510(k) Report

Devices descending from K121861

12 later devices reach Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra… through their predicates, nearest generation first.

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