510(k) Report

Devices descending from K080185

11 later devices reach Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102815Surelift Prolapse SystemNeomedic International20110—
+1K090288Orthadapt PRPegasus Biologics, Inc.20097—
+1K082730Ams Elevate Apical and Posterior Prolapse Repair System with Intepro Lite, Ams Elevate…American Medical Systems, Inc.20081—
+2K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+2K121612Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationAmerican Medical Systems20120—
+2K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+3K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+4K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+4K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+4K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+5K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—