510(k) Report

Devices descending from K053215

13 later devices reach Surgical Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081377Nuvasive Surgical Mesh SystemNuvasive, Inc.20090—
+1K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+2K211563Pitch-PatchsXiros, Ltd.20212—
+2K090288Orthadapt PRPegasus Biologics, Inc.20097—
+3K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…ZuriMED Technologies AG20241—
+3K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+3K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+4K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG20260—
+4K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+5K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+5K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+5K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+6K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—