510(k) Report

Devices descending from K051310

71 later devices reach PLC Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080358Plla, HA ScrewSmith & Nephew Inc., Endoscopy Div.2008222
+1K071176Modification to: Arthrex Interference ScrewArthrex, Inc.200747—
+2K180662Arthrex FastThread Interference ScrewArthrex, Inc.20183—
+2K151342Arthrex SwiveLock AnchorsArthrex, Inc.201638—
+2K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc.201501
+2K110123PCL TightropeArthrex, Inc.20118—
+2K083635Smith & Nephew Biosure PK Interference ScrewSmith & Nephew Endoscopy, Inc.200921—
+3K253130Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+3K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+3K230874Syntheface PEEK Interference Screw, Syntheface PEEK Screw SheathSuzhou Endophix Co., Ltd.20230—
+3K230655PEEK RCI Screw; Bio-Composite Screw; SignaLoc ScrewSignature Orthopaedics Pty, Ltd.20230—
+3K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.20226—
+3K202883Sterile bone screw (PEEK ACL screw)Osteonic Co., Ltd.20200—
+3K202535Arthrex FastThread Interference ScrewArthrex, Inc.20202—
+3K190892MectaScrew PEEK Interference ScrewMedacta International S.A.20191—
+3K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+3K180573Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC20182—
+3K173845Arthrex SwiveLockArthrex, Inc.20188—
+3K181083Stryker All-PEEK Knotless Anchor SystemStryker201812
+3K171141Arthrex SwiveLock AnchorsArthrex, Inc.201729—
+3K151220Dunamis Interference ScrewDunamis, LLC20150—
+3K140879Biosure Healicoil PK Interference ScrewSmith & Nephew, Inc.20141—
+3K133036Apollo Suture Anchor System and Titan ScrewsAmendia, Inc.201471
+3K122596Arthroscopic Surgical Instruments - Interference Screw SystemsSmith & Nephew, Inc.20120—
+3K093943Biosure Sync Tibial Fixation Device, 6MM, 8MM,10MM,12MMSmith & Nephew Inc., Endoscopy Div.20101—
+4K251680Biosteon® ScrewBiocomposites, Ltd.20260—
+4K252022OSSIOfiber® Interference ScrewOSSIO, Ltd.20250—
+4K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+4K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+4K231857Arthrex TightRope IIArthrex, Inc.20234—
+4K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S…Healthium Medtech Limited20230—
+4K230123Apollo Knotless Suture AnchorMaruho Medical20230—
+4K223284SutureLoc™ ImplantArthrex, Inc.20230—
+4K203335MectaScrew ExtensionMedacta International S.A.20220—
+4K202355Stryker Omega PEEK Knotless Anchor SystemStryker20200—
+4K200428Multi-Drive Interference Screw SystemNvision Biomedical Technologies, Inc.20200—
+4K202569Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC20200—
+4K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+4K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+4K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+4K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K142230Apollo Suture Anchor System and Titan ScrewsValeris Medical201451
+5K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+5K241235Arthrex TightRope IIArthrex, Inc.20243—
+5K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+5K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+5K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+5K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+5K192810Apollo Suture Anchor SystemValeris Medical20201—
+5K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+5K152255BoneCam Suture AnchorsValeris Medical20151—
+6K260405FiberTape ButtonArthrex, Inc.20260—
+6K253538TeKBrace Knotless AnchorTheramicro20260—
+6K253695LigaMendRiverpoint Medical, LLC20260—
+6K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+6K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+6K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+6K243988RootMend MRRRiverpoint Medical, LLC20250—
+6K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+6K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+6K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+6K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+6K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+6K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+6K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+6K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+6K193108Bonecam Suture AnchorValeris Medical, Inc.20200—
+7K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+7K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—