510(k) Report

Devices descending from K003227

526 later devices reach Bio-Absorbable Corkscrew Model AR-1920B through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K113297Knotilus Anchor SystemT.A.G. Medical Products Corporation, Ltd.20123—
+3K120078Healix Advance BR AnchorDepuy Mitek Inc., Johnson and Johnson Company20129—
+3K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc.201213—
+3K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+3K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec201129—
+3K110538Pro Fixation SystemSynovis Orthopedic & Woundcare20110—
+3K110773Tornier Insite FT Suture AnchorTornier, Inc.20115—
+3K110229Rog Suture Anchor 5.5MM, 2.9MMRog Sports Medicine, Inc.20116—
+3K110123PCL TightropeArthrex, Inc.20118—
+3K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company20116—
+3K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company201115—
+3K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+3K102143Suspension Acromioclavicular (AC) Repair SystemSuspension Orthopaedic Solutions, LLC20100—
+3K101100Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503Conmed Linvatec201052
+3K100012Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS…Depuy Mitek, A Johnson & Johnson Company201024—
+3K092133Arthrocare Titanium Suture Anchor, Model 22-9055,22-9055N, 22-9065, 22-9065NArthrocare Corp.20095—
+3K092898Conmed Linvatec Presto Preloaded with One or Two #2 HI-FI SuturesConmed Linvatec20090—
+3K091763Michelangelo Bunion System - Mabs, Model: MA6000Instratek, Inc.20094—
+3K090107Mini TightropeArthrex, Inc.200921—
+3K090923Parcus Graft Fixation SystemParcus Medical, LLC200921—
+3K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp.2009561
+3K090835Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRLinvatec Corp.200910—
+3K090186Conmed Linvatec Paladin, Preloaded with Two #2 HI-FI SuturesLinvatec Corp.20090—
+3K090124Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814Depuy Mitek, A Johnson & Johnson Company2009252
+3K082384Hav-Lok Bunion Correction SystemInstratek, Inc.20085—
+3K082282Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co.200821—
+3K072291Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec200825—
+3K080335Tornier Cinch Knotless Fixation Implant SystemTornier, Inc.20087—
+3K071157Stryker Peek and Titanium Soft Eyelet AnchorsStryker Endoscopy2007125
+3K071978Mini Tightrope FT Repair KitArthrex, Inc.200722—
+3K070758Stryker Peek Zip Suture AnchorStryker Endoscopy20072—
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K260761APTUS Clavicle System 2.8Medartis AG20260—
+4K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+4K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+4K254306Aevumed FENIX Suture AnchorAevumed, Inc.20260—
+4K260004Aevumed PROTEKT Suture AnchorAevumed, Inc.20262—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K250095All-Suture Dual Anchor SystemSuturetech, Inc.20250—
+4K252022OSSIOfiber® Interference ScrewOSSIO, Ltd.20250—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+4K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd.20250—
+4K250526Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture AnchorArthrex, Inc.20250—
+4K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+4K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+4K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+4K241995HyperFlex™ Bunion Correction SystemFootbridge Medical20241—
+4K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+4K230546SignexOsteonic Co., Ltd.20242—
+4K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+4K232513X-Twist Biocomposite Suture AnchorParcus Medical20230—
+4K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+4K220966SinefixBAAT Medical Products B.V.20231—
+4K222589Flexible Suturing System with Anchors (FSSA)Integrity Orthopaedics, Inc.20230—
+4K213110AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In AnchorAuxein Medical Private Limited20220—
+4K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.20226—
+4K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+4K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+4K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+4K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+4K203523Fixone hybrid knotless anchorAju Pharm Co., Ltd.202118
+4K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+4K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+4K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+4K210498Betta Link Knotless Implant SystemT.A.G. Medical Products Corporation, Ltd.202101
+4K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—
+4K202535Arthrex FastThread Interference ScrewArthrex, Inc.20202—
+4K202178VersaLoop Anchor SystemT.A.G. Medical Products Corporation, Ltd.20200—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K192949Flower Suture Anchor SetFlower Orthopedics Corporation20200—
+4K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+4K200226RetroFixRetrofix Screws, LLC20200—
+4K193245Dunamis PunchTac Suture AnchorsDunamis, LLC20200—
+4K193157Arthrex 3.9mm Corkscrew Suture AnchorArthrex, Inc.20191—
+4K191972ARIX Wrist SystemJeil Medical Corporation20190—
+4K192824Parcus Knotless AP Suture AnchorsParcus Medical, LLC20190—
+4K191483HEALIX ADVANCE Anchor with DYNA+TAPE SuturesMedos International SARL20190—
+4K183094CyclaPlex Correction SystemCycla Orthopedics, Ltd.20190—
+4K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2Conmed Corporation20190—
+4K183279HEALIX Ti ANCHOR with DYNACORDMedos International SARL20191—
+4K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+4K1811202.8 mm/3.3 mm PopLok Suture AnchorsConmed Corporation20180—
+4K182446TruShot with Y-Knot All-Suture AnchorConmed Corporation20180—
+4K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K180759SECULOK™ Suture AnchorU&I Corporation20180—
+4K173845Arthrex SwiveLockArthrex, Inc.20188—
+4K181083Stryker All-PEEK Knotless Anchor SystemStryker201812
+4K173269KATOR Suture AnchorKator, LLC20182—
+4K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL20181—
+4K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+4K171703PUMA SystemPanther Orthopedics, Inc.20180—
+4K173746Activmotion RangeNewclip Technics20181—
+4K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL20172—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+4K171964LigaMetrics Suture AnchorsMortise Medical, LLC20170—