510(k) Report

Devices descending from K993289

182 later devices reach Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K173746Activmotion RangeNewclip Technics20181—
+4K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+4K171108AUTOBAHN Nailing SystemGlobus Medical, Inc.20172—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+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—
+4K150867Affixus Tibial Nailing SystemBiomet, Inc.20153—
+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—
+4K113695Ellipse Precice Trauma Nail SystemEllipse Technologies, Inc.201232
+4K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa)2011181
+4K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+4K090091Olecranail Intramedullary Fixation SystemMylad Orthopedic Solutions, LLC20091—
+4K070444Aos Tibial NailAdvanced Orthopaedic Solutions, Inc.20074—
+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—
+5K241539Activmotion SNewclip Technics20240—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp.20232—
+5K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+5K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+5K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc.20221—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+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—
+5K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+5K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+5K141447Precice Trauma Nail SystemEllipse Technologies, Inc.20142—
+5K133081Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…Advanced Orthopaedic Solutions, Inc.20132—
+5K131365T2 Tibial Nailing SystemStryker Trauma AG2013174
+5K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+5K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+5K13062512MM and 13MM Tibial NailsAdvanced Orthopaedic Solutions, Inc.20133—
+5K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+5K110322Olecra Intramedullary Fixation SystemMylad Orthopedic Solutions20110—
+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—
+6K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.20251—
+6K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon…Stryker GmbH202011—
+6K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+6K181091AxSOS 3 TiStryker GmbH201811—
+6K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+6K163589SIGN IM NailSign Fracture Care International20170—
+6K142599PRECISE Trauma Nail SystemEllipse Technologies, Incorporated20151—
+6K141103Intramedullary Nail and Screws-NeonailNeoortho Produtos Ortopedicos S/A20141—
+7K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—
+7K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+7K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K230088Ankle Truss System (ATS)4Web Medical, Inc.20241—
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+7K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+7K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+7K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH20217—
+7K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+7K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+7K152370PRECICE Trauma Nail SystemEllipse Technologies, Incorporated20150—
+8K260810Anteralign LS coverplateTyber Medical, LLC20260—
+8K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+8K242356TIDAL Fusion Cage SystemRestor3D, Inc.20250—
+8K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—