510(k) Report

Devices descending from K053344

477 later devices reach Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K231033CEPTRE® Knotted UHMWPE Suture PEEK AnchorHealthium Medtech Limited20240—
+3K233429OTS 25 (100-1)Ots Medical, Ltd.20232—
+3K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.20230—
+3K232683Knotilus+ PEEK Knotless AnchorStryker Endoscopy20232—
+3K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+3K2324922.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite…Medos International SARL20230—
+3K232340Arthrex 2.4mm Knotless Hip SutureTak® Suture AnchorArthrex, Inc.20230—
+3K231376Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)Smith & Nephew, Inc.20230—
+3K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+3K220464Tigon Medical Gryphon Anchor LineTigon Medical20231—
+3K223878Aevumed RAPID Suture AnchorsAevumed, Inc.20236—
+3K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+3K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+3K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+3K213109Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited20220—
+3K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+3K221099Arthrex Self-Punching PushLock Suture AnchorArthrex, Inc.20225—
+3K220797FootHold SystemCrossroads Extremity Systems, LLC20220—
+3K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+3K210122Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)Osteonic Co., Ltd.20210—
+3K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+3K202763Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20212—
+3K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+3K203493MectaLock ExtensionMedacta International S.A.20210—
+3K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+3K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+3K2018836.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite AnchorMedos International SARL20201—
+3K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+3K192032Fixone Biocomposite Small AnchorAju Pharm Co., Ltd.20204—
+3K191227Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20201—
+3K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+3K192532Arthrex SwiveLock AnchorArthrex, Inc.201916—
+3K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+3K182898TenoTac Soft Tissue Fixation SystemParagon 28, Inc.20191—
+3K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+3K181746MICRORAPTOR Knotless Suture AnchorSmith and Nephew, Inc.20183—
+3K181769Arthrex FiberTak Suture AnchorArthrex, Inc.201824—
+3K180759SECULOK™ Suture AnchorU&I Corporation20180—
+3K180594Knotless SutureTak AnchorsArthrex, Inc.20181—
+3K173269KATOR Suture AnchorKator, LLC20182—
+3K180118Arthrex NanoSuture AnchorArthrex, Inc.201821
+3K173240Arthrex PushLockArthrex, Inc.20182—
+3K171964LigaMetrics Suture AnchorsMortise Medical, LLC20170—
+3K171299Fixone Biocomposite AnchorAju Pharm Co., Ltd.20174—
+3K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc.20172—
+3K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc.20170—
+3K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL20162—
+3K160118STROPP (Single Tunnel Repair of Plantar Plate)Crossroads Extremity Systems, LLC20160—
+3K151342Arthrex SwiveLock AnchorsArthrex, Inc.201638—
+3K151092Arthrex Short Suture AnchorsArthrex, Inc.201612—
+3K153395OS2-C Compression StapleIn2bones Sas20167—
+3K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+3K152255BoneCam Suture AnchorsValeris Medical20151—
+3K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+3K150648Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture…Arthrex, Inc.20154—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc.20152—
+3K143092Tensyn PlugDallen Medical, Inc.20151—
+3K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+3K141290Helical Ridge Peek Interference ScrewMedShape, Inc.20140—
+3K140476Arthrex Fibertak Suture AnchorArthrex, Inc.201429—
+3K141711Pontis 3MM Suture Anchors with Ultra-High Molecular Weight Polyethylene Suture, Pontis…Pontis Orthopaeeics, LLC20140—
+3K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+3K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+3K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+3K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+3K140127Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC20141—
+3K140925Acumed Suture Anchor SystemAcumed, LLC20140—
+3K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc.20140—
+3K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial…ArthroCare Corporation20142—
+3K133858Tensyn BandDallen Medical, Inc.20143—
+3K132817Kiva VCF Treatment SystemBenvenue Medical, Inc.20149—
+3K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+3K131850Tensyn BandDallen Medical, Inc.20135—
+3K132461A.I.M. Suture AnchorAnchor Innovation Medical, Inc.20130—
+3K131769Cinchlock Knotless Suture Anchor, Nanotack Suture Anchor 1.4MMPivot Medical, Inc.2013122
+3K132632Tornier Insite FT Suture Anchor with NeedlesTornier, Inc.20130—
+3K131635Rotation Medical Bone Staple (RMB Staple)Rotation Medical, Inc.20133—
+3K131325Quattro GL Suture AnchorCayenne Medical, Inc.20130—
+3K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+3K131182Multifix S Knotless Fixation DeviceArthocare Corporation20139—
+3K131683Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company20133—
+3K130917Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company201392
+3K130458Knotless Fibertak Suture AnchorArthrex, Inc.20132—
+3K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc.20134—
+3K122059All-Suture Anchor Twist Drill for All-Suture Anchors Inline Drill Guide for All-Suture…Smith & Nephew, Inc.201316
+3K130351Nanotack Suture Anchor 1.4MM with Flex InserterPivot Medical, Inc.20130—
+3K123651Cinchlock Knotless Suture AnchorPivot Medical20130—
+3K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+3K121356Micro/Mini N-PK (H) Bone AnchorAnulex Technologies, Inc.20120—
+3K121354Micro/Mini N-PK (F) Bone AnchorAnulex Technologies, Inc.20120—
+3K120943Speedlock Hip Knotless Fixation Implant Speedlock Hip Drill Speedlock Hip Guide Crown…ArthroCare Corporation20121—
+3K120509Stryker All Suture AnchorsStryker201227—
+3K113297Knotilus Anchor SystemT.A.G. Medical Products Corporation, Ltd.20123—
+3K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc.201213—
+3K112960Labralink Suture Anchor with Inserter, 2.9MM Per-Loaded with One (1) and (2) #2 Uhmwpe…Cayenne Medical, Inc.20121—
+3K111716Knotless Suture Fixation SystemCore Essence Orthopaedics20110—
+3K112965Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec201196
+3K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec201129—
+3K111590Rog Suture Anchor, Rog Knotless Suture AnchorRog Sports Medicine, Inc.20115—