510(k) Report

Devices descending from K000506

186 later devices reach Bio-Fastak Suture Anchor, Model AR-1324B through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070882Stryker Peek Twinloop TacStryker Endoscopy200735—
+1K051983Model 3000 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc.20051121
+1K051219PushlockArthrex, Inc.2005151—
+2K203334The Citrefix Knotless Suture AnchorAcuitive Technologies, Inc.20212—
+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—
+2K093897Smith & Nephew Footprint Ultra PK Suture AnchorSmith & Nephew Inc., Endoscopy Div.2010292
+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—
+2K083268Tornier, Inc., Insite Suture AnchorsTornier, Inc.20097—
+2K073509Twinfix PK FP Suture AnchorSmith & Nephew, Inc.200864—
+2K061349Opus Labralock P Knotless Fixation DeviceArthrocare Corp.200650—
+2K060970Axyaloop Nonabsorbable Bone AnchorAxya Medical, Inc.20061021
+2K060914Trident AnchorJohnson & Johnson Company200633—
+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—
+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—
+3K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+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—
+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—
+3K133671Iconix All Suture AnchorsStryker Corp.201425—
+3K130467Porous Morphix Suture Anchor with Force Fiber SutureMedShape, Inc.20130—
+3K132632Tornier Insite FT Suture Anchor with NeedlesTornier, Inc.20130—
+3K122635Tornier Insite FT Biocomposite Suture AnchorTornier, 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—
+3K110773Tornier Insite FT Suture AnchorTornier, Inc.20115—
+3K103262Quickdraw Convertible Fixation Implant SystemTornier, Inc.20110—
+3K102143Suspension Acromioclavicular (AC) Repair SystemSuspension Orthopaedic Solutions, LLC20100—
+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—
+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—
+4K254176SinefixBAAT Medical Products B.V.20260—
+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—
+4K200503ATL AnchorsInternational Life Sciences202022
+4K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+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—
+4K170098ICONIX TT All Suture AnchorStryker20173—
+4K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.201562
+4K151897MultiFIX® P Knotless Fixation DeviceArthroCare Corporation20150—
+4K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc.20152—
+4K151201Stryker ICONIX with NeedlesStryker201510—
+4K143660Milagro / Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company20154—
+4K150166Extremity Medical Suture AnchorExtremity Medical, LLC20150—
+4K143392Quattro Bolt Tenodesis ScrewCayenne Medical, Inc.20150—
+4K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc.20140—
+4K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…Depuy Mitek, A Johnson & Johnson Company20131—
+4K131182Multifix S Knotless Fixation DeviceArthocare Corporation20139—
+4K123651Cinchlock Knotless Suture AnchorPivot Medical20130—
+4K120943Speedlock Hip Knotless Fixation Implant Speedlock Hip Drill Speedlock Hip Guide Crown…ArthroCare Corporation20121—
+4K121018Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture anSmith & Nephew, Inc.201229—
+4K111044Speedlock Knotless Fixation Device; 3.0MM Drill; Sharp Tipped Obturator; Low Profile…ArthroCare Corporation20114—
+4K102757Lifenet SystemPhysio-Control, Inc.20107—
+4K101437Speedfix Suture SystemArthrocare Corp.201012—
+4K091503Magnum MP Fixation DeviceArthrocare Corp.20090—
+4K090530Spin-Loc Suture Anchor System FG-0302-01,FG-0305-01Ross Creek Medical, Inc.20092—
+4K083240Opus MAGNUM2 and Opus Magnum X Knotless Fixation DevicesArthrocare Corp.200903
+4K081893Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500Arthrocare Corp.200816—
+4K080335Tornier Cinch Knotless Fixation Implant SystemTornier, Inc.20087—