510(k) Report

Devices descending from K043185

405 later devices reach Synthes 3.5MM Cortex Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+4K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+4K173746Activmotion RangeNewclip Technics20181—
+4K173641Activ AnkleNewclip Technics20183—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+4K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+4K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+4K170843Alians Fragment SpecificNewclip Technics20171—
+4K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+4K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+4K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+4K153379AxSOS 3TiStryker GmbH201625—
+4K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+4K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+4K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+4K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+4K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+4K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+4K143365Eminent Foot Plate SystemEminent Spine20151—
+4K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+4K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+4K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+5K254280F.A.S.T ScrewSteps Ortho20260—
+5K261191Alians Elbow SNewclip Technics20260—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+5K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+5K252246Leforte MMF SystemJeil Medical Corporation20260—
+5K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+5K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+5K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+5K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+5K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+5K241539Activmotion SNewclip Technics20240—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+5K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+5K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+5K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+5K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+5K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+5K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+5K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+5K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+5K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+5K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+5K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+5K192592Axis Plating SystemExtremity Medical, LLC20190—
+5K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+5K191009Arsenal Plating SystemTrilliant Surgical20192—
+5K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+5K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+5K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+5K172350AxSOS 3 TiStryker GmbH201717—
+5K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+5K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+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—
+6K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+6K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+6K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+6K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+6K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+6K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+6K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+6K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+6K181091AxSOS 3 TiStryker GmbH201811—
+7K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+7K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+7K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+7K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+7K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+7K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+7K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123