510(k) Report

Devices descending from K030858

106 later devices reach Synthes (Usa) LCP Proximal Femur Plate and Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+1K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+1K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+1K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615—
+1K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+1K141680AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN…Auxein Medical20151—
+1K072818Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe AccessSmith & Nephew, Inc.200793—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K201510Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V.20220—
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+2K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+2K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+2K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics20181—
+2K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+2K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+2K112406Peri-Loc Proximal Femur Locking Bone PlatesSmith & Nephew, Inc.20113—
+2K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc.201038—
+2K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.2009772
+2K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc.200835—
+3K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+3K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+3K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K182154Depuy Synthes Femoral Neck SystemSynthes (USA) Products, LLC20181—
+3K173746Activmotion RangeNewclip Technics20181—
+3K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc.201713—
+3K161665VLP Wrist Fracture SystemSmith & Nephew, Inc.201610—
+3K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+3K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+3K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426—
+3K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+3K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+3K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+3K132296D-Rad Smart PackSmith & Nephew, Inc.2014114
+3K090656Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc.200934—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+4K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+4K241539Activmotion SNewclip Technics20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+4K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+4K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+4K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+4K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+4K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+4K153379AxSOS 3TiStryker GmbH201625—
+4K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+4K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+4K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+4K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+5K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+5K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+5K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+5K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+5K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc.20208—
+5K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc.20199—
+5K172350AxSOS 3 TiStryker GmbH201717—
+5K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+6K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+6K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+6K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K181091AxSOS 3 TiStryker GmbH201811—
+7K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+7K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+7K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—