510(k) Report

Devices descending from K961555

584 later devices reach Acufex Tag Bioabsorbable Anchors through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+7K253027Anchor with Fiber Wire and Disposable InserterOrtobio S.A.20260—
+7K260317Artelon Convenience KitsInternational Life Sciences20260—
+7K260294SF Push-in AnchorSurgical Fusion Technologies GmbH20260—
+7K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260—
+7K254176SinefixBAAT Medical Products B.V.20260—
+7K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+7K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+7K253040Aevumed FASE Suture AnchorAevumed, Inc.20253—
+7K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+7K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+7K251296The Acumed Wrist Fixation SystemAcumed, LLC202501
+7K251530CONMED Argo Knotless® AnchorConmed Corporation20250—
+7K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+7K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+7K250526Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture AnchorArthrex, Inc.20250—
+7K242529Tigon Medical All-Suture Anchors (ASA)Tigon Medical20242—
+7K243467Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)Osteonic Co., Ltd.20240—
+7K243470Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20240—
+7K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+7K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+7K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+7K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+7K241235Arthrex TightRope IIArthrex, Inc.20243—
+7K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+7K240407ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture…Stryker Endoscopy20240—
+7K240090Argo Knotless GENESYS AnchorConmed Corporation20242—
+7K240084V-STRUT® Vertebral ImplantHyprevention20240—
+7K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.20240—
+7K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+7K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+7K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+7K231078All-Suture AnchorRiverpoint Medical, LLC20233—
+7K232513X-Twist Biocomposite Suture AnchorParcus Medical20230—
+7K230094Responsive Arthroscopy Stealth and Mini Stealth All-Suture AnchorsResponsive Arthroscopy, LLC20231—
+7K231787ecoFIX®Science & Bio Materials (S.B.M.) Sas20230—
+7K231326Fix2Lock (Biocomposite medial, lateral, Biocombi Self Punching)Osteonic Co., Ltd.20231—
+7K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+7K230123Apollo Knotless Suture AnchorMaruho Medical20230—
+7K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+7K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.20233—
+7K221938KLS Martin Pure Pectus SystemKLS Martin L.P.20236—
+7K221697Injection Pin (Kip (02031-02061) (03031-03061))Slk Ortho, LLC20230—
+7K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+7K223284SutureLoc™ ImplantArthrex, Inc.20230—
+7K221396Arthrex FiberTak Suture AnchorArthrex, Inc.20223—
+7K221364Mitek TIGHT-N AnchorMedos International SARL20220—
+7K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+7K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+7K203335MectaScrew ExtensionMedacta International S.A.20220—
+7K203523Fixone hybrid knotless anchorAju Pharm Co., Ltd.202118
+7K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+7K202663Suture WingOsteonic Co., Ltd.20211—
+7K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+7K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices202139—
+7K192709Fixone All Suture AnchorAju Pharm Co., Ltd.20203—
+7K203268Arthrex FiberTak Suture AnchorArthrex, Inc.202016—
+7K202355Stryker Omega PEEK Knotless Anchor SystemStryker20200—
+7K200428Multi-Drive Interference Screw SystemNvision Biomedical Technologies, Inc.20200—
+7K202393SpineJack Expansion KitStryker Corporation20203—
+7K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+7K202569Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC20200—
+7K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+7K193157Arthrex 3.9mm Corkscrew Suture AnchorArthrex, Inc.20191—
+7K192824Parcus Knotless AP Suture AnchorsParcus Medical, LLC20190—
+7K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+7K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+7K190915OsteoFab Suture AnchorsOxford Performance Materials, Inc.20190—
+7K191483HEALIX ADVANCE Anchor with DYNA+TAPE SuturesMedos International SARL20190—
+7K180960FIXIT / ComposiTCP Threaded Anchor SystemS.B.M. Sas Sciences For Bio Materials20181—
+7K180763CuffLink Implant System BiocompositeConmed Corporation20180—
+7K172186BioWick X Implant with DriverCayenne Medical, Inc.20174—
+7K171465Stryker Self-Punching ICONIXStryker20171—
+7K170877Parcus SLiK Fix ScrewParcus Medical20171—
+7K170098ICONIX TT All Suture AnchorStryker20173—
+7K160319FiberTak DRArthrex, Inc.20160—
+7K151201Stryker ICONIX with NeedlesStryker201510—
+7K143392Quattro Bolt Tenodesis ScrewCayenne Medical, Inc.20150—
+7K142230Apollo Suture Anchor System and Titan ScrewsValeris Medical201451
+7K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek…Depuy Mitek, A Johnson & Johnson Company20141—
+7K140604Multifix S Knotless Fixation SystemArthroCare Corporation20142—
+7K1337944.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix…Depuy Mitek, A Johnson & Johnson Company20148—
+7K130431Compressyn BandDallen Medical, Inc.20134—
+7K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company20130—
+7K111471Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size)Medshape Solutions, Inc.201111
+7K100159Smith and Nephew Twinfix Ultra TI Suture AnchorSmith & Nephew Inc., Endoscopy Div.2010174
+8K261892ProRib Fixation SystemCosta Surgical, Inc.20260—
+8K262047Grappler Suture Anchor SystemParagon 28, Inc.20260—
+8K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+8K254229Arthrex Nano FiberTak Suture AnchorArthrex, Inc.20260—
+8K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+8K253660KLS Martin Pure Pectus SystemKLS-Martin L.P.20260—
+8K260004Aevumed PROTEKT Suture AnchorAevumed, Inc.20262—
+8K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+8K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+8K250596Arthrex FiberTak Suture AnchorArthrex, Inc.20250—
+8K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+8K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20252—
+8K244025Argo Knotless GENESYS AnchorConmed Corporation20251—
+8K243408TACTIX Vector Syndesmosis SystemVilex, LLC20240—