510(k) Report

Devices descending from K101823

103 later devices reach Arthrex Swivelock Anchors through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC20260—
+1K260018Arthrex FiberButtonArthrex, Inc.20260—
+1K253538TeKBrace Knotless AnchorTheramicro20260—
+1K252664GMReis Suture AnchorsGM Dos Reis Industria e Comercio Ltda.20251—
+1K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+1K192532Arthrex SwiveLock AnchorArthrex, Inc.201916—
+1K173269KATOR Suture AnchorKator, LLC20182—
+1K151342Arthrex SwiveLock AnchorsArthrex, Inc.201638—
+1K150648Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture…Arthrex, Inc.20154—
+1K143745Arthrex Corkscrew and SwiveLock Suture AnchorsArthrex, Inc.201510—
+1K141290Helical Ridge Peek Interference ScrewMedShape, Inc.20140—
+1K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+1K131635Rotation Medical Bone Staple (RMB Staple)Rotation Medical, Inc.20133—
+1K110545Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)Smith & Nephew, Inc.201140—
+2K251750Trax EX AnchorTrax Surgical, Inc.20260—
+2K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+2K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.20260—
+2K253895Arthrex SwiveLock Suture Anchor, 3.5 x 10 mmArthrex, Inc.20250—
+2K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd.20250—
+2K231033CEPTRE® Knotted UHMWPE Suture PEEK AnchorHealthium Medtech Limited20240—
+2K223860Integrity™ Bone Staple Fixation SystemAnika Therapeutics, Inc.20231—
+2K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+2K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+2K213958Bioabsorbable AnchorEmbody, Inc.20220—
+2K202763Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20212—
+2K201749Arthrex SwiveLock AnchorArthrex, Inc.202015—
+2K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+2K182736OIC Suture Anchor SystemThe Orthopaedic Implant Company20180—
+2K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+2K173845Arthrex SwiveLockArthrex, Inc.20188—
+2K181083Stryker All-PEEK Knotless Anchor SystemStryker201812
+2K171141Arthrex SwiveLock AnchorsArthrex, Inc.201729—
+2K133671Iconix All Suture AnchorsStryker Corp.201425—
+2K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc.201213—
+3K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.20260—
+3K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+3K242529Tigon Medical All-Suture Anchors (ASA)Tigon Medical20242—
+3K240407ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture…Stryker Endoscopy20240—
+3K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+3K230094Responsive Arthroscopy Stealth and Mini Stealth All-Suture AnchorsResponsive Arthroscopy, LLC20231—
+3K231322Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20231—
+3K223284SutureLoc™ ImplantArthrex, Inc.20230—
+3K221396Arthrex FiberTak Suture AnchorArthrex, Inc.20223—
+3K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+3K221364Mitek TIGHT-N AnchorMedos International SARL20220—
+3K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+3K202355Stryker Omega PEEK Knotless Anchor SystemStryker20200—
+3K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+3K193245Dunamis PunchTac Suture AnchorsDunamis, LLC20200—
+3K191227Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20201—
+3K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+3K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+3K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+3K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+3K171465Stryker Self-Punching ICONIXStryker20171—
+3K170098ICONIX TT All Suture AnchorStryker20173—
+3K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.201562
+3K151201Stryker ICONIX with NeedlesStryker201510—
+4K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+4K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260—
+4K260405FiberTape ButtonArthrex, Inc.20260—
+4K253695LigaMendRiverpoint Medical, LLC20260—
+4K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical20251—
+4K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+4K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…Smith & Nephew, Inc.20250—
+4K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+4K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+4K250596Arthrex FiberTak Suture AnchorArthrex, Inc.20250—
+4K243988RootMend MRRRiverpoint Medical, LLC20250—
+4K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd.20250—
+4K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+4K243470Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20240—
+4K241235Arthrex TightRope IIArthrex, Inc.20243—
+4K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+4K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+4K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.20230—
+4K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+4K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+4K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+4K231278Knotless Suture AnchorRiverpoint Medical, LLC202331
+4K230433Arthrex Knotless FiberTak Suture AnchorArthrex, Inc.20230—
+4K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+4K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited20220—
+4K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+4K211322Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20210—
+4K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+4K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+4K173074ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker20185—
+4K172921Stryker Self-Punching ICONIXStryker20170—
+5K262677Iconix Knotless TRiverpoint Medical20260—
+5K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+5K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+5K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+5K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+5K243323Iconix Knotless AnchorRiverpoint Medical20240—
+5K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+5K240213Iconix Knotless AnchorRiverpoint Medical20240—
+5K231078All-Suture AnchorRiverpoint Medical, LLC20233—
+5K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+6K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—