510(k) Report

Devices descending from K813581

149 later devices reach Cruciate Ligament Button through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+5K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+5K160500Elite SPK, Compasso, Elite SPK KitNcs Lab Srl20160—
+5K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—
+5K133224Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi SuturesConmed Corporation201412—
+6K260405FiberTape ButtonArthrex, Inc.20260—
+6K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+6K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+6K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+6K243408TACTIX Vector Syndesmosis SystemVilex, LLC20240—
+6K243203OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorRiverpoint Medical20240—
+6K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+6K240719OC JuggerKnot Soft AnchorRiverpoint Medical20240—
+6K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+6K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+6K212739ActiFlipParcus Medical, LLC20210—
+6K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+6K202663Suture WingOsteonic Co., Ltd.20211—
+6K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+6K192709Fixone All Suture AnchorAju Pharm Co., Ltd.20203—
+6K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+6K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+6K180763CuffLink Implant System BiocompositeConmed Corporation20180—
+6K172186BioWick X Implant with DriverCayenne Medical, Inc.20174—
+6K171465Stryker Self-Punching ICONIXStryker20171—
+7K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+7K253538TeKBrace Knotless AnchorTheramicro20260—
+7K253695LigaMendRiverpoint Medical, LLC20260—
+7K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+7K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+7K243988RootMend MRRRiverpoint Medical, LLC20250—
+7K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+7K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+7K233659Suture WingOsteonic Co., Ltd.20230—
+7K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+7K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+7K222423Fixone All Suture AnchorAju Pharm Co., Ltd.202308
+7K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+7K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+7K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—
+7K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+7K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+7K183236Rotium Bioresorbable WickNanofiber Solutions, LLC20193—
+7K172921Stryker Self-Punching ICONIXStryker20170—
+8K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+8K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+8K241912BiochargeNanofiber Solutions, LLC20240—
+8K231641Rotium Bioresorbable WickNanofiber Solutions, LLC20231—
+8K201414Rotium Bioresorbable WickNanofiber Solutions, LLC20202—