510(k) Report

Devices descending from K001122

152 later devices reach Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated201601
+5K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+5K150023Vertessa Lite Y-MeshCaldera Medical, Inc.20150—
+5K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+5K140116Restorelle Y Contour MeshColoplast A/S20141—
+5K131007Aigis RX N Medium; Aigis RX N LargeTyrx, Inc.20136—
+5K130943Aigis RX R PM/ Aigis RX R IcdTyrx, Inc.201314—
+5K121612Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationAmerican Medical Systems20120—
+5K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+5K112386Exair Anterior and Posterior Prolapse Repair SystemColoplast Corp.20110—
+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—
+5K091131Pelvic Floor Repair SystemBoston Scientific20095—
+5K091152Virtue Ventral Urethral Elevation Sling System, Model 50020Coloplast A/S20094—
+5K090288Orthadapt PRPegasus Biologics, Inc.20097—
+5K082730Ams Elevate Apical and Posterior Prolapse Repair System with Intepro Lite, Ams Elevate…American Medical Systems, Inc.20081—
+6K242960AdVance™ XP Male Sling System (720163-03)Boston Scientific Corporation20240—
+6K182087DynaMesh-POSTERIORFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft20180—
+6K180030TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope…Medtronic, Inc.20183—
+6K173527Digitex Delivery DeviceColoplast A/S20180—
+6K173501Meridian Vaginal Positioning System (VPS)Coloplast20180—
+6K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+6K151083BioBridge Collagen MatrixFibralign Corporation20169—
+6K142611TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc.20144—
+6K132699Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc.20135—
+6K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+6K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+6K113496Virture Male Sling System with Alexis Wound Retractor Convenience KitColoplast A/S20121—
+6K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+6K111881Virtue Male Sling System and Alexis (R) Wound Retractor KitColoplast A/S20110—
+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—
+7K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+7K192389TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope…Medtronic, Inc.20202—
+7K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+7K152678TYRX Neuro Antibacterial EnvelopeTyrx, Inc.20150—
+7K150291TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc.20153—
+8K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+8K260317Artelon Convenience KitsInternational Life Sciences20260—
+8K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+8K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+8K242187BioBrace®Conmed Corporation20241—
+8K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.20241—
+8K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+8K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+8K180122TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable…Medtronic, Inc.20181—
+9K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+9K262406EluPro Antibiotic-Eluting BioEnvelopeBoston Scientific20260—
+9K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+9K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—
+9K192636TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable…Medtronic, Inc.20200—