510(k) Report

Devices descending from K053344

477 later devices reach Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K170639HEALIX ADVANCE Anchor with PERMATAPE SutureMedos International SARL20171—
+4K171141Arthrex SwiveLock AnchorsArthrex, Inc.201729—
+4K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+4K163440Stealth Staple SystemFirst Ray, LLC20173—
+4K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc.20160—
+4K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+4K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc.20160—
+4K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+4K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH20150—
+4K151220Dunamis Interference ScrewDunamis, LLC20150—
+4K151314CinchLock Flex Knotless Suture AnchorPivot Medical201502
+4K151230Arthrex FiberTak AnchorsArthrex, Inc.201527—
+4K150359Tensyn PlugDallen Medical, Inc.20150—
+4K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc.201501
+4K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+4K141141Kiva VCF Treatment SystemBenvenue Medical, Inc.20140—
+4K140879Biosure Healicoil PK Interference ScrewSmith & Nephew, Inc.20141—
+4K133036Apollo Suture Anchor System and Titan ScrewsAmendia, Inc.201471
+4K133671Iconix All Suture AnchorsStryker Corp.201425—
+4K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137—
+4K1325905.5MM Multifix S Knotless Fixation Device, 6.5MM Multifix S Knotless Fixation Device…ArthroCare Corporation20133—
+4K131974Healix Advance Knotless BR Anchor (6.5MM)Depuy Mitek, A Johnson & Johnson Company20133—
+4K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec201317—
+4K123240Speedlock Hip Knotless Fixation ImplantArthroCare Corporation20130—
+4K120356NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl20121—
+4K122596Arthroscopic Surgical Instruments - Interference Screw SystemsSmith & Nephew, Inc.20120—
+4K122314Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek OnlyCayenne Medical, Inc.20126—
+4K121890Genesys Pressft Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec20120—
+4K120078Healix Advance BR AnchorDepuy Mitek Inc., Johnson and Johnson Company20129—
+4K113591Cols PeekFournitures Hospitalieres Industrie20110—
+4K113299Rog Suture AnchorRog Sports Medicine, Inc.20112—
+4K112991Modified Rog Suture AnchorRog Sports Medicine, Inc.20111—
+4K1107815.5 / 6.5MM Spartan Peek Surture Implant with #2 Magnumwire / with Needles, Extraction…Arthrocare Corp.20110—
+4K110660Arthrex Biocomposite SuturetakArthrex, Inc.201164—
+4K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company20116—
+4K1101645.5MM Spartan Peek Suture Implant W/ #2 Magnum Wire, Punch Tap, Extraction ToolArthrocare Corp.20111—
+4K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company201115—
+4K100012Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS…Depuy Mitek, A Johnson & Johnson Company201024—
+4K093943Biosure Sync Tibial Fixation Device, 6MM, 8MM,10MM,12MMSmith & Nephew Inc., Endoscopy Div.20101—
+4K093228Smith & Nephew Twinfix Ultra PK Suture AnchorSmith & Nephew, Inc.200919—
+4K091094Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC20097—
+4K091093Parcus Ppek CF Interference ScrewParcus Medical, LLC20094—
+4K090124Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814Depuy Mitek, A Johnson & Johnson Company2009252
+5K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.20260—
+5K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+5K253027Anchor with Fiber Wire and Disposable InserterOrtobio S.A.20260—
+5K260317Artelon Convenience KitsInternational Life Sciences20260—
+5K260294SF Push-in AnchorSurgical Fusion Technologies GmbH20260—
+5K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260—
+5K254176SinefixBAAT Medical Products B.V.20260—
+5K253763Y-Knotless™ Flex AnchorsConmed Corporation20261—
+5K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+5K253040Aevumed FASE Suture AnchorAevumed, Inc.20253—
+5K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+5K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+5K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+5K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+5K250526Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture AnchorArthrex, Inc.20250—
+5K242529Tigon Medical All-Suture Anchors (ASA)Tigon Medical20242—
+5K243467Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)Osteonic Co., Ltd.20240—
+5K243470Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20240—
+5K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+5K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+5K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+5K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+5K241235Arthrex TightRope IIArthrex, Inc.20243—
+5K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+5K240407ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture…Stryker Endoscopy20240—
+5K240084V-STRUT® Vertebral ImplantHyprevention20240—
+5K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+5K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+5K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+5K231078All-Suture AnchorRiverpoint Medical, LLC20233—
+5K232513X-Twist Biocomposite Suture AnchorParcus Medical20230—
+5K230094Responsive Arthroscopy Stealth and Mini Stealth All-Suture AnchorsResponsive Arthroscopy, LLC20231—
+5K231787ecoFIX®Science & Bio Materials (S.B.M.) Sas20230—
+5K231326Fix2Lock (Biocomposite medial, lateral, Biocombi Self Punching)Osteonic Co., Ltd.20231—
+5K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+5K230123Apollo Knotless Suture AnchorMaruho Medical20230—
+5K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+5K221697Injection Pin (Kip (02031-02061) (03031-03061))Slk Ortho, LLC20230—
+5K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+5K223284SutureLoc™ ImplantArthrex, Inc.20230—
+5K221396Arthrex FiberTak Suture AnchorArthrex, Inc.20223—
+5K221364Mitek TIGHT-N AnchorMedos International SARL20220—
+5K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+5K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+5K203335MectaScrew ExtensionMedacta International S.A.20220—
+5K203523Fixone hybrid knotless anchorAju Pharm Co., Ltd.202118
+5K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+5K203268Arthrex FiberTak Suture AnchorArthrex, Inc.202016—
+5K202355Stryker Omega PEEK Knotless Anchor SystemStryker20200—
+5K200428Multi-Drive Interference Screw SystemNvision Biomedical Technologies, Inc.20200—
+5K202393SpineJack Expansion KitStryker Corporation20203—
+5K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+5K202569Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC20200—
+5K193606Y-Knot OneStep AnchorConmed Corporation20200—
+5K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+5K193157Arthrex 3.9mm Corkscrew Suture AnchorArthrex, Inc.20191—
+5K192824Parcus Knotless AP Suture AnchorsParcus Medical, LLC20190—