510(k) Report

Devices descending from K033995

624 later devices reach 3.5 MM LCP Distal Humerus System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K200062Foot and Ankle SystemLeith Medical, LLC20210—
+4K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+4K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+4K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc.20208—
+4K200246JPS JuniOrtho Plating SystemOrthofix Srl20201—
+4K191972ARIX Wrist SystemJeil Medical Corporation20190—
+4K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+4K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+4K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+4K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc.20199—
+4K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+4K173556Injection ScrewBiedermann Medtech, Inc.20180—
+4K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+4K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+4K172262EVOS Small Fragment Plating SystemSmith & Nephew, Inc.20179—
+4K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+4K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+4K170310Alians Clavicle rangeNewclip Technics20170—
+4K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…DePuy Synthes20176—
+4K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+4K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+4K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+4K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+4K162635Distal Radius Plating SystemMiami Device Solutions, LLC20162—
+4K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+4K153379AxSOS 3TiStryker GmbH201625—
+4K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+4K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+4K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+4K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+4K151407RECON systemNormed Medizin-Technik GmbH20154—
+4K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+4K150626Rush Medullary PinsZimmer, Inc.20150—
+4K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+4K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+4K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+4K142502Alians Ulna Locking Plating SystemNewclip Technics20142—
+4K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+4K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+4K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+4K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+4K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+4K130774Universal Distal Radius SystemNewclip Technics20135—
+4K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+4K124027Monster Screw SystemApogee Orthosolutions201341—
+4K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+4K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+4K113405Suspension Clavicle Fracture Repair SystemSuspension Orthopaedic Solutions, LLC20120—
+4K112923Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20110—
+4K112509Trimed Clavicle Fixation SystemTriMed, Inc.20111—
+4K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+4K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+4K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+4K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+5K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+5K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+5K253906Xpert HandNewclip Technics20260—
+5K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemSynthes GmbH20260—
+5K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+5K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+5K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+5K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+5K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+5K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+5K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+5K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+5K230805TriMed Clavicle Fixation SystemTriMed, Inc.20230—
+5K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K231333STRETTO™ Cable SystemGlobus Medical, Inc.20230—
+5K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+5K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+5K221342REDEMPTION Beaming SystemVilex, LLC20220—
+5K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+5K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+5K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+5K202326BESPA Charcot SystemBespa Global, LLC20210—
+5K210953SMART Taylor Spatial FrameSmith & Nephew, Inc.20212—
+5K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+5K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+5K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+5K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+5K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+5K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+5K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+5K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+5K193368Smart Correction SystemWishbone Medical, Inc.202031
+5K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+5K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+5K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+5K193029Conquest FNSmith & Nephew, Inc.202010—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—