510(k) Report

Devices descending from K043059

207 later devices reach Compression Staple and Simple Staple through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+4K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+4K122005Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201239—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+5K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+5K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP20241—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+5K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+5K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+5K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+5K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+5K220136Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20228—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+5K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+5K200062Foot and Ankle SystemLeith Medical, LLC20210—
+5K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+5K200226RetroFixRetrofix Screws, LLC20200—
+5K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+5K192696TriMed ASET Foot Plating SystemTriMed, Inc.20201—
+5K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+5K192504Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201910—
+5K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc.20182—
+5K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+5K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+5K171690Trident Extremity Fixation SystemTrident Orthopedics20180—
+5K172886Breakaway Screw SystemParagon 2820174—
+5K172350AxSOS 3 TiStryker GmbH201717—
+5K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+5K171510Footmotion Plating SystemNewclip Technics20171—
+5K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+5K170843Alians Fragment SpecificNewclip Technics20171—
+5K170012Foot and Hand MotionNewclip Technics20170—
+5K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+5K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+5K153531Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201611—
+5K150368Tarsa-Link Wedge Fixation SystemLife Spine201510—
+5K123203Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc.201238—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+6K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+6K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+6K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—
+6K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+6K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+6K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+6K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+6K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+6K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+6K211843PolyLock Plating SystemFusion Orthopedics20220—
+6K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+6K213214Xpert WristNewclip Technics20210—
+6K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+6K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+6K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+6K200961Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20209—
+6K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+6K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+6K181091AxSOS 3 TiStryker GmbH201811—
+6K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+6K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+6K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+6K132591Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201332—
+7K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+7K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+7K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+7K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+7K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+7K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+7K201149CoLink Plating SystemIn2bones USA, LLC20200—
+7K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+7K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+7K192592Axis Plating SystemExtremity Medical, LLC20190—
+7K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+7K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+7K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+7K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+8K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+8K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+8K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—