Spanning Plates 2.5Medartis AG20192—
+3K191636APTUS Foot SystemMedartis AG20190—
+3K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+3K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+3K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+3K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+3K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+3K182402CoLink View Plating SystemIn2bones USA, LLC20182—
+3K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+3K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+3K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+3K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+3K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+3K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+3K172886Breakaway Screw SystemParagon 2820174—
+3K172008ARIX Humerus SystemJeil Medical Corporation20173—
+3K172300CoLink View Plating SystemIn2bones USA, LLC201716—
+3K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+3K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+3K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+3K170705ARIX Wrist SystemJeil Medical Corporation20172—
+3K172170APTUS (R) Wrist 2.5 SystemMedartis AG20178—
+3K171285ARIX Diaphysis SystemJeil Medical Corporation20176—
+3K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+3K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+3K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+3K170843Alians Fragment SpecificNewclip Technics20171—
+3K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+3K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+3K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+3K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+3K161861APTUS® Coronoid 2.0Medartis AG20170—
+3K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+3K161037Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc.20169—
+3K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+3K153379AxSOS 3TiStryker GmbH201625—
+3K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+3K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc201522—
+3K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+3K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+3K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+3K151407RECON systemNormed Medizin-Technik GmbH20154—
+3K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+3K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+3K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+3K143365Eminent Foot Plate SystemEminent Spine20151—
+3K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+3K143139Arthrex Fracture SystemArthrex, Inc.20151—
+3K141905Pro-Link Wedge SystemLife Spine201411—
+3K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+3K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+3K141992Variax 2 SystemStryker Trauma AG201422—
+3K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+3K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+3K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+3K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+3K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+3K122005Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201239—
+3K121437Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201238—
+4K262975Arthrex Beaming SystemArthrex, Inc.20260—
+4K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+4K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+4K261511Xpert AnkleNewclip Technics20260—
+4K261191Alians Elbow SNewclip Technics20260—