Devices descending from K830889
307 later devices reach Dexon 'S' Polyglycolic Acid Mesh through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K053066 | Sepramesh IP Bioresorbable Coating/Permanent Mesh | Genzyme Corporation | 2005 | 17 | — |
| +1 | K040868 | Sepramesh IP Bioresorbable Barrier - Permanent Mesh | Genzyme Corp. | 2004 | 34 | — |
| +1 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | 284 | — |
| +1 | K963619 | Gore-Tex Soft Tissue Patch,Mycromesha Biomaterial,Dualmesh Biomaterial,Dualmesh… | W. L. Gore & Associates, Inc. | 1996 | 0 | — |
| +2 | K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix… | Cook Biotech Incorporated | 2019 | 4 | — |
| +2 | K160181 | Colorado Therapeutics Xenograft Implant | Colorado Therapeutics, LLC | 2016 | 1 | — |
| +2 | K160869 | Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft | Cook Biotech Incorporated | 2016 | 0 | 1 |
| +2 | K140306 | Cormatrix Protect Ecm Envelope | Cormatrix Cardiovascular, Inc. | 2014 | 4 | 2 |
| +2 | K134033 | Miromatrix Biological Mesh | Miromatrix Medical, Inc. | 2014 | 2 | — |
| +2 | K130547 | Endoform Reconstructive Template | Mesynthe, Ltd. | 2013 | 5 | — |
| +2 | K111695 | Hybrid Graft | Cook Biotech, Inc. | 2012 | 0 | — |
| +2 | K110402 | Biodesign Nipple Reconstruction Cylinder | Cook Biotech, Inc. | 2011 | 0 | — |
| +2 | K101928 | Ventralex ST Hernia Patch | C.R. Bard, Inc. | 2011 | 1 | 1 |
| +2 | K101920 | Ventrio ST Hernia Patch | C.R. Bard, Inc. | 2011 | 3 | — |
| +2 | K101851 | Ventralight ST Mesh | Davol Inc., Sub. C. R. Bard, Inc. | 2010 | 10 | 2 |
| +2 | K090688 | Cook Urological Graft | Cook Biotech, Inc. | 2009 | 0 | — |
| +2 | K082079 | Regen Collagen Scaffold (CS) | Regen Biologics, Inc. | 2008 | 2 | — |
| +2 | K063349 | Cormatrix Patch for Cardiac Tissue Repair | Cormatrix Cardiovascular, Inc. | 2007 | 11 | — |
| +2 | K063739 | Sepramesh, Model 5959-1214 | Genzyme Corporation | 2007 | 16 | — |
| +2 | K062915 | Veritas Collagen Matrix | Synovis Surgical Innovations | 2006 | 15 | 1 |
| +2 | K062320 | Surgisis Peyronie's Repair Graft, Model SPR-100 | Cook Biotech, Inc. | 2006 | 1 | — |
| +2 | K053622 | Surgisis Ocular Graft | Iop, Inc. | 2006 | 2 | — |
| +2 | K051048 | Surgisis Staple Line Reinforcement II | Cook Biotech, Inc. | 2005 | 3 | — |
| +2 | K051405 | Regensis Pericardial Patch | Cormatrix Cardiovascular, Inc. | 2005 | 15 | — |
| +2 | K050246 | Sis Dermal Augmentation Strand | Cook Biotech, Inc. | 2005 | 4 | — |
| +2 | K050337 | Sis Fistula Plug | Cook Biotech, Inc. | 2005 | 27 | — |
| +2 | K043366 | Permacol Surgical Implant | Tissue Science Laboratories, Plc | 2004 | 74 | — |
| +2 | K040621 | Acell Ubm Surgical Mesh | Acell, Inc. | 2004 | 5 | — |
| +2 | K034039 | Sis Plastic Surgery Matrix | Cook Biotech, Inc. | 2004 | 93 | — |
| +2 | K031850 | Durasis Dural Substitute | Cook Biotech, Inc. | 2003 | 2 | — |
| +2 | K031069 | Surgisis Nerve Cuff | Cook Biotech, Inc. | 2003 | 10 | — |
| +2 | K021056 | Permacol | Tissue Science Laboratories, Plc | 2002 | 51 | — |
| +2 | K022044 | Surgisis Staple Line Reinforcement | Cook Biotech, Inc. | 2002 | 6 | — |
| +2 | K021105 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | 42 | — |
| +2 | K020455 | Tissuemend Soft Tissue Repair Matrix | Tei Biosciences, Inc. | 2002 | 56 | — |
