510(k) Report

Devices descending from K123341

52 later devices reach Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211049Tigon Medical Button SystemTigon Medical20210—
+1K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+1K191426FiberTak ButtonArthrex, Inc.20190—
+1K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+1K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+1K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+2K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+2K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+2K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+2K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+2K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+2K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+2K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+2K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+2K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+3K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+3K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+3K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+3K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+3K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+3K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+3K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+3K212739ActiFlipParcus Medical, LLC20210—
+3K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+3K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+3K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+4K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+4K243203OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorRiverpoint Medical20240—
+4K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+4K241235Arthrex TightRope IIArthrex, Inc.20243—
+4K240719OC JuggerKnot Soft AnchorRiverpoint Medical20240—
+4K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—
+4K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+4K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+4K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+4K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+5K260405FiberTape ButtonArthrex, Inc.20260—
+5K253538TeKBrace Knotless AnchorTheramicro20260—
+5K253695LigaMendRiverpoint Medical, LLC20260—
+5K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+5K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+5K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+5K243988RootMend MRRRiverpoint Medical, LLC20250—
+5K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+5K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+5K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+5K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+5K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+5K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+5K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+6K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+6K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—