510(k) Report

Devices descending from K030198

678 later devices reach Hand Innovations, Inc. Distal Radius Fracture Repair System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+5K151735TriMed Humeral Supracondylar Fixation SystemTriMed, Inc.20160—
+5K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+5K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+5K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+5K151379Conventus PRS SystemConventus Orthopaedics, Inc.20151—
+5K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+5K141737Conventus PHS SystemConventus Orthopaedics, Inc.20150—
+5K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+5K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+5K141677Variax Elbow Plating SystemStryker Trauma AG20140—
+5K141430Variax Distal Radius Plating SystemStryker Leibinger GmbH & Co KG201412—
+5K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426—
+5K140769Variax 2 SystemStryker Trauma AG201419—
+5K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+5K131552Conventus DRSConventus Orthopaedics20142—
+5K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc.20131—
+5K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+5K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+5K122310Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC20130—
+5K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+5K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC201228—
+5K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+5K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+5K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+5K102095Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20102—
+5K100944Clavicle Locking Plate SystemNewclip Technics20109—
+5K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH201011
+5K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp.201013—
+5K093983Smple Plate and ScrewsBiomet Trauma (Aka Ebi, Lp)20100—
+5K091156Trimed Sterile ProductTriMed, Inc.20090—
+5K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+5K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+6K262649Alians ForearmNewclip Technics20260—
+6K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+6K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+6K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+6K250155Xpert KneeNewclip Technics20250—
+6K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+6K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+6K242055Freefix Forearm Plating SystemSkeletal Dynamics, Inc.20240—
+6K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+6K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+6K213572JuniOrtho Plating System™Orthofix Srl20220—
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+6K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+6K211051DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)DePuy Synthes20211—
+6K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc.20208—
+6K200226RetroFixRetrofix Screws, LLC20200—
+6K200246JPS JuniOrtho Plating SystemOrthofix Srl20201—
+6K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+6K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+6K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc.20199—
+6K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+6K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+6K173135VariAx 2 SystemStryker GmbH201713—
+6K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+6K172262EVOS Small Fragment Plating SystemSmith & Nephew, Inc.20179—
+6K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+6K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+6K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+6K170310Alians Clavicle rangeNewclip Technics20170—
+6K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…DePuy Synthes20176—
+6K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+6K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+6K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+6K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+6K162635Distal Radius Plating SystemMiami Device Solutions, LLC20162—
+6K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+6K153379AxSOS 3TiStryker GmbH201625—
+6K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+6K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+6K151407RECON systemNormed Medizin-Technik GmbH20154—
+6K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+6K150626Rush Medullary PinsZimmer, Inc.20150—
+6K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+6K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+6K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+6K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+6K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+6K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+6K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+6K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+6K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+6K124027Monster Screw SystemApogee Orthosolutions201341—
+6K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+6K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+6K113405Suspension Clavicle Fracture Repair SystemSuspension Orthopaedic Solutions, LLC20120—
+6K112923Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20110—
+6K112509Trimed Clavicle Fixation SystemTriMed, Inc.20111—
+6K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+6K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+6K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+6K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+7K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+7K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—