510(k) Report

Devices descending from K031685

478 later devices reach Tag Rod Bioraptor Suture Anchor 7209317, 7209318 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K241695Extremity All Suture SystemField Orthopaedics20240—
+4K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek20240—
+4K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+4K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy Mitek20241—
+4K233730Footprint Mini PK, 3.5mm Suture AnchorSmith & Nephew20240—
+4K231033CEPTRE® Knotted UHMWPE Suture PEEK AnchorHealthium Medtech Limited20240—
+4K233429OTS 25 (100-1)Ots Medical, Ltd.20232—
+4K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.20230—
+4K232683Knotilus+ PEEK Knotless AnchorStryker Endoscopy20232—
+4K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+4K2324922.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite…Medos International SARL20230—
+4K232340Arthrex 2.4mm Knotless Hip SutureTak® Suture AnchorArthrex, Inc.20230—
+4K231376Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)Smith & Nephew, Inc.20230—
+4K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+4K220464Tigon Medical Gryphon Anchor LineTigon Medical20231—
+4K223878Aevumed RAPID Suture AnchorsAevumed, Inc.20236—
+4K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+4K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+4K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+4K221099Arthrex Self-Punching PushLock Suture AnchorArthrex, Inc.20225—
+4K220797FootHold SystemCrossroads Extremity Systems, LLC20220—
+4K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+4K210122Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)Osteonic Co., Ltd.20210—
+4K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+4K202763Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20212—
+4K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+4K203493MectaLock ExtensionMedacta International S.A.20210—
+4K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+4K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+4K2018836.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite AnchorMedos International SARL20201—
+4K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+4K192032Fixone Biocomposite Small AnchorAju Pharm Co., Ltd.20204—
+4K191227Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20201—
+4K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+4K192532Arthrex SwiveLock AnchorArthrex, Inc.201916—
+4K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+4K182898TenoTac Soft Tissue Fixation SystemParagon 28, Inc.20191—
+4K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+4K181746MICRORAPTOR Knotless Suture AnchorSmith and Nephew, Inc.20183—
+4K181769Arthrex FiberTak Suture AnchorArthrex, Inc.201824—
+4K180759SECULOK™ Suture AnchorU&I Corporation20180—
+4K180594Knotless SutureTak AnchorsArthrex, Inc.20181—
+4K173269KATOR Suture AnchorKator, LLC20182—
+4K180118Arthrex NanoSuture AnchorArthrex, Inc.201821
+4K173240Arthrex PushLockArthrex, Inc.20182—
+4K171964LigaMetrics Suture AnchorsMortise Medical, LLC20170—
+4K171299Fixone Biocomposite AnchorAju Pharm Co., Ltd.20174—
+4K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc.20172—
+4K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL20162—
+4K160118STROPP (Single Tunnel Repair of Plantar Plate)Crossroads Extremity Systems, LLC20160—
+4K151342Arthrex SwiveLock AnchorsArthrex, Inc.201638—
+4K151092Arthrex Short Suture AnchorsArthrex, Inc.201612—
+4K153395OS2-C Compression StapleIn2bones Sas20167—
+4K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+4K152255BoneCam Suture AnchorsValeris Medical20151—
+4K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+4K150648Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture…Arthrex, Inc.20154—
+4K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc.20152—
+4K143092Tensyn PlugDallen Medical, Inc.20151—
+4K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+4K141290Helical Ridge Peek Interference ScrewMedShape, Inc.20140—
+4K140476Arthrex Fibertak Suture AnchorArthrex, Inc.201429—
+4K141711Pontis 3MM Suture Anchors with Ultra-High Molecular Weight Polyethylene Suture, Pontis…Pontis Orthopaeeics, LLC20140—
+4K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+4K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+4K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+4K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+4K140127Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC20141—
+4K140925Acumed Suture Anchor SystemAcumed, LLC20140—
+4K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc.20140—
+4K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial…ArthroCare Corporation20142—
+4K133858Tensyn BandDallen Medical, Inc.20143—
+4K132817Kiva VCF Treatment SystemBenvenue Medical, Inc.20149—
+4K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+4K131850Tensyn BandDallen Medical, Inc.20135—
+4K132461A.I.M. Suture AnchorAnchor Innovation Medical, Inc.20130—
+4K131769Cinchlock Knotless Suture Anchor, Nanotack Suture Anchor 1.4MMPivot Medical, Inc.2013122
+4K132632Tornier Insite FT Suture Anchor with NeedlesTornier, Inc.20130—
+4K131635Rotation Medical Bone Staple (RMB Staple)Rotation Medical, Inc.20133—
+4K131325Quattro GL Suture AnchorCayenne Medical, Inc.20130—
+4K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+4K131182Multifix S Knotless Fixation DeviceArthocare Corporation20139—
+4K131683Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company20133—
+4K130917Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company201392
+4K130458Knotless Fibertak Suture AnchorArthrex, Inc.20132—
+4K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc.20134—
+4K122059All-Suture Anchor Twist Drill for All-Suture Anchors Inline Drill Guide for All-Suture…Smith & Nephew, Inc.201316
+4K130351Nanotack Suture Anchor 1.4MM with Flex InserterPivot Medical, Inc.20130—
+4K123651Cinchlock Knotless Suture AnchorPivot Medical20130—
+4K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+4K121356Micro/Mini N-PK (H) Bone AnchorAnulex Technologies, Inc.20120—
+4K121354Micro/Mini N-PK (F) Bone AnchorAnulex Technologies, Inc.20120—
+4K120943Speedlock Hip Knotless Fixation Implant Speedlock Hip Drill Speedlock Hip Guide Crown…ArthroCare Corporation20121—
+4K120509Stryker All Suture AnchorsStryker201227—
+4K113297Knotilus Anchor SystemT.A.G. Medical Products Corporation, Ltd.20123—
+4K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc.201213—
+4K112960Labralink Suture Anchor with Inserter, 2.9MM Per-Loaded with One (1) and (2) #2 Uhmwpe…Cayenne Medical, Inc.20121—
+4K111716Knotless Suture Fixation SystemCore Essence Orthopaedics20110—
+4K112965Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec201196
+4K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec201129—