510(k) Report

Devices descending from K071704

142 later devices reach Sleeve and Button Soft Tissue Devices through their predicates, nearest generation first.

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