510(k) Report

Devices descending from K061400

53 later devices reach Calcaneal Trauma System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113048Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201252—
+2K161037Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc.20169—
+2K153379AxSOS 3TiStryker GmbH201625—
+2K141905Pro-Link Wedge SystemLife Spine201411—
+2K122005Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201239—
+3K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+3K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+3K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+3K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+3K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+3K172350AxSOS 3 TiStryker GmbH201717—
+3K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+3K150368Tarsa-Link Wedge Fixation SystemLife Spine201510—
+3K123203Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc.201238—
+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—
+4K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+4K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+4K181091AxSOS 3 TiStryker GmbH201811—
+4K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+4K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+4K132591Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201332—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+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—
+5K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+5K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+5K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+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—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+6K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+6K143092Tensyn PlugDallen Medical, Inc.20151—
+7K252246Leforte MMF SystemJeil Medical Corporation20260—
+7K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+7K150359Tensyn PlugDallen Medical, Inc.20150—