510(k) Report

Devices descending from K082810

159 later devices reach Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K231322Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20231—
+4K223284SutureLoc™ ImplantArthrex, Inc.20230—
+4K221396Arthrex FiberTak Suture AnchorArthrex, Inc.20223—
+4K221364Mitek TIGHT-N AnchorMedos International SARL20220—
+4K203523Fixone hybrid knotless anchorAju Pharm Co., Ltd.202118
+4K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+4K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+4K202355Stryker Omega PEEK Knotless Anchor SystemStryker20200—
+4K193245Dunamis PunchTac Suture AnchorsDunamis, LLC20200—
+4K191227Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20201—
+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—
+4K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL20180—
+4K171465Stryker Self-Punching ICONIXStryker20171—
+4K170098ICONIX TT All Suture AnchorStryker20173—
+4K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.201562
+4K151201Stryker ICONIX with NeedlesStryker201510—
+5K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+5K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260—
+5K260405FiberTape ButtonArthrex, Inc.20260—
+5K253695LigaMendRiverpoint Medical, LLC20260—
+5K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical20251—
+5K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…Smith & Nephew, Inc.20250—
+5K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+5K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+5K250596Arthrex FiberTak Suture AnchorArthrex, Inc.20250—
+5K243988RootMend MRRRiverpoint Medical, LLC20250—
+5K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+5K243470Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20240—
+5K241235Arthrex TightRope IIArthrex, Inc.20243—
+5K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+5K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+5K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.20230—
+5K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+5K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+5K231278Knotless Suture AnchorRiverpoint Medical, LLC202331
+5K230892Fixone Biocomposite AnchorAju Pharm Co., Ltd.202308
+5K230433Arthrex Knotless FiberTak Suture AnchorArthrex, Inc.20230—
+5K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+5K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited20220—
+5K211322Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20210—
+5K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+5K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+5K173074ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker20185—
+5K172921Stryker Self-Punching ICONIXStryker20170—
+6K262677Iconix Knotless TRiverpoint Medical20260—
+6K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+6K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+6K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+6K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+6K243323Iconix Knotless AnchorRiverpoint Medical20240—
+6K240213Iconix Knotless AnchorRiverpoint Medical20240—
+6K231078All-Suture AnchorRiverpoint Medical, LLC20233—
+6K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+7K241577Iconix® AnchorRiverpoint Medical20240—
+7K233468Iconix AnchorRiverpoint Medical20231—
+8K252144Iconix Speed Anchor; Iconix Speed HA+ AnchorRiverpoint Medical20250—