510(k) Report

Devices descending from K925573

39 later devices reach Acufex T-Bar through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012342Ams Soft-Tissue Approximation SystemAmerican Medical Systems, Inc.20010—
+1K002261MR-IIISmith & Nephew, Inc.200030—
+1K955768Biofix Biodegradable Meniscus Arrow SystemBioscience, Inc.19966—
+2K092508Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse Curved,Fast Fix 360 AB…Smith & Nephew, Inc.2010173
+2K072322Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair SystemsSmith & Nephew, Inc.200715—
+2K053492BioductBioduct, LLC20070—
+2K031714Inion Trinion Biodegradable Meniscus ScrewInion, Ltd.20040—
+2K020480RBMSmith & Nephew, Inc.2002161
+2K012334Contour Meniscus Arrow, Models 541110, 541113, and 541116Bionx Implants, Inc.20011—
+2K993453Meniscus Arrow, Models 531110, 531113, 531116Bionx Implants, Ltd.19992—
+2K974538Meniscal Repair DeviceLinvatec Corp.19980—
+3K180191SuperBall Meniscal Repair SystemArcuro Medical, Ltd.20182—
+3K153667TRUESPAN Meniscal Repair SystemMedos International SARL20161—
+3K133770A.I.M. Knotless Meniscal Repair DeviceAnchor Innovation Medical (A.I.M.)20140—
+3K132079TFCC Fast-Fix KitSmith & Nephew, Inc.201311
+3K121861Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB…Smith & Nephew, Inc.201212—
+3K102339Conmed Linvatec Sequent Meniscal Repair DeviceConmed Linvatec20101—
+3K082518Dual Needle Suture Passer SystemCayenne Medical, Inc.20090—
+3K082535Covidien Sports Surgery as Meniscal Repair DeviceSurgical Devices, A Global Business Unit Covidien20080—
+3K073149Meniscal CinchArthrex, Inc.20089—
+3K041128Suture ArrowLinvatec Corp.20040—
+4K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.20260—
+4K233601Fixone Meniscal RepairAju Pharm Co., Ltd.202408
+4K230891SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair ImplantHealthium Medtech Limited20230—
+4K223500SuperBall Meniscal Repair SystemArcuro Medical, Ltd.20231—
+4K223122Menix®; Menix® DuoS.B.M. Sas (Science & Bio Materials)20230—
+4K220186Zone Specific AIMConmed Corporation20220—
+4K203393Fast-Fix FlexSmith & Nephew, Inc.20211—
+4K190707Arthrex SoftStitchArthrex, Inc.20202—
+4K190125FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd.20192—
+4K153087IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus…Ivy Sports Medicine, LLC20160—
+4K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…Smith & Nephew, Inc.2015140
+4K132043Arthrex SpeedcinchArthrex, Inc.20136—
+5K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.20260—
+5K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+5K244015SuperBall-RC™Arcuro Medical, Ltd.20250—
+5K222078Arthrex SoftStitchArthrex, Inc.20220—
+5K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd.20221—
+5K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc.20170—