510(k) Report

Devices descending from K040538

39 later devices reach Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051530Monarc + Subfascial Hammock, Model 72404193; Monarc C Subfascial Hammock, Model 72404195.American Medical Systems, Inc.200561
+1K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc.2005301
+1K041948Sparc, Monarc, Bioarc SP and Bioarc to Sling SystemsAmerican Medical Systems, Inc.200437—
+2K081613Sparc System / Monarc, Monarc C, Monarc + SystemsAmerican Medical Systems, Inc.20085—
+2K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+2K062320Surgisis Peyronie's Repair Graft, Model SPR-100Cook Biotech, Inc.20061—
+2K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.200517—
+3K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated201601
+3K131229Sparc System and Monarc, Monarc, and Monarc C SystemsAmerican Medical Systems201301
+3K132655Retroarc Retropubic Sling SystemAmerican Medical Systems, Inc.20133—
+3K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+3K082677Ams Elevate Anterior & Apical Prolapse Repair System with Intepro LiteAmerican Medical Systems, Inc.200811
+3K082387Apogee and Perigee Systems with Intepro Lite and Intexen LP, Part of the Ams; Pelvic…American Medical Systems20080—
+3K081710Apogee and Perigee Systems with PC Coated Intepro LiteAmerican Medical Systems20080—
+3K080185Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen LP…American Medical Systems, Inc.200811—
+3K070993Topas SystemAmerican Medical Systems, Inc.20071—
+4K183134ArcTV Transvaginal Sling SystemUrocure, LLC20192—
+4K151083BioBridge Collagen MatrixFibralign Corporation20169—
+4K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+4K121612Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationAmerican Medical Systems20120—
+4K102815Surelift Prolapse SystemNeomedic International20110—
+4K090934PFR Sling System, Part of the Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.20090—
+4K090288Orthadapt PRPegasus Biologics, Inc.20097—
+4K082730Ams Elevate Apical and Posterior Prolapse Repair System with Intepro Lite, Ams Elevate…American Medical Systems, Inc.20081—
+5K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+5K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+5K222293ArcSP Suprapubic Sling SystemUrocure, LLC20220—
+5K222468ArcTO Transobturator Sling SystemUrocure, LLC20220—
+5K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+5K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+6K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+6K260317Artelon Convenience KitsInternational Life Sciences20260—
+6K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+6K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+6K242187BioBrace®Conmed Corporation20241—
+6K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+7K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+7K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+7K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—