510(k) Report

Devices descending from K083823

9 later devices reach Securian Tissue Reinforcement Matrix through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+1K090778Mta Protective SheetXylos Corporation20092—
+2K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+2K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+2K100984Xylos Vessel GuardXylos Corporation20100—
+3K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+3K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+3K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+4K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—