510(k) Report

Devices descending from K052607

95 later devices reach Arthrex Interference Screw-Rounded Head Screws, Full Threaded Screws, Sheathed… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230595OsteoCentric ACL Fixation SystemOsteoCentric Technologies20230—
+1K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial…ArthroCare Corporation20142—
+1K062466Arthrex Interference ScrewArthrex, Inc.200693—
+2K180670ICONN Campbell Interference ScrewIconn Orthopedics, LLC20180—
+2K180573Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC20182—
+2K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+2K130217Orthopediatrics Acl Reconstructive SystemOrthoPediatrics Corp.201343
+2K112040Arthrex Biocomposite TransfixArthrex, Inc.20110—
+2K111471Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size)Medshape Solutions, Inc.201111
+2K101808Shapeloc-CL (Cruciate Ligament) Soft Tissie Fastner, Shapeloc-ST (Tenodesis) Soft Tissue…Medshape Solutions20104—
+2K092998Conmed Linvatec Intercept ImplantLinvatec Corp.20090—
+2K083619Parcus Tintanium Interference Screw, Models: 10001-10012, 10014-10016, 10018-10020Parcus Medical, LLC20097—
+2K083635Smith & Nephew Biosure PK Interference ScrewSmith & Nephew Endoscopy, Inc.200921—
+2K083226Smith & Nephew Peek Interference ScrewSmith & Nephew Endoscopy, Inc.20099—
+2K071176Modification to: Arthrex Interference ScrewArthrex, Inc.200747—
+2K071464Inion Hexalon Biodegradable Acl/PCL ScrewInion OY20071—
+3K253130Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K230874Syntheface PEEK Interference Screw, Syntheface PEEK Screw SheathSuzhou Endophix Co., Ltd.20230—
+3K230655PEEK RCI Screw; Bio-Composite Screw; SignaLoc ScrewSignature Orthopaedics Pty, Ltd.20230—
+3K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, Inc.20230—
+3K212197WasherCap Fixation SystemAbanza Tecnomed S.L20223—
+3K203029Auxilock Titanium Interference ScrewAuxein Medical Private Limited20210—
+3K202662Parcus Titanium Interference ScrewsParcus Medical, LLC20210—
+3K202883Sterile bone screw (PEEK ACL screw)Osteonic Co., Ltd.20200—
+3K200428Multi-Drive Interference Screw SystemNvision Biomedical Technologies, Inc.20200—
+3K202569Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC20200—
+3K190892MectaScrew PEEK Interference ScrewMedacta International S.A.20191—
+3K180662Arthrex FastThread Interference ScrewArthrex, Inc.20183—
+3K151342Arthrex SwiveLock AnchorsArthrex, Inc.201638—
+3K151220Dunamis Interference ScrewDunamis, LLC20150—
+3K140879Biosure Healicoil PK Interference ScrewSmith & Nephew, Inc.20141—
+3K133036Apollo Suture Anchor System and Titan ScrewsAmendia, Inc.201471
+3K132783Exoshape Duo Soft Tissue FastenerMedShape, Inc.20130—
+3K130716Bioretec Activascrew InterferenceBioretec, Ltd.20130—
+3K123350Eclipse Soft Tissue FastenerMedShape, Inc.20132—
+3K122596Arthroscopic Surgical Instruments - Interference Screw SystemsSmith & Nephew, Inc.20120—
+3K113591Cols PeekFournitures Hospitalieres Industrie20110—
+3K110123PCL TightropeArthrex, Inc.20118—
+3K093943Biosure Sync Tibial Fixation Device, 6MM, 8MM,10MM,12MMSmith & Nephew Inc., Endoscopy Div.20101—
+3K091093Parcus Ppek CF Interference ScrewParcus Medical, LLC20094—
+4K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+4K250238WasherCap™ Fixation SystemAbanza Tecnomed S.L20250—
+4K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+4K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+4K230123Apollo Knotless Suture AnchorMaruho Medical20230—
+4K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.20226—
+4K203335MectaScrew ExtensionMedacta International S.A.20220—
+4K202535Arthrex FastThread Interference ScrewArthrex, Inc.20202—
+4K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+4K173845Arthrex SwiveLockArthrex, Inc.20188—
+4K181083Stryker All-PEEK Knotless Anchor SystemStryker201812
+4K170877Parcus SLiK Fix ScrewParcus Medical20171—
+4K171141Arthrex SwiveLock AnchorsArthrex, Inc.201729—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc.201501
+4K141290Helical Ridge Peek Interference ScrewMedShape, Inc.20140—
+4K142230Apollo Suture Anchor System and Titan ScrewsValeris Medical201451
+5K251680Biosteon® ScrewBiocomposites, Ltd.20260—
+5K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+5K252022OSSIOfiber® Interference ScrewOSSIO, Ltd.20250—
+5K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+5K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+5K231857Arthrex TightRope IIArthrex, Inc.20234—
+5K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S…Healthium Medtech Limited20230—
+5K223284SutureLoc™ ImplantArthrex, Inc.20230—
+5K202355Stryker Omega PEEK Knotless Anchor SystemStryker20200—
+5K192810Apollo Suture Anchor SystemValeris Medical20201—
+5K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+5K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+5K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+5K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+5K152255BoneCam Suture AnchorsValeris Medical20151—
+6K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+6K241235Arthrex TightRope IIArthrex, Inc.20243—
+6K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+6K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+6K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+6K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+6K193108Bonecam Suture AnchorValeris Medical, Inc.20200—
+6K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+7K260405FiberTape ButtonArthrex, Inc.20260—
+7K253538TeKBrace Knotless AnchorTheramicro20260—
+7K253695LigaMendRiverpoint Medical, LLC20260—
+7K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+7K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+7K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+7K243988RootMend MRRRiverpoint Medical, LLC20250—
+7K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+7K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+7K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+7K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+7K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+7K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+7K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+8K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—