510(k) Report

Devices descending from K070216

16 later devices reach Vari-Lase Bright Tip Fiber through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091551Vari-Lase Platinum Bright Tip Laser FiberVascular Solutions, Inc.20091—
+1K072332Vari-Lase Wire FiberVascular Solutions, Inc.2008141
+2K121861Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB…Smith & Nephew, Inc.201212—
+2K113140Vari-Lase Wirefiber Laser FiberVascular Solutions, Inc.20110—
+3K233601Fixone Meniscal RepairAju Pharm Co., Ltd.202408
+3K230891SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair ImplantHealthium Medtech Limited20230—
+3K223122Menix®; Menix® DuoS.B.M. Sas (Science & Bio Materials)20230—
+3K203393Fast-Fix FlexSmith & Nephew, Inc.20211—
+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—
+3K153667TRUESPAN Meniscal Repair SystemMedos International SARL20161—
+3K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…Smith & Nephew, Inc.2015140
+4K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.20260—
+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—
+5K244015SuperBall-RC™Arcuro Medical, Ltd.20250—