510(k) Report

Devices descending from K040004

43 later devices reach Orthocord Suture through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162247PermatapeMedos International SARL20161—
+1K161638SPEEDTRAP Graft Preparation SystemMedos International SARL20160—
+1K130814Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company20133—
+1K123668OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company20130—
+1K094028CP-Fiber (Orthofiber)Cp Medical20100—
+1K082282Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co.200821—
+1K080918Double Armed Meniscal Needles with Size #2-0 Orthocord, Meniscal Needle with Wire Eyelet…Depuy Mitek20080—
+1K043298Blue Orthocord SutureDepuy Mitek2004336
+1K042233Passing Needle with Ethibond, Panacryl or Orthocord SutureDepuy Mitek, A Johnson & Johnson Company20040—
+1K041806Passing Needle with Ethibond, Panacryl or Orthocord Suture; and Passing Needle with…Depuy Mitek, A Johnson & Johnson Company20041—
+2K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+2K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+2K220219PERMALOOP Suture, PERMATAPE SutureMedos International SARL20220—
+2K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—
+2K183279HEALIX Ti ANCHOR with DYNACORDMedos International SARL20191—
+2K1425744.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti…Depuy Mitek, A Johnson & Johnson Company20140—
+2K111631Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture Anchor, Rotator Cuff…Depuy Mitek, A Johnson & Johnson Company20111—
+2K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company201115—
+2K071257Mini Quickanchor and Quickanchor Plus with OrthocordDepuy Mitek, A Johnson & Johnson Company20078—
+3K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+3K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+3K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+3K203794HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMedos International SARL20210—
+3K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+3K143473Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles…Cayenne Medical, Inc.20150—
+3K121356Micro/Mini N-PK (H) Bone AnchorAnulex Technologies, Inc.20120—
+3K121354Micro/Mini N-PK (F) Bone AnchorAnulex Technologies, Inc.20120—
+3K112417VariousDepuy Mitek, A Johnson & Johnson Company20120—
+3K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company20116—
+4K262047Grappler Suture Anchor SystemParagon 28, Inc.20260—
+4K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+4K253538TeKBrace Knotless AnchorTheramicro20260—
+4K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+4K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+4K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+4K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+4K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+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—
+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—
+4K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+5K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL20180—