510(k) Report

Devices descending from K092508

17 later devices reach Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse Curved,Fast Fix… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180191SuperBall Meniscal Repair SystemArcuro Medical, Ltd.20182—
+1K153667TRUESPAN Meniscal Repair SystemMedos International SARL20161—
+1K132079TFCC Fast-Fix KitSmith & Nephew, Inc.201311
+1K121861Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB…Smith & Nephew, Inc.201212—
+2K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.20260—
+2K233601Fixone Meniscal RepairAju Pharm Co., Ltd.202408
+2K230891SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair ImplantHealthium Medtech Limited20230—
+2K223500SuperBall Meniscal Repair SystemArcuro Medical, Ltd.20231—
+2K223122Menix®; Menix® DuoS.B.M. Sas (Science & Bio Materials)20230—
+2K203393Fast-Fix FlexSmith & Nephew, Inc.20211—
+2K190125FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd.20192—
+2K153087IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus…Ivy Sports Medicine, LLC20160—
+2K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…Smith & Nephew, Inc.2015140
+3K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.20260—
+3K244015SuperBall-RC™Arcuro Medical, Ltd.20250—
+3K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd.20221—
+3K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc.20170—