510(k) Report

Devices descending from K002261

30 later devices reach MR-III through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092508Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse Curved,Fast Fix 360 AB…Smith & Nephew, Inc.2010173
+1K072322Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair SystemsSmith & Nephew, Inc.200715—
+1K020480RBMSmith & Nephew, Inc.2002161
+2K180191SuperBall Meniscal Repair SystemArcuro Medical, Ltd.20182—
+2K153667TRUESPAN Meniscal Repair SystemMedos International SARL20161—
+2K133770A.I.M. Knotless Meniscal Repair DeviceAnchor Innovation Medical (A.I.M.)20140—
+2K132079TFCC Fast-Fix KitSmith & Nephew, Inc.201311
+2K121861Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB…Smith & Nephew, Inc.201212—
+2K102339Conmed Linvatec Sequent Meniscal Repair DeviceConmed Linvatec20101—
+2K082518Dual Needle Suture Passer SystemCayenne Medical, Inc.20090—
+2K082535Covidien Sports Surgery as Meniscal Repair DeviceSurgical Devices, A Global Business Unit Covidien20080—
+2K073149Meniscal CinchArthrex, Inc.20089—
+3K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.20260—
+3K233601Fixone Meniscal RepairAju Pharm Co., Ltd.202408
+3K230891SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair ImplantHealthium Medtech Limited20230—
+3K223500SuperBall Meniscal Repair SystemArcuro Medical, Ltd.20231—
+3K223122Menix®; Menix® DuoS.B.M. Sas (Science & Bio Materials)20230—
+3K220186Zone Specific AIMConmed Corporation20220—
+3K203393Fast-Fix FlexSmith & Nephew, Inc.20211—
+3K190707Arthrex SoftStitchArthrex, Inc.20202—
+3K190125FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd.20192—
+3K153087IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus…Ivy Sports Medicine, LLC20160—
+3K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…Smith & Nephew, Inc.2015140
+3K132043Arthrex SpeedcinchArthrex, Inc.20136—
+4K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.20260—
+4K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+4K244015SuperBall-RC™Arcuro Medical, Ltd.20250—
+4K222078Arthrex SoftStitchArthrex, Inc.20220—
+4K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd.20221—
+4K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc.20170—