510(k) Report

Devices descending from K052776

217 later devices reach Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+4K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+4K243469SignexOsteonic Co., Ltd.20250—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+4K241539Activmotion SNewclip Technics20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+4K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+4K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+4K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+4K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+4K223795FairFix QT Adjustable ButtonMedacta International S.A.20230—
+4K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+4K222169FairFix Adjustable Button SystemMedacta International S.A.20220—
+4K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A.20220—
+4K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+4K202307Activ FuseNewclip Technics20200—
+4K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+4K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+4K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+4K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+4K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+4K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+4K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+4K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+4K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+4K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+4K183331Parcus GFS BTBParcus Medical, LLC20193—
+4K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+4K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+4K173556Injection ScrewBiedermann Medtech, Inc.20180—
+4K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+4K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+4K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+4K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+4K160655OrthoButton CLRiverpoint Medical20169—
+4K152711Parcus GFS NakedParcus Medical, LLC20154—
+4K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+4K140769Variax 2 SystemStryker Trauma AG201419—
+4K140328CMC Mini TightropeArthrex, Inc.20146—
+5K254280F.A.S.T ScrewSteps Ortho20260—
+5K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+5K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+5K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+5K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+5K254215Arthrex Beaming SystemArthrex, Inc.20261—
+5K252246Leforte MMF SystemJeil Medical Corporation20260—
+5K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+5K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+5K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+5K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+5K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+5K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+5K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+5K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+5K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—
+5K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+5K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+5K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+5K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+5K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+5K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+5K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+5K212739ActiFlipParcus Medical, LLC20210—
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+5K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+5K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation20190—
+5K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation20190—
+5K173135VariAx 2 SystemStryker GmbH201713—
+5K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+5K171060OrthoButton ALRiverpoint Medical20178—
+5K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+6K262975Arthrex Beaming SystemArthrex, Inc.20260—
+6K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+6K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K240835Suture Button Repair SystemSkeletal Dynamics, Inc.20241—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K240194ProCinch, QuadCinchRiverpoint Medical20240—
+6K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+6K233552IDEAL ZiploopRiverpoint Medical20230—
+6K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+6K230212OrthoButton ALRiverpoint Medical, LLC20232—
+6K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+6K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+6K202399OrthoButton FLRiverpoint Medical20201—
+6K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—