510(k) Report

Devices descending from K000541

40 later devices reach Silk Nonabsorbable Surgical Sutures, Usp through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012124Mersilk Black Silk Braided Non-Absorbable Suture, UspJohnson & Johnson Medical (China), Ltd.200139—
+2K041589Arthrex Fiberwire with SilkArthrex, Inc.20044—
+2K032245Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape (TM), 4MM…Arthrex, Inc.200437—
+3K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+3K071622Arthrex FiberwireArthrex, Inc.20073—
+3K041553Arthrex Suture Grafting KitArthrex, Inc.200431—
+4K252225PowerKnot High Strength SuturesMedacta International S.A.20250—
+4K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+4K213046AceConnex Pre-Sutured FasciaAllosource20230—
+4K212146Arthrex LoopLoc Knotless SutureArthrex, Inc.20210—
+4K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+4K181633MTF Pre-Sutured TendonMusculoskeletal Transplant Foundation201921
+4K181182DYNACORD SutureMedos International SARL20181—
+4K170957ReConnex Pre-Sutured TendonAllosource20183—
+4K130458Knotless Fibertak Suture AnchorArthrex, Inc.20132—
+4K123668OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company20130—
+4K122374Arthrex Suture (Uhmwpe)Arthrex, Inc.201213—
+4K112899Arthrex Bio-SutureArthrex, Inc.20123—
+4K080918Double Armed Meniscal Needles with Size #2-0 Orthocord, Meniscal Needle with Wire Eyelet…Depuy Mitek20080—
+5K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.20260—
+5K260018Arthrex FiberButtonArthrex, Inc.20260—
+5K260405FiberTape ButtonArthrex, Inc.20260—
+5K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical20251—
+5K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+5K230036Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple…Rti Surgical, Inc.20231—
+5K223822Activbraid™Embody, Inc.20230—
+5K220880Arthrex BioSutureArthrex, Inc.20220—
+5K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+5K203186DYNATAPE SutureMedos International SARL20210—
+5K190777DemeTECH DemeFORCE Nonabsorbable Surgical SutureDemetech Corporation20190—
+5K171296SutureTapeArthrex, Inc.20173—
+5K160854MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation SutureBiomet Manafacturing Corp.20160—
+5K152868ExpressBraid Graft ManipulationBiomet Manufacturing Corp20162—
+5K140019Arthrex BiosutureArthrex, Inc.20141—
+6K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+6K253145Pre-Sutured TendonRti Surgical, Inc.20250—
+6K240487EVOS Patella PlatesSmith & Nephew20240—
+6K221354Arthrex SutureTapeArthrex, Inc.20220—
+6K193575Arthrex SutureTapeArthrex, Inc.20201—
+6K163651ExpressBraid Graft ManipulationBiomet Manufacturing Corp20170—