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
+1K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.20261—
+1K240288SF Push- in AnchorSurgical Fusion Technologies GmbH20241—
+1K191242HEALIX ADVANCE SP BIOCOMPOSITE AnchorMedos International SARL20192—
+1K182941HEALIX ADVANCE SP PEEK AnchorMedos International SARL20192—
+1K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL20181—
+1K173788Arthrex Corkscrew FTArthrex, Inc.20185—
+1K170868FIXIT Threaded Anchor SystemS.B.M Sas Science For Bio Materials20172—
+1K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL20172—
+1K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc.20170—
+1K133235Threaded Peek K-WireMtp Solutions, LLC20142—
+1K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company201115—
+1K101823Arthrex Swivelock AnchorsArthrex, Inc.20111036
+1K101679Arthrex Pushlock AnchorsArthrex, Inc.201041—
+2K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC20260—
+2K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.20260—
+2K260018Arthrex FiberButtonArthrex, Inc.20260—
+2K260294SF Push-in AnchorSurgical Fusion Technologies GmbH20260—
+2K253538TeKBrace Knotless AnchorTheramicro20260—
+2K252664GMReis Suture AnchorsGM Dos Reis Industria e Comercio Ltda.20251—
+2K251145Arthrex PushLock Suture AnchorsArthrex, Inc.20252—
+2K250544Knotilus+ Biocomposite Knotless AnchorStryker Endoscopy20250—
+2K250526Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture AnchorArthrex, Inc.20250—
+2K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+2K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd.20250—
+2K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek20240—
+2K232683Knotilus+ PEEK Knotless AnchorStryker Endoscopy20232—
+2K2324922.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite…Medos International SARL20230—
+2K231787ecoFIX®Science & Bio Materials (S.B.M.) Sas20230—
+2K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+2K221099Arthrex Self-Punching PushLock Suture AnchorArthrex, Inc.20225—
+2K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+2K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+2K203493MectaLock ExtensionMedacta International S.A.20210—
+2K193377TopLock Anchor SystemFusion Orthopedics, LLC20200—
+2K2018836.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite AnchorMedos International SARL20201—
+2K193157Arthrex 3.9mm Corkscrew Suture AnchorArthrex, Inc.20191—
+2K192532Arthrex SwiveLock AnchorArthrex, Inc.201916—
+2K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+2K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+2K180759SECULOK™ Suture AnchorU&I Corporation20180—
+2K180960FIXIT / ComposiTCP Threaded Anchor SystemS.B.M. Sas Sciences For Bio Materials20181—
+2K180594Knotless SutureTak AnchorsArthrex, Inc.20181—
+2K173269KATOR Suture AnchorKator, LLC20182—
+2K173240Arthrex PushLockArthrex, Inc.20182—
+2K171299Fixone Biocomposite AnchorAju Pharm Co., Ltd.20174—
+2K160118STROPP (Single Tunnel Repair of Plantar Plate)Crossroads Extremity Systems, LLC20160—
+2K151342Arthrex SwiveLock AnchorsArthrex, Inc.201638—
+2K150648Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture…Arthrex, Inc.20154—
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K143745Arthrex Corkscrew and SwiveLock Suture AnchorsArthrex, Inc.201510—
+2K141290Helical Ridge Peek Interference ScrewMedShape, Inc.20140—
+2K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+2K131635Rotation Medical Bone Staple (RMB Staple)Rotation Medical, Inc.20133—
+2K110545Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)Smith & Nephew, Inc.201140—
+2K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company20116—
+3K262047Grappler Suture Anchor SystemParagon 28, Inc.20260—
+3K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+3K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+3K251750Trax EX AnchorTrax Surgical, Inc.20260—
+3K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+3K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.20260—
+3K253895Arthrex SwiveLock Suture Anchor, 3.5 x 10 mmArthrex, Inc.20250—
+3K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd.20250—
+3K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+3K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+3K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+3K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+3K231033CEPTRE® Knotted UHMWPE Suture PEEK AnchorHealthium Medtech Limited20240—
+3K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+3K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+3K223860Integrity™ Bone Staple Fixation SystemAnika Therapeutics, Inc.20231—
+3K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+3K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+3K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+3K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+3K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+3K213958Bioabsorbable AnchorEmbody, Inc.20220—
+3K202763Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20212—
+3K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+3K201749Arthrex SwiveLock AnchorArthrex, Inc.202015—
+3K192484Fixone Biocomposite AnchorAju Pharm Co., Ltd.20203—
+3K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+3K182736OIC Suture Anchor SystemThe Orthopaedic Implant Company20180—
+3K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+3K173845Arthrex SwiveLockArthrex, Inc.20188—
+3K181083Stryker All-PEEK Knotless Anchor SystemStryker201812
+3K171141Arthrex SwiveLock AnchorsArthrex, Inc.201729—
+3K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+3K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek…Depuy Mitek, A Johnson & Johnson Company20141—
+3K133671Iconix All Suture AnchorsStryker Corp.201425—
+3K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…Depuy Mitek, A Johnson & Johnson Company20131—
+3K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company20130—
+3K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc.201213—
+3K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+4K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.20260—
+4K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+4K242529Tigon Medical All-Suture Anchors (ASA)Tigon Medical20242—
+4K240407ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture…Stryker Endoscopy20240—
+4K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+4K230094Responsive Arthroscopy Stealth and Mini Stealth All-Suture AnchorsResponsive Arthroscopy, LLC20231—