510(k) Report

Devices descending from K013718

153 later devices reach Gynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic Surgical Mesh… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated201601
+5K150091Versatex Monofilament MeshSofradim Production201542
+5K150023Vertessa Lite Y-MeshCaldera Medical, Inc.20150—
+5K142900Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug…Sofradim Production20145—
+5K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+5K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+5K140941Progrip Self-Gripping Polypropylene Mesh, Parietene Flat Sheet MeshSofradim Production20145—
+5K140116Restorelle Y Contour MeshColoplast A/S20141—
+5K133938Endo Gia Reinforced Reload with Tri-Staple TechnologyCovidien20141—
+5K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+5K121612Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationAmerican Medical Systems20120—
+5K120327VertessaCaldera Medical, Inc.20125—
+5K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+5K112567Biomerix AssureBiomerix Corporation20110—
+5K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+5K101297Virtue Ventral Urethral Elevation Sling System Model 50020Coloplast A/S20103—
+5K090934PFR Sling System, Part of the Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.20090—
+5K091152Virtue Ventral Urethral Elevation Sling System, Model 50020Coloplast A/S20094—
+5K082730Ams Elevate Apical and Posterior Prolapse Repair System with Intepro Lite, Ams Elevate…American Medical Systems, Inc.20081—
+6K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+6K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production20250—
+6K243315ProGrip™ Self-Gripping Polypropylene MeshSofradim Production20251—
+6K242960AdVance™ XP Male Sling System (720163-03)Boston Scientific Corporation20240—
+6K220540ProGrip Self-Gripping Polypropylene MeshCovidien20220—
+6K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…Synovis Life Technologies. Inc. (A Subsidiary of Baxter20210—
+6K173270Tri-Staple 2.0 Reinforced ReloadCovidien201802
+6K173501Meridian Vaginal Positioning System (VPS)Coloplast20180—
+6K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+6K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+6K151083BioBridge Collagen MatrixFibralign Corporation20169—
+6K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+6K143386Progrip Laparoscopic Self-Fixating MeshSofradim Production20150—
+6K142091Parietene Macroporous MeshSofradim Production20142—
+6K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+6K123337Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CMCaldera Medical20131—
+6K122440Restorelle LColoplast Corp.201211
+6K113496Virture Male Sling System with Alexis Wound Retractor Convenience KitColoplast A/S20121—
+6K111881Virtue Male Sling System and Alexis (R) Wound Retractor KitColoplast A/S20110—
+7K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production20260—
+7K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim Production20250—
+7K231891Virtue Male Sling System with Alexis Wound Retractor Convenience KitColoplast20230—
+7K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+7K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+7K223218Parietene Macroporous MeshSofradim Production20221—
+7K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+7K150016Vertessa LiteCaldera Medical, Inc.20150—
+7K132061Restorelle M, Restorelle XLColoplast Corp.20130—
+8K260317Artelon Convenience KitsInternational Life Sciences20260—
+8K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+8K242187BioBrace®Conmed Corporation20241—
+8K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+9K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+9K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—