510(k) Report

Devices descending from K003227

526 later devices reach Bio-Absorbable Corkscrew Model AR-1920B through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+4K171141Arthrex SwiveLock AnchorsArthrex, Inc.201729—
+4K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20172—
+4K163258CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation20179—
+4K162198GFS UltimateParcus Medical, LLC20168—
+4K162386KATOR Suture AnchorKator, LLC20163—
+4K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC20164—
+4K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.201562
+4K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+4K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc.20152—
+4K151201Stryker ICONIX with NeedlesStryker201510—
+4K150359Tensyn PlugDallen Medical, Inc.20150—
+4K142643Stabilynx PEEK Suture AnchorD3 Dc, LLC /Stabilynx, Inc.20140—
+4K1425744.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti…Depuy Mitek, A Johnson & Johnson Company20140—
+4K142653G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporation, Ltd.20140—
+4K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+4K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+4K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+4K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek…Depuy Mitek, A Johnson & Johnson Company20141—
+4K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc.20140—
+4K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+4K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC201431—
+4K133036Apollo Suture Anchor System and Titan ScrewsAmendia, Inc.201471
+4K133671Iconix All Suture AnchorsStryker Corp.201425—
+4K133757GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC201416—
+4K1337944.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix…Depuy Mitek, A Johnson & Johnson Company20148—
+4K133275Mini TightropeArthrex, Inc.201411—
+4K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137—
+4K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…Depuy Mitek, A Johnson & Johnson Company20131—
+4K132502Variax 2 SystemStryker Trauma AG201321—
+4K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+4K131974Healix Advance Knotless BR Anchor (6.5MM)Depuy Mitek, A Johnson & Johnson Company20133—
+4K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec201317—
+4K131683Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company20133—
+4K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company20130—
+4K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+4K123579Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SLSmith & Nephew, Inc.20134—
+4K120356NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl20121—
+4K121890Genesys Pressft Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec20120—
+4K112965Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec201196
+4K111032CMC Cable FixInstratek, Inc.20112—
+4K111590Rog Suture Anchor, Rog Knotless Suture AnchorRog Sports Medicine, Inc.20115—
+4K111631Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture Anchor, Rotator Cuff…Depuy Mitek, A Johnson & Johnson Company20111—
+4K111397Titan TI Suture Anchor SystemArthrocare Corp.20110—
+4K102262Arthocare Spartan Peek Suture Implant System; Punch Tap ; Extraction ToolArthrocare Corp.20102—
+4K101184Titan TI Suture Anchor System, Models 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022…Arthrocare Corp.20104—
+4K091870Tornier, Piton Fixation Implant SystemTornier20096—
+4K090075Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC200913—
+4K080447Surgicraft Screw Fixation SystemSurgicraft, Ltd.20080—
+5K262047Grappler Suture Anchor SystemParagon 28, Inc.20260—
+5K261511Xpert AnkleNewclip Technics20260—
+5K260018Arthrex FiberButtonArthrex, Inc.20260—
+5K252635ArthroTAK Tendon Anchor KitArthroTAK, LLC20261—
+5K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+5K254176SinefixBAAT Medical Products B.V.20260—
+5K253538TeKBrace Knotless AnchorTheramicro20260—
+5K254182AsterOsteonic Co., Ltd.20260—
+5K251680Biosteon® ScrewBiocomposites, Ltd.20260—
+5K253763Y-Knotless™ Flex AnchorsConmed Corporation20261—
+5K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+5K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+5K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…Smith & Nephew, Inc.20250—
+5K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+5K243469SignexOsteonic Co., Ltd.20250—
+5K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+5K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+5K242529Tigon Medical All-Suture Anchors (ASA)Tigon Medical20242—
+5K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+5K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek20240—
+5K241539Activmotion SNewclip Technics20240—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+5K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+5K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+5K240407ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture…Stryker Endoscopy20240—
+5K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+5K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+5K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.20230—
+5K230517Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends…Jarmon Medical, LLC (Dba Legends Orthopedics)20230—
+5K230094Responsive Arthroscopy Stealth and Mini Stealth All-Suture AnchorsResponsive Arthroscopy, LLC20231—
+5K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+5K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+5K231857Arthrex TightRope IIArthrex, Inc.20234—
+5K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+5K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S…Healthium Medtech Limited20230—
+5K231278Knotless Suture AnchorRiverpoint Medical, LLC202331
+5K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+5K230892Fixone Biocomposite AnchorAju Pharm Co., Ltd.202308
+5K230123Apollo Knotless Suture AnchorMaruho Medical20230—
+5K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+5K223284SutureLoc™ ImplantArthrex, Inc.20230—
+5K223795FairFix QT Adjustable ButtonMedacta International S.A.20230—
+5K221396Arthrex FiberTak Suture AnchorArthrex, Inc.20223—
+5K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+5K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+5K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+5K222169FairFix Adjustable Button SystemMedacta International S.A.20220—
+5K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited20220—
+5K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A.20220—
+5K220757Argo Knotless SP AnchorConmed Corporation20226—