510(k) Report

Devices descending from K021883

116 later devices reach Biofastin RC Threaded Suture Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051250Axya, Model 6500 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc.200511—
+1K041069Spiralok AnchorDepuy Mitek, A Johnson & Johnson Company200410016
+1K041698Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc.200414—
+2K083268Tornier, Inc., Insite Suture AnchorsTornier, Inc.20097—
+2K071481Healix AnchorDepuy Mitek, A Johnson & Johnson Company200799—
+2K061949Doubleplay Suture AnchorBiocomposites, Ltd.20060—
+2K060970Axyaloop Nonabsorbable Bone AnchorAxya Medical, Inc.20061021
+2K051983Model 3000 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc.20051121
+3K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+3K132632Tornier Insite FT Suture Anchor with NeedlesTornier, Inc.20130—
+3K122635Tornier Insite FT Biocomposite Suture AnchorTornier, Inc.20130—
+3K120449Healix Advance Peek AnchorDepuy Mitek201250—
+3K110773Tornier Insite FT Suture AnchorTornier, Inc.20115—
+3K110229Rog Suture Anchor 5.5MM, 2.9MMRog Sports Medicine, Inc.20116—
+3K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company20116—
+3K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company201115—
+3K102143Suspension Acromioclavicular (AC) Repair SystemSuspension Orthopaedic Solutions, LLC20100—
+3K082282Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co.200821—
+3K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company2008441
+4K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+4K213110AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In AnchorAuxein Medical Private Limited20220—
+4K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+4K192949Flower Suture Anchor SetFlower Orthopedics Corporation20200—
+4K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+4K183501Parcus Twist AP Suture AnchorsParcus Medical, LLC20192—
+4K183279HEALIX Ti ANCHOR with DYNACORDMedos International SARL20191—
+4K171299Fixone Biocomposite AnchorAju Pharm Co., Ltd.20174—
+4K170639HEALIX ADVANCE Anchor with PERMATAPE SutureMedos International SARL20171—
+4K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc.20152—
+4K1425744.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti…Depuy Mitek, A Johnson & Johnson Company20140—
+4K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+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—
+4K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC201431—
+4K133036Apollo Suture Anchor System and Titan ScrewsAmendia, Inc.201471
+4K1337944.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix…Depuy Mitek, A Johnson & Johnson Company20148—
+4K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…Depuy Mitek, A Johnson & Johnson Company20131—
+4K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company20130—
+4K120078Healix Advance BR AnchorDepuy Mitek Inc., Johnson and Johnson Company20129—
+4K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+4K112249Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company201113—
+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—
+4K100012Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS…Depuy Mitek, A Johnson & Johnson Company201024—
+4K090124Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814Depuy Mitek, A Johnson & Johnson Company2009252
+5K262047Grappler Suture Anchor SystemParagon 28, Inc.20260—
+5K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+5K253538TeKBrace Knotless AnchorTheramicro20260—
+5K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+5K232513X-Twist Biocomposite Suture AnchorParcus Medical20230—
+5K230517Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends…Jarmon Medical, LLC (Dba Legends Orthopedics)20230—
+5K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+5K230123Apollo Knotless Suture AnchorMaruho Medical20230—
+5K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+5K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+5K203794HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMedos International SARL20210—
+5K202777VeriFixx™ Small Bone ImplantArmis Biopharma, Inc.20200—
+5K201850Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20203—
+5K192484Fixone Biocomposite AnchorAju Pharm Co., Ltd.20203—
+5K192824Parcus Knotless AP Suture AnchorsParcus Medical, LLC20190—
+5K191424Interphalangeal Joint Fusion Device RangeNeosteo20190—
+5K191483HEALIX ADVANCE Anchor with DYNA+TAPE SuturesMedos International SARL20190—
+5K183055Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC20194—
+5K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL20180—
+5K173859HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20184—
+5K161449HammerTech Fixation SystemFusion Orthopedics, LLC20165—
+5K152710HammerFiX DeviceExtremity Medical, LLC20151—
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+5K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201516—
+5K142230Apollo Suture Anchor System and Titan ScrewsValeris Medical201451
+5K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.20140—
+5K130917Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company201392
+5K130539Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company20134—
+5K112417VariousDepuy Mitek, A Johnson & Johnson Company20120—
+5K113299Rog Suture AnchorRog Sports Medicine, Inc.20112—
+5K112991Modified Rog Suture AnchorRog Sports Medicine, Inc.20111—
+6K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+6K230655PEEK RCI Screw; Bio-Composite Screw; SignaLoc ScrewSignature Orthopaedics Pty, Ltd.20230—
+6K203523Fixone hybrid knotless anchorAju Pharm Co., Ltd.202118
+6K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+6K213421Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20212—
+6K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+6K200949HEALIX ADVANCE Anchor with DYNATAPE SutureMedos International SARL20201—
+6K192810Apollo Suture Anchor SystemValeris Medical20201—
+6K183506HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20192—
+6K182736OIC Suture Anchor SystemThe Orthopaedic Implant Company20180—
+6K182684HammerTechTM Fixation SystemFusion Orthopedics, LLC20180—
+6K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL20181—
+6K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL20172—
+6K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+6K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+6K152255BoneCam Suture AnchorsValeris Medical20151—
+6K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC201515—
+6K131974Healix Advance Knotless BR Anchor (6.5MM)Depuy Mitek, A Johnson & Johnson Company20133—
+6K131683Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company20133—
+7K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek20240—
+7K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+7K230892Fixone Biocomposite AnchorAju Pharm Co., Ltd.202308
+7K193108Bonecam Suture AnchorValeris Medical, Inc.20200—