510(k) Report

Devices descending from K971723

274 later devices reach Fastak Suture Anchor (11.7MM)/(7.5MM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082729Rimclose Bone AnchorAnulex Technologies, Inc.20080—
+1K072063KFX Tissue Fixation System and AccessoriesKfx Medical200718—
+1K071520Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC20077—
+1K070882Stryker Peek Twinloop TacStryker Endoscopy200735—
+1K051219PushlockArthrex, Inc.2005151—
+1K050358Artherx Corkscrew FT II Suture AnchorArthrex, Inc.200540—
+1K990361Headed Bio-Absorbable Corkscrew Model #AR-1921BUArthrex, Inc.199979—
+2K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+2K203334The Citrefix Knotless Suture AnchorAcuitive Technologies, Inc.20212—
+2K193377TopLock Anchor SystemFusion Orthopedics, LLC20200—
+2K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+2K191242HEALIX ADVANCE SP BIOCOMPOSITE AnchorMedos International SARL20192—
+2K182941HEALIX ADVANCE SP PEEK AnchorMedos International SARL20192—
+2K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL20181—
+2K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL20172—
+2K133235Threaded Peek K-WireMtp Solutions, LLC20142—
+2K120509Stryker All Suture AnchorsStryker201227—
+2K1208243.9MM Reelx STT Suture Anchor SystemStryker Corp.20121—
+2K113297Knotilus Anchor SystemT.A.G. Medical Products Corporation, Ltd.20123—
+2K110538Pro Fixation SystemSynovis Orthopedic & Woundcare20110—
+2K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc.20103—
+2K093897Smith & Nephew Footprint Ultra PK Suture AnchorSmith & Nephew Inc., Endoscopy Div.2010292
+2K092133Arthrocare Titanium Suture Anchor, Model 22-9055,22-9055N, 22-9065, 22-9065NArthrocare Corp.20095—
+2K091202Wedgeloc 180X Standard Suture Anchor with Opti Fiber Sutures,Model 1000-01 Tab Varying…Medshape Solutions20093—
+2K083792Wedgeloc Suture Anchor with Opti-Fiber Sutures, Model 1000-01-055Medshape Solutions20094—
+2K090128Tac-Tite (TM)Core Essence Orthopaedics, Inc.20091—
+2K090075Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC200913—
+2K081598Suture Lock Nail Bone Anchor with White (KFX-W-200) & Blue (KFX-B-200) Fiberforce SutureKfx Medical200816—
+2K073509Twinfix PK FP Suture AnchorSmith & Nephew, Inc.200864—
+2K0802295.5 MM Suture Lock Bone Screw AnchorKfx Medical20080—
+2K061349Opus Labralock P Knotless Fixation DeviceArthrocare Corp.200650—
+2K060914Trident AnchorJohnson & Johnson Company200633—
+2K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd.200377—
+2K020056Duet Suture AnchorBionx Implants, Ltd.200278—
+3K250095All-Suture Dual Anchor SystemSuturetech, Inc.20250—
+3K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd.20250—
+3K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek20240—
+3K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+3K232592Citrelock® DuoAcuitive Technologies, Inc.20230—
+3K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+3K220966SinefixBAAT Medical Products B.V.20231—
+3K220833Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock…Acuitive Technologies, Inc.20221—
+3K210498Betta Link Knotless Implant SystemT.A.G. Medical Products Corporation, Ltd.202101
+3K202178VersaLoop Anchor SystemT.A.G. Medical Products Corporation, Ltd.20200—
+3K2018836.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite AnchorMedos International SARL20201—
+3K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC20203—
+3K193558HEALICOIL Knotless Suture AnchorsSmith & Nephew, Inc.20200—
+3K182264ICONN Revolution Knotless Suture AnchorIconn Orthopedics, LLC20180—
+3K180759SECULOK™ Suture AnchorU&I Corporation20180—
