510(k) Report

Devices descending from K102156

119 later devices reach Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113048Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201252—
+1K111041Mini Variable SystemOrthohelix Surgical Designs, Inc.201177—
+2K161037Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc.20169—
+2K153379AxSOS 3TiStryker GmbH201625—
+2K141905Pro-Link Wedge SystemLife Spine201411—
+2K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+2K122005Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201239—
+2K120157Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201264—
+3K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+3K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+3K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+3K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+3K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+3K192356Airlock Centrolock Osteosynthesis Implant SystemNovastep20192—
+3K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+3K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+3K172350AxSOS 3 TiStryker GmbH201717—
+3K172300CoLink View Plating SystemIn2bones USA, LLC201716—
+3K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+3K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+3K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+3K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+3K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+3K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+3K150368Tarsa-Link Wedge Fixation SystemLife Spine201510—
+3K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+3K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+3K123203Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc.201238—
+3K121437Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201238—
+4K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+4K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+4K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+4K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+4K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+4K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+4K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+4K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+4K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+4K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K191867ATLAS Plating SystemMiRus, LLC20200—
+4K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+4K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+4K181091AxSOS 3 TiStryker GmbH201811—
+4K182402CoLink View Plating SystemIn2bones USA, LLC20182—
+4K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+4K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+4K172886Breakaway Screw SystemParagon 2820174—
+4K172178Minimally Invasive Bunion Plating SystemTrilliant Surgical, Ltd.20174—
+4K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+4K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+4K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+4K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+4K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+4K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+4K132591Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201332—
+5K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+5K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+5K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+5K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+5K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+5K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+5K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+5K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+5K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+5K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+5K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+5K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+5K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+5K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+5K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—