510(k) Report

Devices descending from K040537

70 later devices reach Ams Apogee Vault Suspension System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083722AscendCaldera Medical, Inc.20097—
+1K071512Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc.200820—
+1K053371Ams Male Transobturator Sling SystemAmerican Medical Systems, Inc.2006103
+1K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.200517—
+1K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc.2005301
+2K182169AdVance XP Male SlingBoston Scientific Corporation20182—
+2K102815Surelift Prolapse SystemNeomedic International20110—
+2K101462Ascend Blue AC Mesh; Ascend Blue PC MeshCaldera Medical, Inc.20106—
+2K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc.200913—
+2K083499Exair Anterior and Posterior Prolapse Repair SystemsColoplast A/S20091—
+2K082677Ams Elevate Anterior & Apical Prolapse Repair System with Intepro LiteAmerican Medical Systems, Inc.200811
+2K082387Apogee and Perigee Systems with Intepro Lite and Intexen LP, Part of the Ams; Pelvic…American Medical Systems20080—
+2K082640Virtue Ventral Urethral Elevation Sling SystemColoplast Manufacturing Us, LLC20085—
+2K081710Apogee and Perigee Systems with PC Coated Intepro LiteAmerican Medical Systems20080—
+2K082216TBD Ethicon MeshETHICON, Inc.20081—
+2K081048Pinnacle Pelvic Floor Repair Kit IIBoston Scientific Corp200861
+2K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+2K080185Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen LP…American Medical Systems, Inc.200811—
+2K070993Topas SystemAmerican Medical Systems, Inc.20071—
+2K063079I-Stop Trans Obturator Male SlingCl Medical20060—
+2K062320Surgisis Peyronie's Repair Graft, Model SPR-100Cook Biotech, Inc.20061—
+3K211847AdVance XP Male Sling SystemBoston Scientific Corporation20211—
+3K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated201601
+3K121612Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationAmerican Medical Systems20120—
+3K113205Artisyn Y-Shaped MeshETHICON, Inc.20120—
+3K112322Restorelle Polypropylene Y MeshColoplast A/S20126—
+3K120327VertessaCaldera Medical, Inc.20125—
+3K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+3K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp20114—
+3K112386Exair Anterior and Posterior Prolapse Repair SystemColoplast Corp.20110—
+3K103568Restorelle Polypropylene Mesh; Restorelle Polypropylene MeshColoplast A/S201001
+3K101297Virtue Ventral Urethral Elevation Sling System Model 50020Coloplast A/S20103—
+3K090934PFR Sling System, Part of the Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.20090—
+3K091131Pelvic Floor Repair SystemBoston Scientific20095—
+3K091152Virtue Ventral Urethral Elevation Sling System, Model 50020Coloplast A/S20094—
+3K090288Orthadapt PRPegasus Biologics, Inc.20097—
+3K082730Ams Elevate Apical and Posterior Prolapse Repair System with Intepro Lite, Ams Elevate…American Medical Systems, Inc.20081—
+4K242960AdVance™ XP Male Sling System (720163-03)Boston Scientific Corporation20240—
+4K151083BioBridge Collagen MatrixFibralign Corporation20169—
+4K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+4K123028Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc.20131—
+4K123914Restorelle Y ContourColoplast A/S20132—
+4K123337Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CMCaldera Medical20131—
+4K122794Upsylon Y MeshBoston Scientific Corp20120—
+4K122968Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015Coloplast Corp.20120—
+4K122459Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemBoston Scientific Corporation201222
+4K122440Restorelle LColoplast Corp.201211
+4K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+4K113496Virture Male Sling System with Alexis Wound Retractor Convenience KitColoplast A/S20121—
+4K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+4K111881Virtue Male Sling System and Alexis (R) Wound Retractor KitColoplast A/S20110—
+5K231891Virtue Male Sling System with Alexis Wound Retractor Convenience KitColoplast20230—
+5K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+5K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+5K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+5K172060Capio SLIM Suture Capturing DeviceBoston Scientific Corporation201714
+5K150023Vertessa Lite Y-MeshCaldera Medical, Inc.20150—
+5K150016Vertessa LiteCaldera Medical, Inc.20150—
+5K140116Restorelle Y Contour MeshColoplast A/S20141—
+5K132061Restorelle M, Restorelle XLColoplast Corp.20130—
+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—
+6K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+6K173527Digitex Delivery DeviceColoplast A/S20180—
+6K173501Meridian Vaginal Positioning System (VPS)Coloplast20180—
+7K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+7K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—