510(k) Report

Devices descending from K041553

31 later devices reach Arthrex Suture Grafting Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213046AceConnex Pre-Sutured FasciaAllosource20230—
+1K212146Arthrex LoopLoc Knotless SutureArthrex, Inc.20210—
+1K181633MTF Pre-Sutured TendonMusculoskeletal Transplant Foundation201921
+1K181182DYNACORD SutureMedos International SARL20181—
+1K170957ReConnex Pre-Sutured TendonAllosource20183—
+1K130458Knotless Fibertak Suture AnchorArthrex, Inc.20132—
+1K123668OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company20130—
+1K122374Arthrex Suture (Uhmwpe)Arthrex, Inc.201213—
+1K112899Arthrex Bio-SutureArthrex, Inc.20123—
+1K071622Arthrex FiberwireArthrex, Inc.20073—
+2K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.20260—
+2K260018Arthrex FiberButtonArthrex, Inc.20260—
+2K260405FiberTape ButtonArthrex, Inc.20260—
+2K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical20251—
+2K252225PowerKnot High Strength SuturesMedacta International S.A.20250—
+2K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+2K230036Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple…Rti Surgical, Inc.20231—
+2K223822Activbraid™Embody, Inc.20230—
+2K220880Arthrex BioSutureArthrex, Inc.20220—
+2K203186DYNATAPE SutureMedos International SARL20210—
+2K190777DemeTECH DemeFORCE Nonabsorbable Surgical SutureDemetech Corporation20190—
+2K171296SutureTapeArthrex, Inc.20173—
+2K160854MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation SutureBiomet Manafacturing Corp.20160—
+2K152868ExpressBraid Graft ManipulationBiomet Manufacturing Corp20162—
+2K140019Arthrex BiosutureArthrex, Inc.20141—
+2K080918Double Armed Meniscal Needles with Size #2-0 Orthocord, Meniscal Needle with Wire Eyelet…Depuy Mitek20080—
+3K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+3K253145Pre-Sutured TendonRti Surgical, Inc.20250—
+3K221354Arthrex SutureTapeArthrex, Inc.20220—
+3K193575Arthrex SutureTapeArthrex, Inc.20201—
+3K163651ExpressBraid Graft ManipulationBiomet Manufacturing Corp20170—