510(k) Report

Devices descending from K003077

342 later devices reach Smartscrew Model 222006...227510 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K200124InCore MPJ SystemNextremity Solutions, Inc.20200—
+5K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+5K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+5K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+5K192578InCore TMT SystemNextremity Solutions, Inc.20191—
+5K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+5K191972ARIX Wrist SystemJeil Medical Corporation20190—
+5K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+5K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+5K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+5K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+5K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+5K190231InCore® Lapidus Sterile KitsNextremity Solutions, Inc.20190—
+5K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+5K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+5K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+5K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+5K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+5K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+5K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+5K162198GFS UltimateParcus Medical, LLC20168—
+5K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+5K142653G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporation, Ltd.20140—
+5K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+5K140328CMC Mini TightropeArthrex, Inc.20146—
+5K133757GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC201416—
+5K132502Variax 2 SystemStryker Trauma AG201321—
+5K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+6K254280F.A.S.T ScrewSteps Ortho20260—
+6K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+6K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+6K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+6K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+6K254215Arthrex Beaming SystemArthrex, Inc.20261—
+6K252246Leforte MMF SystemJeil Medical Corporation20260—
+6K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+6K254176SinefixBAAT Medical Products B.V.20260—
+6K260405FiberTape ButtonArthrex, Inc.20260—
+6K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+6K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+6K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+6K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+6K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+6K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+6K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+6K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+6K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+6K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+6K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+6K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+6K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+6K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+6K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+6K223795FairFix QT Adjustable ButtonMedacta International S.A.20230—
+6K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+6K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+6K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+6K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+6K222169FairFix Adjustable Button SystemMedacta International S.A.20220—
+6K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+6K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A.20220—
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+6K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+6K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+6K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+6K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+6K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+6K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+6K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation20190—
+6K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation20190—
+6K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+6K183331Parcus GFS BTBParcus Medical, LLC20193—
+6K173556Injection ScrewBiedermann Medtech, Inc.20180—
+6K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+6K160655OrthoButton CLRiverpoint Medical20169—
+6K152711Parcus GFS NakedParcus Medical, LLC20154—
+6K140769Variax 2 SystemStryker Trauma AG201419—
+7K262975Arthrex Beaming SystemArthrex, Inc.20260—
+7K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+7K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+7K243203OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorRiverpoint Medical20240—
+7K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K240719OC JuggerKnot Soft AnchorRiverpoint Medical20240—
+7K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+7K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+7K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+7K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+7K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+7K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—