510(k) Report

Devices descending from K941364

25 later devices reach Acufex T-Fix Rotator Cuff Guide Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020159Smith & Nephew Twinfix TI Quick TSmith & Nephew, Inc.200224—
+2K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company201115—
+2K023021Modification to Smith & Nephew Twinfix TI Quick TSmith & Nephew, Inc.20027—
+3K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+3K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+3K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.201562
+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—
+4K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…Smith & Nephew, Inc.20250—
+4K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd.20250—
+4K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd.20250—
+4K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+4K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.20230—
+4K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+4K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+4K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+4K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+4K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited20220—
+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—