510(k) Report

Devices descending from K002775

719 later devices reach Distal Volar Radius Fracture Repair System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+7K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+7K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+7K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+7K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+7K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+7K200538Skeletal Dynamics Forearm Plating SystemSkeletal Dynamics, Inc.20201—
+7K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+7K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+7K192592Axis Plating SystemExtremity Medical, LLC20190—
+7K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+7K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+7K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+7K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+7K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+7K170457EVOS Small Fragment Lower Extremity PlatesSmith & Nephew, Inc.2017131
+7K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc.201713—
+7K162078EVOS Small Fragment Plating SystemSmith & Nephew, Inc.2016261
+7K161292Distal Radius Plating SystemMiami Device Solutions, LLC20164—
+7K161058Cannulated ScrewMiami Device Solutions, LLC20161—
+7K161048Conventus Orthopaedics Ulna Fixation SystemConventus Orthopaedics, Inc.20160—
+7K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+7K151735TriMed Humeral Supracondylar Fixation SystemTriMed, Inc.20160—
+7K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+7K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+7K151379Conventus PRS SystemConventus Orthopaedics, Inc.20151—
+7K141737Conventus PHS SystemConventus Orthopaedics, Inc.20150—
+7K143092Tensyn PlugDallen Medical, Inc.20151—
+7K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+7K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+7K141430Variax Distal Radius Plating SystemStryker Leibinger GmbH & Co KG201412—
+7K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426—
+7K131552Conventus DRSConventus Orthopaedics20142—
+7K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc.20131—
+7K122310Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC20130—
+7K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC201228—
+7K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+7K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+7K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+7K102095Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20102—
+7K100944Clavicle Locking Plate SystemNewclip Technics20109—
+7K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH201011
+7K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp.201013—
+7K093983Smple Plate and ScrewsBiomet Trauma (Aka Ebi, Lp)20100—
+7K091156Trimed Sterile ProductTriMed, Inc.20090—
+7K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+7K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+8K262649Alians ForearmNewclip Technics20260—
+8K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+8K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+8K252246Leforte MMF SystemJeil Medical Corporation20260—
+8K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+8K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+8K250155Xpert KneeNewclip Technics20250—
+8K242055Freefix Forearm Plating SystemSkeletal Dynamics, Inc.20240—
+8K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+8K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+8K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+8K213572JuniOrtho Plating System™Orthofix Srl20220—
+8K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+8K211051DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)DePuy Synthes20211—
+8K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc.20208—
+8K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+8K200246JPS JuniOrtho Plating SystemOrthofix Srl20201—
+8K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+8K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc.20199—
+8K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+8K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+8K172262EVOS Small Fragment Plating SystemSmith & Nephew, Inc.20179—
+8K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+8K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+8K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+8K170310Alians Clavicle rangeNewclip Technics20170—
+8K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…DePuy Synthes20176—
+8K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+8K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+8K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+8K162635Distal Radius Plating SystemMiami Device Solutions, LLC20162—
+8K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+8K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+8K151407RECON systemNormed Medizin-Technik GmbH20154—
+8K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+8K150359Tensyn PlugDallen Medical, Inc.20150—
+8K150626Rush Medullary PinsZimmer, Inc.20150—
+8K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+8K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+8K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+8K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+8K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+8K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+8K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+8K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+8K124027Monster Screw SystemApogee Orthosolutions201341—
+8K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+8K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+8K113405Suspension Clavicle Fracture Repair SystemSuspension Orthopaedic Solutions, LLC20120—
+8K112923Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20110—
+8K112509Trimed Clavicle Fixation SystemTriMed, Inc.20111—