510(k) Report

Devices descending from K041069

100 later devices reach Spiralok Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071481Healix AnchorDepuy Mitek, A Johnson & Johnson Company200799—
+2K120449Healix Advance Peek AnchorDepuy Mitek201250—
+2K110229Rog Suture Anchor 5.5MM, 2.9MMRog Sports Medicine, Inc.20116—
+2K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company20116—
+2K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company201115—
+2K082282Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co.200821—
+2K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company2008441
+3K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+3K213110AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In AnchorAuxein Medical Private Limited20220—
+3K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+3K192949Flower Suture Anchor SetFlower Orthopedics Corporation20200—
+3K183501Parcus Twist AP Suture AnchorsParcus Medical, LLC20192—
+3K183279HEALIX Ti ANCHOR with DYNACORDMedos International SARL20191—
+3K171299Fixone Biocomposite AnchorAju Pharm Co., Ltd.20174—
+3K170639HEALIX ADVANCE Anchor with PERMATAPE SutureMedos International SARL20171—
+3K1425744.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti…Depuy Mitek, A Johnson & Johnson Company20140—
+3K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+3K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek…Depuy Mitek, A Johnson & Johnson Company20141—
+3K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC201431—
+3K133036Apollo Suture Anchor System and Titan ScrewsAmendia, Inc.201471
+3K1337944.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix…Depuy Mitek, A Johnson & Johnson Company20148—
+3K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…Depuy Mitek, A Johnson & Johnson Company20131—
+3K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company20130—
+3K120078Healix Advance BR AnchorDepuy Mitek Inc., Johnson and Johnson Company20129—
+3K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+3K112249Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company201113—
+3K111590Rog Suture Anchor, Rog Knotless Suture AnchorRog Sports Medicine, Inc.20115—
+3K111631Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture Anchor, Rotator Cuff…Depuy Mitek, A Johnson & Johnson Company20111—
+3K100012Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS…Depuy Mitek, A Johnson & Johnson Company201024—
+3K090124Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814Depuy Mitek, A Johnson & Johnson Company2009252
+4K262047Grappler Suture Anchor SystemParagon 28, Inc.20260—
+4K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+4K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+4K232513X-Twist Biocomposite Suture AnchorParcus Medical20230—
+4K230517Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends…Jarmon Medical, LLC (Dba Legends Orthopedics)20230—
+4K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+4K230123Apollo Knotless Suture AnchorMaruho Medical20230—
+4K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+4K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+4K203794HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMedos International SARL20210—
+4K202777VeriFixx™ Small Bone ImplantArmis Biopharma, Inc.20200—
+4K201850Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20203—
+4K192484Fixone Biocomposite AnchorAju Pharm Co., Ltd.20203—
+4K192824Parcus Knotless AP Suture AnchorsParcus Medical, LLC20190—
+4K191424Interphalangeal Joint Fusion Device RangeNeosteo20190—
+4K191483HEALIX ADVANCE Anchor with DYNA+TAPE SuturesMedos International SARL20190—
+4K183055Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC20194—
+4K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL20180—
+4K173859HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20184—
+4K161449HammerTech Fixation SystemFusion Orthopedics, LLC20165—
+4K152710HammerFiX DeviceExtremity Medical, LLC20151—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+4K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201516—
+4K142230Apollo Suture Anchor System and Titan ScrewsValeris Medical201451
+4K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.20140—
+4K130917Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company201392
+4K130539Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company20134—
+4K112417VariousDepuy Mitek, A Johnson & Johnson Company20120—
+4K113299Rog Suture AnchorRog Sports Medicine, Inc.20112—
+4K112991Modified Rog Suture AnchorRog Sports Medicine, Inc.20111—
+5K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+5K230655PEEK RCI Screw; Bio-Composite Screw; SignaLoc ScrewSignature Orthopaedics Pty, Ltd.20230—
+5K203523Fixone hybrid knotless anchorAju Pharm Co., Ltd.202118
+5K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+5K213421Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20212—
+5K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+5K200949HEALIX ADVANCE Anchor with DYNATAPE SutureMedos International SARL20201—
+5K192810Apollo Suture Anchor SystemValeris Medical20201—
+5K183506HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20192—
+5K182736OIC Suture Anchor SystemThe Orthopaedic Implant Company20180—
+5K182684HammerTechTM Fixation SystemFusion Orthopedics, LLC20180—
+5K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL20181—
+5K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL20172—
+5K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+5K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+5K152255BoneCam Suture AnchorsValeris Medical20151—
+5K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC201515—
+5K131974Healix Advance Knotless BR Anchor (6.5MM)Depuy Mitek, A Johnson & Johnson Company20133—
+5K131683Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company20133—
+6K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek20240—
+6K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+6K230892Fixone Biocomposite AnchorAju Pharm Co., Ltd.202308
+6K193108Bonecam Suture AnchorValeris Medical, Inc.20200—
+6K181872MIS Bunion SystemCrossroads Extremity Systems, LLC201914—
+7K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+7K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+7K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+7K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+7K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+7K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+7K190658MIS Bunion Plating SystemCrossroads Extremity Systems, LLC20192—
+8K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+8K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+8K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+8K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+9K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+9K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+9K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+9K243658TMC Compression Implant SystemTreace Medical Concepts20242—