510(k) Report

Devices descending from K060989

13 later devices reach Tissuemend Soft Tissue Repair Matrix through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc.200712—
+2K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+2K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery200810—
+3K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+3K090778Mta Protective SheetXylos Corporation20092—
+3K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+4K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+4K100984Xylos Vessel GuardXylos Corporation20100—
+5K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+6K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+6K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+6K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+7K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—