510(k) Report

Devices descending from K961555

584 later devices reach Acufex Tag Bioabsorbable Anchors through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K080862Sonicweld RX (Resorb-X)KLS-Martin L.P.20084—
+4K072291Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec200825—
+4K071586Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division20071211
+4K070882Stryker Peek Twinloop TacStryker Endoscopy200735—
+4K070293Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc.200710—
+4K071177Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak…Arthrex, Inc.2007227—
+4K070908Smith & Nephew Kinsa RC Suture AnchorSmith & Nephew Inc., Endoscopy Division200760—
+4K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20073—
+4K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P.200665—
+4K051236Resorb-X SFKLS-Martin L.P.20056—
+4K012486Osteomed Bioresorbable Fixation SystemOsteomed Corp.20020—
+5K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC20260—
+5K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+5K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.20260—
+5K260018Arthrex FiberButtonArthrex, Inc.20260—
+5K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+5K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+5K253538TeKBrace Knotless AnchorTheramicro20260—
+5K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…KLS-Martin L.P.20250—
+5K252664GMReis Suture AnchorsGM Dos Reis Industria e Comercio Ltda.20251—
+5K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…Smith & Nephew, Inc.20250—
+5K250544Knotilus+ Biocomposite Knotless AnchorStryker Endoscopy20250—
+5K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd.20250—
+5K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd.20250—
+5K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+5K241695Extremity All Suture SystemField Orthopaedics20240—
+5K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek20240—
+5K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+5K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.20241—
+5K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy Mitek20241—
+5K233730Footprint Mini PK, 3.5mm Suture AnchorSmith & Nephew20240—
+5K231033CEPTRE® Knotted UHMWPE Suture PEEK AnchorHealthium Medtech Limited20240—
+5K233429OTS 25 (100-1)Ots Medical, Ltd.20232—
+5K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.20230—
+5K232683Knotilus+ PEEK Knotless AnchorStryker Endoscopy20232—
+5K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+5K2324922.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite…Medos International SARL20230—
+5K232340Arthrex 2.4mm Knotless Hip SutureTak® Suture AnchorArthrex, Inc.20230—
+5K231376Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)Smith & Nephew, Inc.20230—
+5K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+5K220464Tigon Medical Gryphon Anchor LineTigon Medical20231—
+5K223878Aevumed RAPID Suture AnchorsAevumed, Inc.20236—
+5K222589Flexible Suturing System with Anchors (FSSA)Integrity Orthopaedics, Inc.20230—
+5K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+5K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+5K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+5K221099Arthrex Self-Punching PushLock Suture AnchorArthrex, Inc.20225—
+5K220797FootHold SystemCrossroads Extremity Systems, LLC20220—
+5K213777Stryker Resorbable Fixation SystemStryker Leibinger Micro Implants20222—
+5K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+5K210122Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)Osteonic Co., Ltd.20210—
+5K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+5K202763Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20212—
+5K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+5K203493MectaLock ExtensionMedacta International S.A.20210—
+5K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+5K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+5K2018836.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite AnchorMedos International SARL20201—
+5K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+5K192032Fixone Biocomposite Small AnchorAju Pharm Co., Ltd.20204—
+5K191227Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20201—
+5K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+5K192532Arthrex SwiveLock AnchorArthrex, Inc.201916—
+5K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+5K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2Conmed Corporation20190—
+5K182898TenoTac Soft Tissue Fixation SystemParagon 28, Inc.20191—
+5K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+5K1811202.8 mm/3.3 mm PopLok Suture AnchorsConmed Corporation20180—
+5K182446TruShot with Y-Knot All-Suture AnchorConmed Corporation20180—
+5K181746MICRORAPTOR Knotless Suture AnchorSmith and Nephew, Inc.20183—
+5K181769Arthrex FiberTak Suture AnchorArthrex, Inc.201824—
+5K180759SECULOK™ Suture AnchorU&I Corporation20180—
+5K180594Knotless SutureTak AnchorsArthrex, Inc.20181—
+5K173269KATOR Suture AnchorKator, LLC20182—
+5K180118Arthrex NanoSuture AnchorArthrex, Inc.201821
+5K173240Arthrex PushLockArthrex, Inc.20182—
+5K171964LigaMetrics Suture AnchorsMortise Medical, LLC20170—
+5K171299Fixone Biocomposite AnchorAju Pharm Co., Ltd.20174—
+5K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc.20172—
+5K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20172—
+5K163258CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation20179—
+5K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL20162—
+5K160118STROPP (Single Tunnel Repair of Plantar Plate)Crossroads Extremity Systems, LLC20160—
+5K151342Arthrex SwiveLock AnchorsArthrex, Inc.201638—
+5K151092Arthrex Short Suture AnchorsArthrex, Inc.201612—
+5K153395OS2-C Compression StapleIn2bones Sas20167—
+5K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+5K152255BoneCam Suture AnchorsValeris Medical20151—
+5K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+5K150648Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture…Arthrex, Inc.20154—
+5K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc.20152—
+5K141385Depuy Synthes Injectable Polymer System (Ips)Depuy Synthes Companies of Johnson & Johnson201501
+5K143092Tensyn PlugDallen Medical, Inc.20151—
+5K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+5K141290Helical Ridge Peek Interference ScrewMedShape, Inc.20140—
+5K140476Arthrex Fibertak Suture AnchorArthrex, Inc.201429—
+5K141711Pontis 3MM Suture Anchors with Ultra-High Molecular Weight Polyethylene Suture, Pontis…Pontis Orthopaeeics, LLC20140—
+5K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+5K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+5K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—