+3K173269KATOR Suture AnchorKator, LLC20182—
+3K180274Ventix Link Knotless Anchor with InserterCayenne Medical, Inc.20180—
+3K171964LigaMetrics Suture AnchorsMortise Medical, LLC20170—
+3K160118STROPP (Single Tunnel Repair of Plantar Plate)Crossroads Extremity Systems, LLC20160—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K141290Helical Ridge Peek Interference ScrewMedShape, Inc.20140—
+3K141711Pontis 3MM Suture Anchors with Ultra-High Molecular Weight Polyethylene Suture, Pontis…Pontis Orthopaeeics, LLC20140—
+3K140127Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC20141—
+3K133671Iconix All Suture AnchorsStryker Corp.201425—
+3K130467Porous Morphix Suture Anchor with Force Fiber SutureMedShape, Inc.20130—
+3K123579Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SLSmith & Nephew, Inc.20134—
+3K122314Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek OnlyCayenne Medical, Inc.20126—
+3K120096Multifix P Knotless Fixation DeviceArthroCare Corporation201211—
+3K113274Footprint Ultra PK Suture AnchorSmith & Nephew, Inc.201216—
+3K112876Cufflink (TM) Knotless Anchor with Inserter, 4.5MM/5.5MM - Peek Only, Cufflink SP (TM)…Cayenne Medical, Inc.20117—
+3K111716Knotless Suture Fixation SystemCore Essence Orthopaedics20110—
+3K111000Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC20114—
+3K111397Titan TI Suture Anchor SystemArthrocare Corp.20110—
+3K103262Quickdraw Convertible Fixation Implant SystemTornier, Inc.20110—
+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—
+3K100532Versalok Peek Anchor with Orthocord Suture, Models 210818, 210819Depuy Mitek, A Johnson & Johnson Company20100—
+3K093925Lifenet SystemPhysio-Control, Inc.20108—
+3K093428Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc.200941—
+3K092914Wedgeloc 180X (Standard) and (Cortical) Suture Anchor with Opti-Fiber SuturesMedshape Solutions20090—
+3K091094Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC20097—
+3K090615Opus Speedlock Knotless Fixation DeviceArthrocare Corp.2009181
+3K083151Extremity Medical Suture AnchorExtremity Medical, LLC20091—
+3K070227Opus Magnum PI Knotless Fixation DeviceArthrocare Corp.200727—
+3K063478Versalok Anchor with Free Strands of Orthocord Suture (210808), Ethibond Suture…Depuy Mitek, A Johnson & Johnson Company200632—
+3K053561Bio-Mini Revo Suture AnchorConmed Linvatec200675—
+3K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…Linvatec Biomaterials, Ltd.200476—
+4K254176SinefixBAAT Medical Products B.V.20260—
+4K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+4K242529Tigon Medical All-Suture Anchors (ASA)Tigon Medical20242—
+4K240407ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture…Stryker Endoscopy20240—
+4K233730Footprint Mini PK, 3.5mm Suture AnchorSmith & Nephew20240—
+4K230094Responsive Arthroscopy Stealth and Mini Stealth All-Suture AnchorsResponsive Arthroscopy, LLC20231—
+4K221396Arthrex FiberTak Suture AnchorArthrex, Inc.20223—
+4K212739ActiFlipParcus Medical, LLC20210—
+4K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+4K200503ATL AnchorsInternational Life Sciences202022
+4K191227Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20201—
+4K190915OsteoFab Suture AnchorsOxford Performance Materials, Inc.20190—
+4K182507Tigon Medical Tissue AnchorsTigon Medical20192—
+4K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+4K182736OIC Suture Anchor SystemThe Orthopaedic Implant Company20180—
+4K180594Knotless SutureTak AnchorsArthrex, Inc.20181—
+4K171465Stryker Self-Punching ICONIXStryker20171—
+4K171020Arthrex Knotless SutureTak AnchorArthrex, Inc.201727—