510(k) Report

Devices descending from K043337

145 later devices reach Arthrex Bio-Corkscrew FT Suture Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171299Fixone Biocomposite AnchorAju Pharm Co., Ltd.20174—
+1K070882Stryker Peek Twinloop TacStryker Endoscopy200735—
+1K061949Doubleplay Suture AnchorBiocomposites, Ltd.20060—
+1K061665Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FTArthrex, Inc.2006114—
+2K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd.20250—
+2K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+2K192484Fixone Biocomposite AnchorAju Pharm Co., Ltd.20203—
+2K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+2K181680ICONN Answer II Suture AnchorIconn Orthopedics, LLC20180—
+2K180464AEVUMED PHANTOM Suture AnchorsAevumed, Inc.20184—
+2K173788Arthrex Corkscrew FTArthrex, Inc.20185—
+2K152236KATOR Suture AnchorKator, LLC20154—
+2K120509Stryker All Suture AnchorsStryker201227—
+2K113274Footprint Ultra PK Suture AnchorSmith & Nephew, Inc.201216—
+2K113297Knotilus Anchor SystemT.A.G. Medical Products Corporation, Ltd.20123—
+2K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc.201213—
+2K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC201149—
+2K110538Pro Fixation SystemSynovis Orthopedic & Woundcare20110—
+2K092133Arthrocare Titanium Suture Anchor, Model 22-9055,22-9055N, 22-9065, 22-9065NArthrocare Corp.20095—
+2K080335Tornier Cinch Knotless Fixation Implant SystemTornier, Inc.20087—
+2K071157Stryker Peek and Titanium Soft Eyelet AnchorsStryker Endoscopy2007125
+2K070758Stryker Peek Zip Suture AnchorStryker Endoscopy20072—
+3K254306Aevumed FENIX Suture AnchorAevumed, Inc.20260—
+3K260004Aevumed PROTEKT Suture AnchorAevumed, Inc.20262—
+3K250095All-Suture Dual Anchor SystemSuturetech, Inc.20250—
+3K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd.20250—
+3K250526Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture AnchorArthrex, Inc.20250—
+3K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+3K220966SinefixBAAT Medical Products B.V.20231—
+3K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+3K203523Fixone hybrid knotless anchorAju Pharm Co., Ltd.202118
+3K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+3K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+3K210498Betta Link Knotless Implant SystemT.A.G. Medical Products Corporation, Ltd.202101
+3K202178VersaLoop Anchor SystemT.A.G. Medical Products Corporation, Ltd.20200—
+3K193245Dunamis PunchTac Suture AnchorsDunamis, LLC20200—
+3K192984APTUS Clavicle SystemMedartis AG20206—
+3K193157Arthrex 3.9mm Corkscrew Suture AnchorArthrex, Inc.20191—
+3K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+3K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+3K180759SECULOK™ Suture AnchorU&I Corporation20180—
+3K173269KATOR Suture AnchorKator, LLC20182—
+3K171964LigaMetrics Suture AnchorsMortise Medical, LLC20170—
+3K162386KATOR Suture AnchorKator, LLC20163—
+3K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.201562
+3K151201Stryker ICONIX with NeedlesStryker201510—
+3K142643Stabilynx PEEK Suture AnchorD3 Dc, LLC /Stabilynx, Inc.20140—
+3K133671Iconix All Suture AnchorsStryker Corp.201425—
+3K123579Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SLSmith & Nephew, Inc.20134—
+3K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+3K111397Titan TI Suture Anchor SystemArthrocare Corp.20110—
+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—
+3K091870Tornier, Piton Fixation Implant SystemTornier20096—
+3K080447Surgicraft Screw Fixation SystemSurgicraft, Ltd.20080—
+4K260018Arthrex FiberButtonArthrex, Inc.20260—
+4K260761APTUS Clavicle System 2.8Medartis AG20260—
+4K252635ArthroTAK Tendon Anchor KitArthroTAK, LLC20261—
+4K254176SinefixBAAT Medical Products B.V.20260—
+4K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…Smith & Nephew, Inc.20250—
+4K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+4K242529Tigon Medical All-Suture Anchors (ASA)Tigon Medical20242—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K240407ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture…Stryker Endoscopy20240—
+4K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.20230—
+4K230094Responsive Arthroscopy Stealth and Mini Stealth All-Suture AnchorsResponsive Arthroscopy, LLC20231—
+4K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+4K231278Knotless Suture AnchorRiverpoint Medical, LLC202331
+4K230892Fixone Biocomposite AnchorAju Pharm Co., Ltd.202308
+4K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+4K221396Arthrex FiberTak Suture AnchorArthrex, Inc.20223—
+4K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+4K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited20220—
+4K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+4K191227Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20201—
+4K191972ARIX Wrist SystemJeil Medical Corporation20190—
+4K182736OIC Suture Anchor SystemThe Orthopaedic Implant Company20180—
+4K173074ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker20185—
+4K171465Stryker Self-Punching ICONIXStryker20171—
+4K170098ICONIX TT All Suture AnchorStryker20173—
+4K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+4K132502Variax 2 SystemStryker Trauma AG201321—
+4K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+4K110773Tornier Insite FT Suture AnchorTornier, Inc.20115—
+4K1107815.5 / 6.5MM Spartan Peek Surture Implant with #2 Magnumwire / with Needles, Extraction…Arthrocare Corp.20110—
+4K1101645.5MM Spartan Peek Suture Implant W/ #2 Magnum Wire, Punch Tap, Extraction ToolArthrocare Corp.20111—
+5K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC20260—
+5K262677Iconix Knotless TRiverpoint Medical20260—
+5K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+5K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260—
+5K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical20251—
+5K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+5K250596Arthrex FiberTak Suture AnchorArthrex, Inc.20250—
+5K243323Iconix Knotless AnchorRiverpoint Medical20240—
+5K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+5K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+5K240213Iconix Knotless AnchorRiverpoint Medical20240—
+5K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+5K231078All-Suture AnchorRiverpoint Medical, LLC20233—
+5K230433Arthrex Knotless FiberTak Suture AnchorArthrex, Inc.20230—