510(k) Report

Devices descending from K031712

382 later devices reach Inion Otps Biodegradable Pin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K130814Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company20133—
+5K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+5K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+5K111032CMC Cable FixInstratek, Inc.20112—
+5K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+5K090923Parcus Graft Fixation SystemParcus Medical, LLC200921—
+6K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+6K261511Xpert AnkleNewclip Technics20260—
+6K260761APTUS Clavicle System 2.8Medartis AG20260—
+6K254182AsterOsteonic Co., Ltd.20260—
+6K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+6K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+6K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+6K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+6K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+6K243469SignexOsteonic Co., Ltd.20250—
+6K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+6K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+6K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+6K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+6K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+6K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+6K241539Activmotion SNewclip Technics20240—
+6K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+6K241235Arthrex TightRope IIArthrex, Inc.20243—
+6K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+6K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+6K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+6K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+6K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+6K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+6K220966SinefixBAAT Medical Products B.V.20231—
+6K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+6K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+6K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+6K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+6K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+6K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+6K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+6K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—
+6K202307Activ FuseNewclip Technics20200—
+6K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+6K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+6K201149CoLink Plating SystemIn2bones USA, LLC20200—
+6K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+6K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+6K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+6K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+6K191972ARIX Wrist SystemJeil Medical Corporation20190—
+6K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+6K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+6K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+6K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+6K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+6K190658MIS Bunion Plating SystemCrossroads Extremity Systems, LLC20192—
+6K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+6K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+6K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+6K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+6K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+6K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+6K162198GFS UltimateParcus Medical, LLC20168—
+6K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+6K142653G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporation, Ltd.20140—
+6K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+6K140328CMC Mini TightropeArthrex, Inc.20146—
+6K133757GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC201416—
+6K132502Variax 2 SystemStryker Trauma AG201321—
+6K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+7K254280F.A.S.T ScrewSteps Ortho20260—
+7K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+7K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+7K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+7K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+7K254215Arthrex Beaming SystemArthrex, Inc.20261—
+7K252246Leforte MMF SystemJeil Medical Corporation20260—
+7K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+7K254176SinefixBAAT Medical Products B.V.20260—
+7K260405FiberTape ButtonArthrex, Inc.20260—
+7K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+7K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+7K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+7K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+7K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+7K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+7K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+7K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+7K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+7K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+7K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+7K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+7K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+7K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+7K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+7K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+7K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+7K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—