510(k) Report

Devices descending from K961608

577 later devices reach Synthes (U.S.a.) Polypin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+7K261511Xpert AnkleNewclip Technics20260—
+7K260761APTUS Clavicle System 2.8Medartis AG20260—
+7K254182AsterOsteonic Co., Ltd.20260—
+7K253763Y-Knotless™ Flex AnchorsConmed Corporation20261—
+7K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+7K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+7K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+7K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+7K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+7K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+7K243469SignexOsteonic Co., Ltd.20250—
+7K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+7K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+7K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+7K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+7K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+7K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+7K241539Activmotion SNewclip Technics20240—
+7K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+7K241235Arthrex TightRope IIArthrex, Inc.20243—
+7K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+7K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+7K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.20240—
+7K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+7K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+7K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+7K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+7K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.20233—
+7K221938KLS Martin Pure Pectus SystemKLS Martin L.P.20236—
+7K220966SinefixBAAT Medical Products B.V.20231—
+7K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+7K220757Argo Knotless SP AnchorConmed Corporation20226—
+7K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+7K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+7K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+7K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+7K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+7K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+7K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+7K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices202139—
+7K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+7K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+7K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+7K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—
+7K202307Activ FuseNewclip Technics20200—
+7K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+7K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+7K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC20203—
+7K201149CoLink Plating SystemIn2bones USA, LLC20200—
+7K200124InCore MPJ SystemNextremity Solutions, Inc.20200—
+7K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+7K193606Y-Knot OneStep AnchorConmed Corporation20200—
+7K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+7K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+7K192578InCore TMT SystemNextremity Solutions, Inc.20191—
+7K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+7K191972ARIX Wrist SystemJeil Medical Corporation20190—
+7K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+7K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+7K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+7K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+7K190231InCore® Lapidus Sterile KitsNextremity Solutions, Inc.20190—
+7K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+7K190658MIS Bunion Plating SystemCrossroads Extremity Systems, LLC20192—
+7K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+7K182621CrossFT Knotless Deep Thread Suture Anchor with Disposable DriverConmed Corporation20190—
+7K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+7K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+7K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+7K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+7K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+7K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+7K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+7K171725CuffLink Implant SystemConmed Corporation20170—
+7K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20171—
+7K162198GFS UltimateParcus Medical, LLC20168—
+7K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+7K160500Elite SPK, Compasso, Elite SPK KitNcs Lab Srl20160—
+7K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—
+7K142653G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporation, Ltd.20140—
+7K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+7K140328CMC Mini TightropeArthrex, Inc.20146—
+7K133757GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC201416—
+7K133224Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi SuturesConmed Corporation201412—
+7K132502Variax 2 SystemStryker Trauma AG201321—
+7K130431Compressyn BandDallen Medical, Inc.20134—
+7K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+7K111000Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC20114—
+7K091094Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC20097—
+8K261892ProRib Fixation SystemCosta Surgical, Inc.20260—
+8K254280F.A.S.T ScrewSteps Ortho20260—
+8K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+8K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+8K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+8K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+8K254215Arthrex Beaming SystemArthrex, Inc.20261—
+8K252246Leforte MMF SystemJeil Medical Corporation20260—
+8K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+8K254176SinefixBAAT Medical Products B.V.20260—