510(k) Report

Devices descending from K003816

66 later devices reach Arthrex Titanium Corkscrew, 3.5 MM, Arthrex Titanium Corkscrew, 5.0 MM… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060664Fastin RC AnchorDepuy Mitek200630—
+1K052491Axya Model 6500 Axyaloop Self-Tapping Bone AnchorAxya Medical, Inc.2005921
+1K050358Artherx Corkscrew FT II Suture AnchorArthrex, Inc.200540—
+2K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+2K191300MectaLock Ti Suture AnchorMedacta International S.A.20193—
+2K130814Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company20133—
+2K110538Pro Fixation SystemSynovis Orthopedic & Woundcare20110—
+2K102143Suspension Acromioclavicular (AC) Repair SystemSuspension Orthopaedic Solutions, LLC20100—
+2K092133Arthrocare Titanium Suture Anchor, Model 22-9055,22-9055N, 22-9065, 22-9065NArthrocare Corp.20095—
+2K090075Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC200913—
+2K083268Tornier, Inc., Insite Suture AnchorsTornier, Inc.20097—
+2K082282Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co.200821—
+2K072063KFX Tissue Fixation System and AccessoriesKfx Medical200718—
+3K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+3K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+3K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+3K223582MectaLock TI Triple Loaded Suture AnchorMedacta International S.A.20232—
+3K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—
+3K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC20203—
+3K183279HEALIX Ti ANCHOR with DYNACORDMedos International SARL20191—
+3K1425744.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti…Depuy Mitek, A Johnson & Johnson Company20140—
+3K132632Tornier Insite FT Suture Anchor with NeedlesTornier, Inc.20130—
+3K122635Tornier Insite FT Biocomposite Suture AnchorTornier, Inc.20130—
+3K111000Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC20114—
+3K111631Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture Anchor, Rotator Cuff…Depuy Mitek, A Johnson & Johnson Company20111—
+3K111397Titan TI Suture Anchor SystemArthrocare Corp.20110—
+3K110773Tornier Insite FT Suture AnchorTornier, Inc.20115—
+3K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company201115—
+3K102262Arthocare Spartan Peek Suture Implant System; Punch Tap ; Extraction ToolArthrocare Corp.20102—
+3K101184Titan TI Suture Anchor System, Models 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022…Arthrocare Corp.20104—
+3K091094Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC20097—
+3K081598Suture Lock Nail Bone Anchor with White (KFX-W-200) & Blue (KFX-B-200) Fiberforce SutureKfx Medical200816—
+3K0802295.5 MM Suture Lock Bone Screw AnchorKfx Medical20080—
+4K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+4K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+4K212739ActiFlipParcus Medical, LLC20210—
+4K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+4K203794HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMedos International SARL20210—
+4K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+4K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc.20152—
+4K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc.20140—
+4K112417VariousDepuy Mitek, A Johnson & Johnson Company20120—
+4K1107815.5 / 6.5MM Spartan Peek Surture Implant with #2 Magnumwire / with Needles, Extraction…Arthrocare Corp.20110—
+4K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company20116—
+4K1101645.5MM Spartan Peek Suture Implant W/ #2 Magnum Wire, Punch Tap, Extraction ToolArthrocare Corp.20111—
+4K102326Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC20105—
+4K102162Parcus Peek CF Push-in Suture AnchorParcus Medical, LLC20100—
+5K262047Grappler Suture Anchor SystemParagon 28, Inc.20260—
+5K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+5K253538TeKBrace Knotless AnchorTheramicro20260—
+5K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+5K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+5K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+5K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+5K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+5K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas201422
+5K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+5K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek…Depuy Mitek, A Johnson & Johnson Company20141—
+5K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…Depuy Mitek, A Johnson & Johnson Company20131—
+5K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company20130—
+5K122805Parcus Draw Tight 1.8MM Single-Loaded Suture AnchorParcus Medical, LLC20131—
+5K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+6K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+6K213109Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited20220—
+6K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL20180—
+6K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—