510(k) Report

Devices descending from K061665

114 later devices reach Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd.20250—
+1K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+1K181680ICONN Answer II Suture AnchorIconn Orthopedics, LLC20180—
+1K180464AEVUMED PHANTOM Suture AnchorsAevumed, Inc.20184—
+1K173788Arthrex Corkscrew FTArthrex, Inc.20185—
+1K152236KATOR Suture AnchorKator, LLC20154—
+1K113274Footprint Ultra PK Suture AnchorSmith & Nephew, Inc.201216—
+1K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc.201213—
+1K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC201149—
+1K110538Pro Fixation SystemSynovis Orthopedic & Woundcare20110—
+1K092133Arthrocare Titanium Suture Anchor, Model 22-9055,22-9055N, 22-9065, 22-9065NArthrocare Corp.20095—
+1K080335Tornier Cinch Knotless Fixation Implant SystemTornier, Inc.20087—
+1K071157Stryker Peek and Titanium Soft Eyelet AnchorsStryker Endoscopy2007125
+1K070758Stryker Peek Zip Suture AnchorStryker Endoscopy20072—
+2K254306Aevumed FENIX Suture AnchorAevumed, Inc.20260—
+2K260004Aevumed PROTEKT Suture AnchorAevumed, Inc.20262—
+2K250526Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture AnchorArthrex, Inc.20250—
+2K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+2K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+2K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+2K193245Dunamis PunchTac Suture AnchorsDunamis, LLC20200—
+2K192984APTUS Clavicle SystemMedartis AG20206—
+2K193157Arthrex 3.9mm Corkscrew Suture AnchorArthrex, Inc.20191—
+2K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+2K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+2K180759SECULOK™ Suture AnchorU&I Corporation20180—
+2K173269KATOR Suture AnchorKator, LLC20182—
+2K171964LigaMetrics Suture AnchorsMortise Medical, LLC20170—
+2K162386KATOR Suture AnchorKator, LLC20163—
+2K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.201562
+2K151201Stryker ICONIX with NeedlesStryker201510—
+2K142643Stabilynx PEEK Suture AnchorD3 Dc, LLC /Stabilynx, Inc.20140—
+2K123579Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SLSmith & Nephew, Inc.20134—
+2K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+2K111397Titan TI Suture Anchor SystemArthrocare Corp.20110—
+2K102262Arthocare Spartan Peek Suture Implant System; Punch Tap ; Extraction ToolArthrocare Corp.20102—
+2K101184Titan TI Suture Anchor System, Models 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022…Arthrocare Corp.20104—
+2K091870Tornier, Piton Fixation Implant SystemTornier20096—
+2K080447Surgicraft Screw Fixation SystemSurgicraft, Ltd.20080—
+3K260018Arthrex FiberButtonArthrex, Inc.20260—
+3K260761APTUS Clavicle System 2.8Medartis AG20260—
+3K252635ArthroTAK Tendon Anchor KitArthroTAK, LLC20261—
+3K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…Smith & Nephew, Inc.20250—
+3K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd.20250—
+3K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+3K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+3K240407ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture…Stryker Endoscopy20240—
+3K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.20230—
+3K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+3K231278Knotless Suture AnchorRiverpoint Medical, LLC202331
+3K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+3K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+3K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited20220—
+3K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+3K191972ARIX Wrist SystemJeil Medical Corporation20190—
+3K182736OIC Suture Anchor SystemThe Orthopaedic Implant Company20180—
+3K173074ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker20185—
+3K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+3K132502Variax 2 SystemStryker Trauma AG201321—
+3K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+3K110773Tornier Insite FT Suture AnchorTornier, Inc.20115—
+3K1107815.5 / 6.5MM Spartan Peek Surture Implant with #2 Magnumwire / with Needles, Extraction…Arthrocare Corp.20110—
+3K1101645.5MM Spartan Peek Suture Implant W/ #2 Magnum Wire, Punch Tap, Extraction ToolArthrocare Corp.20111—
+4K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC20260—
+4K262677Iconix Knotless TRiverpoint Medical20260—
+4K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+4K243323Iconix Knotless AnchorRiverpoint Medical20240—
+4K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+4K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+4K240213Iconix Knotless AnchorRiverpoint Medical20240—
+4K231078All-Suture AnchorRiverpoint Medical, LLC20233—
+4K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+4K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+4K173556Injection ScrewBiedermann Medtech, Inc.20180—
+4K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+4K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc.20152—
+4K140769Variax 2 SystemStryker Trauma AG201419—
+4K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc.20140—
+4K132632Tornier Insite FT Suture Anchor with NeedlesTornier, Inc.20130—
+5K253538TeKBrace Knotless AnchorTheramicro20260—
+5K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+5K241577Iconix® AnchorRiverpoint Medical20240—
+5K233468Iconix AnchorRiverpoint Medical20231—
+5K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K173135VariAx 2 SystemStryker GmbH201713—
+5K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+6K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+6K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+6K252144Iconix Speed Anchor; Iconix Speed HA+ AnchorRiverpoint Medical20250—
+6K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+6K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+6K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+6K180500VariAx 2 SystemStryker GmbH201812—
+7K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+7K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+7K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+7K232652Anatomical Plating System (various)Tyber Medical, LLC2023320