510(k) Report

Devices descending from K971358

135 later devices reach Bio-Interference Screw, 7 MM, 8 MM, 9 MM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032830Plla Cannulated Interference ScrewAdvanced Biomaterials20040—
+1K031939Bio-Eurolig Interference ScrewFournitures Hospitalieres Industrie20040—
+1K021280Inion Hexalon Biodegradable Acl/PCL ScrewInion, Ltd.20021—
+1K993073Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025…Bionx Implants, Ltd.199916—
+1K990454Bio-Interference ScrewInnovasive Devices, Inc.1999119—
+2K060393Inion Hexalon Biodegradable Acl/PCL ScrewInion, Ltd.20060—
+2K032894Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T…Linvatec Biomaterials, Inc.200415—
+2K013572Mitek Biocryl Interference ScrewsMitek Products2002117—
+2K993975Absolute Absorbable Interference ScrewInnovasive Devices, Inc.1999118—
+3K102410Matryx Interference Screw (5.0-6.5MM)Conmed Linvatec20102—
+3K091041Rigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and Tibial 3.3MM ST…Depuy Mitek, A Johnson & Johnson Company20091—
+3K090669Rigidfix Biocryl Cross Pin KitsDepuy Mitek, A Johnson & Johnson Company20092—
+3K081390Bioactif Osteotrans Interfence ScrewTakiron Co., Ltd.20080—
+3K050468Triabsorb Composite ScrewAdvanced Biomaterials20050—
+3K052080Matryx Interference ScrewLinvatec Biomaterials, Inc.200513—
+3K032717Biocryl Rapide Interference ScrewMitek Worldwide2004107—
+3K032167Bio-Intrafix Tibial Screw and SheathMitek Worldwide200315—
+4K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company20130—
+4K123362Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company20135—
+4K122869Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company20120—
+4K120589Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company20121—
+4K112249Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company201113—
+4K103831Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809Depuy Mitek, A Johnson & Johnson Company201118—
+4K101100Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503Conmed Linvatec201052
+4K093912Arthrex Tibial GraftboltArthrex, Inc.20103—
+4K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company2008441
+4K071437Megafix-C Bioabsorbable Composite Interference Screw, Model 2870719C, 2870723C…KARL STORZ Endoscopy-America, Inc.20071—
+4K071176Modification to: Arthrex Interference ScrewArthrex, Inc.200747—
+4K063588Matryx Interference Screw, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5Conmed Linvatec Biomaterials20073—
+4K063577Femoral Intrafix Screw and SheathJohnson & Johnson Company20077—
+4K060830Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company2006103—
+5K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+5K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy Mitek20241—
+5K203335MectaScrew ExtensionMedacta International S.A.20220—
+5K183501Parcus Twist AP Suture AnchorsParcus Medical, LLC20192—
+5K180759SECULOK™ Suture AnchorU&I Corporation20180—
+5K180662Arthrex FastThread Interference ScrewArthrex, Inc.20183—
+5K171299Fixone Biocomposite AnchorAju Pharm Co., Ltd.20174—
+5K170639HEALIX ADVANCE Anchor with PERMATAPE SutureMedos International SARL20171—
+5K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20172—
+5K161174Nanova Interference ScrewNanova Biomaterials, Inc.20160—
+5K160804INTRAFIX (TM) Advance Tibial Fastener SystemMedos International SARL20160—
+5K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL20162—
+5K151342Arthrex SwiveLock AnchorsArthrex, Inc.201638—
+5K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+5K130917Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company201392
+5K130539Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company20134—
+5K1221236-8MM X 30 MM Intrafix Peek Tapered Screw 7-9MM X 30MM Intrafix Peek Tapered Screw…Depuy Mitek, Inc., A Johnson and Johnson Company20125—
+5K121890Genesys Pressft Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec20120—
+5K120540BioboltArthrex, Inc.20120—
+5K120078Healix Advance BR AnchorDepuy Mitek Inc., Johnson and Johnson Company20129—
+5K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+5K110123PCL TightropeArthrex, Inc.20118—
+5K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company20116—
+5K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company201115—
+5K103060Arthrex Tibial GraftboltArthrex, Inc.20112—
+5K102443Intrafix Tibial SheathDepuy Mitek, A Johnson & Johnson Company20100—
+5K100012Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS…Depuy Mitek, A Johnson & Johnson Company201024—
+5K092998Conmed Linvatec Intercept ImplantLinvatec Corp.20090—
+5K090124Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814Depuy Mitek, A Johnson & Johnson Company2009252
+6K253130Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+6K252022OSSIOfiber® Interference ScrewOSSIO, Ltd.20250—
+6K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+6K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+6K232513X-Twist Biocomposite Suture AnchorParcus Medical20230—
+6K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.20226—
+6K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+6K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+6K202535Arthrex FastThread Interference ScrewArthrex, Inc.20202—
+6K192484Fixone Biocomposite AnchorAju Pharm Co., Ltd.20203—
+6K192824Parcus Knotless AP Suture AnchorsParcus Medical, LLC20190—
+6K191483HEALIX ADVANCE Anchor with DYNA+TAPE SuturesMedos International SARL20190—
+6K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+6K173845Arthrex SwiveLockArthrex, Inc.20188—
+6K181083Stryker All-PEEK Knotless Anchor SystemStryker201812
+6K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL20181—
+6K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL20172—
+6K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20171—
+6K171141Arthrex SwiveLock AnchorsArthrex, Inc.201729—
+6K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+6K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek…Depuy Mitek, A Johnson & Johnson Company20141—
+6K1337944.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix…Depuy Mitek, A Johnson & Johnson Company20148—
+6K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…Depuy Mitek, A Johnson & Johnson Company20131—
+6K131974Healix Advance Knotless BR Anchor (6.5MM)Depuy Mitek, A Johnson & Johnson Company20133—
+6K131683Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company20133—
+7K262047Grappler Suture Anchor SystemParagon 28, Inc.20260—
+7K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+7K251680Biosteon® ScrewBiocomposites, Ltd.20260—
+7K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+7K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek20240—
+7K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+7K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+7K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+7K231857Arthrex TightRope IIArthrex, Inc.20234—
+7K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S…Healthium Medtech Limited20230—
+7K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+7K223284SutureLoc™ ImplantArthrex, Inc.20230—
+7K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+7K203523Fixone hybrid knotless anchorAju Pharm Co., Ltd.202118