510(k) Report

Devices descending from K061863

283 later devices reach Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.20261—
+1K251145Arthrex PushLock Suture AnchorsArthrex, Inc.20252—
+1K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+1K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+1K192949Flower Suture Anchor SetFlower Orthopedics Corporation20200—
+1K191242HEALIX ADVANCE SP BIOCOMPOSITE AnchorMedos International SARL20192—
+1K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+1K190474MectaLock PEEK Suture AnchorMedacta International S.A.20190—
+1K182941HEALIX ADVANCE SP PEEK AnchorMedos International SARL20192—
+1K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL20181—
+1K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL20172—
+1K153585Flip Button Suture AnchorFirst Ray, LLC20161—
+1K143745Arthrex Corkscrew and SwiveLock Suture AnchorsArthrex, Inc.201510—
+1K140855Arthrex Suturetak Suture AnchorsArthrex, Inc.201463—
+1K133235Threaded Peek K-WireMtp Solutions, LLC20142—
+1K133469Acumed Suture Anchor SystemAcumed, LLC20142—
+1K133229Titanium Suture AnchorMtp Solutions, LLC20142—
+1K130539Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company20134—
+1K122635Tornier Insite FT Biocomposite Suture AnchorTornier, Inc.20130—
+1K120155Arthrex Knotless Suturetak AnchorArthrex, Inc.20124—
+1K112814CuffinkCayenne Medical, Inc.20120—
+1K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+1K112249Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company201113—
+1K112237Microsuture AnchorsArthrex, Inc.201177—
+1K110229Rog Suture Anchor 5.5MM, 2.9MMRog Sports Medicine, Inc.20116—
+1K101823Arthrex Swivelock AnchorsArthrex, Inc.20111036
+1K101679Arthrex Pushlock AnchorsArthrex, Inc.201041—
+1K092133Arthrocare Titanium Suture Anchor, Model 22-9055,22-9055N, 22-9065, 22-9065NArthrocare Corp.20095—
+1K090835Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRLinvatec Corp.200910—
+1K081893Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500Arthrocare Corp.200816—
+1K0815112.0 PK Suture Anchor T, 2.0 PK Suture Anchor SSmith & Nephew, Inc.20083—
+1K072291Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec200825—
+1K070882Stryker Peek Twinloop TacStryker Endoscopy200735—
+1K071177Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak…Arthrex, Inc.2007227—
+2K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC20260—
+2K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+2K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.20260—
+2K260018Arthrex FiberButtonArthrex, Inc.20260—
+2K253538TeKBrace Knotless AnchorTheramicro20260—
+2K252664GMReis Suture AnchorsGM Dos Reis Industria e Comercio Ltda.20251—
+2K250544Knotilus+ Biocomposite Knotless AnchorStryker Endoscopy20250—
+2K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd.20250—
+2K241695Extremity All Suture SystemField Orthopaedics20240—
+2K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek20240—
+2K231033CEPTRE® Knotted UHMWPE Suture PEEK AnchorHealthium Medtech Limited20240—
+2K232683Knotilus+ PEEK Knotless AnchorStryker Endoscopy20232—
+2K2324922.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite…Medos International SARL20230—
+2K232340Arthrex 2.4mm Knotless Hip SutureTak® Suture AnchorArthrex, Inc.20230—
+2K223878Aevumed RAPID Suture AnchorsAevumed, Inc.20236—
+2K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+2K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+2K221099Arthrex Self-Punching PushLock Suture AnchorArthrex, Inc.20225—
+2K220797FootHold SystemCrossroads Extremity Systems, LLC20220—
+2K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+2K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+2K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+2K202763Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20212—
+2K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+2K203493MectaLock ExtensionMedacta International S.A.20210—
+2K193377TopLock Anchor SystemFusion Orthopedics, LLC20200—
+2K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+2K2018836.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite AnchorMedos International SARL20201—
+2K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+2K192032Fixone Biocomposite Small AnchorAju Pharm Co., Ltd.20204—
+2K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+2K192532Arthrex SwiveLock AnchorArthrex, Inc.201916—
+2K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+2K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+2K181769Arthrex FiberTak Suture AnchorArthrex, Inc.201824—
+2K180759SECULOK™ Suture AnchorU&I Corporation20180—
+2K180594Knotless SutureTak AnchorsArthrex, Inc.20181—
+2K173269KATOR Suture AnchorKator, LLC20182—
+2K180118Arthrex NanoSuture AnchorArthrex, Inc.201821
+2K173240Arthrex PushLockArthrex, Inc.20182—
+2K171964LigaMetrics Suture AnchorsMortise Medical, LLC20170—
+2K171299Fixone Biocomposite AnchorAju Pharm Co., Ltd.20174—
+2K162429ZipE Knotless Tissue Repair and Attachment DevicesZiptek, LLC20175—
+2K160118STROPP (Single Tunnel Repair of Plantar Plate)Crossroads Extremity Systems, LLC20160—
+2K151342Arthrex SwiveLock AnchorsArthrex, Inc.201638—
+2K151092Arthrex Short Suture AnchorsArthrex, Inc.201612—
+2K152255BoneCam Suture AnchorsValeris Medical20151—
+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—
+2K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc.20152—
+2K141290Helical Ridge Peek Interference ScrewMedShape, Inc.20140—
+2K140476Arthrex Fibertak Suture AnchorArthrex, Inc.201429—
+2K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+2K140925Acumed Suture Anchor SystemAcumed, LLC20140—
+2K131635Rotation Medical Bone Staple (RMB Staple)Rotation Medical, Inc.20133—
+2K131182Multifix S Knotless Fixation DeviceArthocare Corporation20139—
+2K131683Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company20133—
+2K130917Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company201392
+2K130458Knotless Fibertak Suture AnchorArthrex, Inc.20132—
+2K120509Stryker All Suture AnchorsStryker201227—
+2K113297Knotilus Anchor SystemT.A.G. Medical Products Corporation, Ltd.20123—
+2K112965Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec201196
+2K111590Rog Suture Anchor, Rog Knotless Suture AnchorRog Sports Medicine, Inc.20115—
+2K111397Titan TI Suture Anchor SystemArthrocare Corp.20110—
+2K110545Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)Smith & Nephew, Inc.201140—
+2K102262Arthocare Spartan Peek Suture Implant System; Punch Tap ; Extraction ToolArthrocare Corp.20102—