510(k) Report

Devices descending from K022325

521 later devices reach Normed Titanium Osteotomy Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+4K220136Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20228—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+4K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+4K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K211435PAO Cortical ScrewMedacta International S.A.20210—
+4K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+4K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+4K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+4K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+4K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+4K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+4K200513DAC Dynamic Active Compression PlatePioneer Surgical Technology, Inc., Dba Rti Surgical20200—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+4K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+4K192696TriMed ASET Foot Plating SystemTriMed, Inc.20201—
+4K192356Airlock Centrolock Osteosynthesis Implant SystemNovastep20192—
+4K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+4K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+4K192592Axis Plating SystemExtremity Medical, LLC20190—
+4K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+4K192504Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201910—
+4K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+4K191636APTUS Foot SystemMedartis AG20190—
+4K191009Arsenal Plating SystemTrilliant Surgical20192—
+4K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+4K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+4K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+4K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+4K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+4K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+4K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+4K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+4K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc.20182—
+4K182402CoLink View Plating SystemIn2bones USA, LLC20182—
+4K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+4K171690Trident Extremity Fixation SystemTrident Orthopedics20180—
+4K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+4K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+4K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+4K172300CoLink View Plating SystemIn2bones USA, LLC201716—
+4K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+4K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172—
+4K170843Alians Fragment SpecificNewclip Technics20171—
+4K162380Locking Plate SystemBeijing Keyi Medical Device Technology Co., Ltd.20170—
+4K170012Foot and Hand MotionNewclip Technics20170—
+4K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+4K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+4K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+4K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+4K161037Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc.20169—
+4K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+4K153379AxSOS 3TiStryker GmbH201625—
+4K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+4K151508IRENE Locking Compression Plate SystemTianjin Zhengtian Medical Instrument Co., Ltd.20160—
+4K153531Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201611—
+4K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+4K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+4K143721PRCT2Fx Solutions20150—
+4K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+4K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+4K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+4K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+4K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20150—
+4K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+4K143614Arthrex Low Profile ScrewsArthrex, Inc.201519—
+4K141905Pro-Link Wedge SystemLife Spine201411—
+4K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.20140—
+4K141992Variax 2 SystemStryker Trauma AG201422—
+4K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+4K133662Smith & Nephew Cannulated Captured ScrewSmith & Nephew, Inc.20148—
+4K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+4K132911I.B.S Snap-Off Screw / Solafix Snap-Off ScrewIn2bones Sas20140—
+4K133691Extrimilock Ankle Plating SystemOsteomed LP201410—
+4K130614Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga20142—
+4K1334371ST MTP PlateOsteomed20132—
+4K132217Arthrex Compression FT ScrewsArthrex, Inc.201318—
+4K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+4K131186Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSynthes (USA) Products, LLC20138—
+4K132642Locking Plate SystemBeijing Libeier Bio-Engineering Institute Co., Ltd.20130—
+4K131061Restore Bunion Correction SystemNextremity Solutions201315—
+4K131759Metallic Locking Compression Bone Plates and Screws SystemTianjin Walkman Biomaterial Co., Ltd.20131—
+4K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+4K130340Locking Bone Plates and ScrewsWeigao Orthopaedic Device Co., Ltd.20137—
+4K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+4K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+4K122005Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201239—
+4K120157Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201264—
+4K112798Locking Compression Plate SystemShanghai Microport Orthopedics Co., Ltd.20120—
+4K112437Arthrex Fracture SystemArthrex, Inc.201191—
+4K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011135—