510(k) Report

Devices descending from K132043

6 later devices reach Arthrex Speedcinch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190707Arthrex SoftStitchArthrex, Inc.20202—
+1K190125FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd.20192—
+2K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+2K222078Arthrex SoftStitchArthrex, Inc.20220—
+2K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd.20221—
+3K244015SuperBall-RC™Arcuro Medical, Ltd.20250—