510(k) Report

Devices descending from K002639

145 later devices reach Bioknotless Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K151747Sterispine PSSafe Orthopaedics20153—
+5K150092STERISPINE PS Pedicle ScrewSafe Orthopaedics20154—
+5K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek…Depuy Mitek, A Johnson & Johnson Company20141—
+5K140802Sterispine PSSafe Orthopaedics20144—
+5K140604Multifix S Knotless Fixation SystemArthroCare Corporation20142—
+5K1337944.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix…Depuy Mitek, A Johnson & Johnson Company20148—
+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—
+5K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company20130—
+5K130632Sterispine PS Pedicle ScrewSafe Orthopaedics20135—
+5K121299Sterispineps Pedicle Screw, Sterispineps RodSafe Orthopaedics20126—
+5K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+5K111716Knotless Suture Fixation SystemCore Essence Orthopaedics20110—
+5K110773Tornier Insite FT Suture AnchorTornier, Inc.20115—
+5K1107815.5 / 6.5MM Spartan Peek Surture Implant with #2 Magnumwire / with Needles, Extraction…Arthrocare Corp.20110—
+5K1101645.5MM Spartan Peek Suture Implant W/ #2 Magnum Wire, Punch Tap, Extraction ToolArthrocare Corp.20111—
+6K262047Grappler Suture Anchor SystemParagon 28, Inc.20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+6K252314Arthrex SutureTak Suture AnchorArthrex, Inc.20250—
+6K251809Arthrex FiberTak Suture AnchorArthrex, Inc.20251—
+6K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+6K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+6K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+6K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+6K203523Fixone hybrid knotless anchorAju Pharm Co., Ltd.202118
+6K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+6K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+6K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL20180—
+6K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL20181—
+6K173859HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20184—
+6K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL20172—
+6K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc.20152—
+6K151660MultiFIX S Knotless Fixation SystemArthroCare Corporation20151—
+6K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc.20140—
+6K132632Tornier Insite FT Suture Anchor with NeedlesTornier, Inc.20130—
+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—
+7K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260—
+7K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek20240—
+7K230892Fixone Biocomposite AnchorAju Pharm Co., Ltd.202308
+7K200949HEALIX ADVANCE Anchor with DYNATAPE SutureMedos International SARL20201—
+7K183506HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20192—
+7K153669MultiFIX S Ultra Knotless Fixation SystemArthocare Corporation20160—
+8K203794HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMedos International SARL20210—