510(k) Report

Devices descending from K051485

17 later devices reach Ams Pelvic Floor Repair System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082677Ams Elevate Anterior & Apical Prolapse Repair System with Intepro LiteAmerican Medical Systems, Inc.200811
+1K082387Apogee and Perigee Systems with Intepro Lite and Intexen LP, Part of the Ams; Pelvic…American Medical Systems20080—
+1K081710Apogee and Perigee Systems with PC Coated Intepro LiteAmerican Medical Systems20080—
+1K080185Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen LP…American Medical Systems, Inc.200811—
+1K070993Topas SystemAmerican Medical Systems, Inc.20071—
+2K121612Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationAmerican Medical Systems20120—
+2K102815Surelift Prolapse SystemNeomedic International20110—
+2K090934PFR Sling System, Part of the Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.20090—
+2K090288Orthadapt PRPegasus Biologics, Inc.20097—
+2K082730Ams Elevate Apical and Posterior Prolapse Repair System with Intepro Lite, Ams Elevate…American Medical Systems, Inc.20081—
+3K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+3K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+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—