510(k) Report

Devices descending from K984320

103 later devices reach Bioabsorbable Interference Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122596Arthroscopic Surgical Instruments - Interference Screw SystemsSmith & Nephew, Inc.20120—
+1K992396Biorci ScrewSmith & Nephew Endoscopy, Inc.200086—
+1K993073Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025…Bionx Implants, Ltd.199916—
+2K143172ACL SMART SystemSmith & Nephew, Inc.20150—
+2K051310PLC ScrewSmith & Nephew, Inc.20057124
+2K040542Smith & Nephew GTS Sleeve and GTS Tapered ScrewSmith & Nephew, Inc.20043—
+2K031939Bio-Eurolig Interference ScrewFournitures Hospitalieres Industrie20040—
+2K032894Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T…Linvatec Biomaterials, Inc.200415—
+2K032224Biorci ScrewSmith & Nephew, Inc.200316—
+3K230655PEEK RCI Screw; Bio-Composite Screw; SignaLoc ScrewSignature Orthopaedics Pty, Ltd.20230—
+3K193497Fixone Biocomposite Interference ScrewAju Pharm Co., Ltd.202118
+3K161174Nanova Interference ScrewNanova Biomaterials, Inc.20160—
+3K102410Matryx Interference Screw (5.0-6.5MM)Conmed Linvatec20102—
+3K093943Biosure Sync Tibial Fixation Device, 6MM, 8MM,10MM,12MMSmith & Nephew Inc., Endoscopy Div.20101—
+3K083619Parcus Tintanium Interference Screw, Models: 10001-10012, 10014-10016, 10018-10020Parcus Medical, LLC20097—
+3K080358Plla, HA ScrewSmith & Nephew Inc., Endoscopy Div.2008222
+3K071176Modification to: Arthrex Interference ScrewArthrex, Inc.200747—
+3K050468Triabsorb Composite ScrewAdvanced Biomaterials20050—
+3K052080Matryx Interference ScrewLinvatec Biomaterials, Inc.200513—
+4K230874Syntheface PEEK Interference Screw, Syntheface PEEK Screw SheathSuzhou Endophix Co., Ltd.20230—
+4K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+4K203029Auxilock Titanium Interference ScrewAuxein Medical Private Limited20210—
+4K202662Parcus Titanium Interference ScrewsParcus Medical, LLC20210—
+4K180662Arthrex FastThread Interference ScrewArthrex, Inc.20183—
+4K151342Arthrex SwiveLock AnchorsArthrex, Inc.201638—
+4K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc.201501
+4K120589Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company20121—
+4K110123PCL TightropeArthrex, Inc.20118—
+4K101100Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503Conmed Linvatec201052
+4K091093Parcus Ppek CF Interference ScrewParcus Medical, LLC20094—
+4K083635Smith & Nephew Biosure PK Interference ScrewSmith & Nephew Endoscopy, Inc.200921—
+4K071437Megafix-C Bioabsorbable Composite Interference Screw, Model 2870719C, 2870723C…KARL STORZ Endoscopy-America, Inc.20071—
+4K063588Matryx Interference Screw, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5Conmed Linvatec Biomaterials20073—
+5K253130Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+5K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+5K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.20226—
+5K203335MectaScrew ExtensionMedacta International S.A.20220—
+5K202883Sterile bone screw (PEEK ACL screw)Osteonic Co., Ltd.20200—
+5K202535Arthrex FastThread Interference ScrewArthrex, Inc.20202—
+5K190892MectaScrew PEEK Interference ScrewMedacta International S.A.20191—
+5K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+5K180573Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC20182—
+5K180759SECULOK™ Suture AnchorU&I Corporation20180—
+5K173845Arthrex SwiveLockArthrex, Inc.20188—
+5K181083Stryker All-PEEK Knotless Anchor SystemStryker201812
+5K170877Parcus SLiK Fix ScrewParcus Medical20171—
+5K171141Arthrex SwiveLock AnchorsArthrex, Inc.201729—
+5K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20172—
+5K151220Dunamis Interference ScrewDunamis, LLC20150—
+5K140879Biosure Healicoil PK Interference ScrewSmith & Nephew, Inc.20141—
+5K133036Apollo Suture Anchor System and Titan ScrewsAmendia, Inc.201471
+5K122869Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company20120—
+5K121890Genesys Pressft Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec20120—
+5K111471Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size)Medshape Solutions, Inc.201111
+5K092998Conmed Linvatec Intercept ImplantLinvatec Corp.20090—
+6K251680Biosteon® ScrewBiocomposites, Ltd.20260—
+6K252022OSSIOfiber® Interference ScrewOSSIO, Ltd.20250—
+6K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+6K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+6K231857Arthrex TightRope IIArthrex, Inc.20234—
+6K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S…Healthium Medtech Limited20230—
+6K230123Apollo Knotless Suture AnchorMaruho Medical20230—
+6K223284SutureLoc™ ImplantArthrex, Inc.20230—
+6K202355Stryker Omega PEEK Knotless Anchor SystemStryker20200—
+6K200428Multi-Drive Interference Screw SystemNvision Biomedical Technologies, Inc.20200—
+6K202569Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC20200—
+6K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+6K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+6K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+6K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+6K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20171—
+6K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+6K142230Apollo Suture Anchor System and Titan ScrewsValeris Medical201451
+6K132783Exoshape Duo Soft Tissue FastenerMedShape, Inc.20130—
+7K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+7K241235Arthrex TightRope IIArthrex, Inc.20243—
+7K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+7K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+7K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+7K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+7K192810Apollo Suture Anchor SystemValeris Medical20201—
+7K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+7K180763CuffLink Implant System BiocompositeConmed Corporation20180—
+7K152255BoneCam Suture AnchorsValeris Medical20151—
+8K260405FiberTape ButtonArthrex, Inc.20260—
+8K253538TeKBrace Knotless AnchorTheramicro20260—
+8K253695LigaMendRiverpoint Medical, LLC20260—
+8K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+8K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+8K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+8K243988RootMend MRRRiverpoint Medical, LLC20250—
+8K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+8K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+8K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+8K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+8K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+8K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+8K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+8K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—