| +2 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | 173 | — |
| +2 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | 204 | — |
| +2 | K982330 | Depuy Orthotech Restore Orthobiologic Soft Tissue Implant | Depuy, Inc. | 1998 | 92 | — |
| +3 | K243241 | Phasix ST Umbilical Hernia Patch | Davol, Inc., A Subsidiary of C.R. Bard, Inc. | 2025 | 0 | — |
| +3 | K210331 | CardiaMend Pericardial and Epicardial Reconstruction Matrix | Helios Cardio, Inc. | 2021 | 0 | — |
| +3 | K202430 | Kerecis Reconstruct | Kerecis Limited | 2021 | 3 | — |
| +3 | K191734 | MatriStem UBM Pericardial Patch | Acell, Inc. | 2019 | 0 | — |
| +3 | K190185 | Phasix ST Mesh with Open Positioning System | C.R. Bard, Inc. | 2019 | 1 | — |
| +3 | K173242 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)… | Aziyo Biologics, Inc. | 2017 | 3 | 1 |
| +3 | K172937 | Colorado Therapeutics Xenograft Implant | Colorado Therapeutics, LLC | 2017 | 0 | — |
| +3 | K162934 | Biodesign Parastomal Hernia Repair Graft | Cook Biotech Incorporated | 2017 | 1 | — |
| +3 | K170016 | Biodesign Fistula Plug | Cook Biotech Incorporated | 2017 | 5 | — |
| +3 | K170364 | Collagen Meniscus Implant XL | Ivy Sports Medicine, LLC | 2017 | 1 | — |
| +3 | K163217 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | 2017 | 5 | — |
| +3 | K162388 | CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF) | Curaseal, Inc. | 2017 | 0 | — |
| +3 | K162461 | Endoform Plastics and Reconstructive Matrix | Aroa Biosurgery (Formerly Mesynthes Limited) | 2016 | 0 | — |
| +3 | K162741 | AxoGuard Nerve Connector | Cook Biotech Incorporated | 2016 | 2 | — |
| +3 | K161221 | Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug | Cook Biotech Incorporated | 2016 | 6 | — |
| +3 | K153633 | Endoform Reconstructive Template | Aroa Biosurgery Limited (Formerly Mesynthes Limited) | 2016 | 1 | 21 |
| +3 | K152127 | CorMatrix Tyke | Cormatrix Cardiovascular, Inc. | 2016 | 2 | — |
| +3 | K141084 | Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix | Acell, Inc. | 2015 | 3 | — |
| +3 | K143380 | Phasix ST Mesh | C.R. Bard, Inc. | 2015 | 4 | — |
| +3 | K150341 | Miromatrix Biological Mesh RS | Miromatrix Medical, Inc. | 2015 | 1 | — |
| +3 | K141721 | Bovine Pericardium Patch | Collafirm, LLC | 2014 | 0 | — |
| +3 | K141053 | Ovine Tissue Matrix (Otm) | TELA Bio, Inc. | 2014 | 2 | — |
| +3 | K141560 | Ethicon Physiomesh Open Flexible Composite Mesh Device | ETHICON, Inc. | 2014 | 0 | — |
| +3 | K140789 | Cormatrix Ecm for Vascular Repair | Cormatrix Cardiovascular, Inc. | 2014 | 0 | — |
| +3 | K133011 | Diaphragmatic Hernia Graft | Cook Biotech, Inc. | 2014 | 1 | 1 |
| +3 | K130557 | Neuragen 3D | Integra LifeSciences Corporation | 2014 | 1 | — |
| +3 | K132660 | Nerve Cuff | Cook Biotech Incorporated | 2014 | 6 | — |
| +3 | K131015 | Biodesign Onlay Dural Graft or Biodesign Duraplasty Graft | Cook Biotech, Inc. | 2013 | 0 | — |
| +3 | K130006 | Biodesign Surgisis Anterior Posterior Pelvic Floor Grafts | Cook Biotech Incorporated | 2013 | 0 | — |
| +3 | K122306 | Synovis Collagen Matrix (TBD) | Synovis Surgical Innovations | 2013 | 0 | — |
| +3 | K120605 | Permacol Surgical Implant | Covidien, LLC | 2012 | 4 | — |
| +3 | K113460 | Synergy Tissue Matrix | Synovis Orthopedic & Woundcare | 2012 | 0 | — |
| +3 | K111187 | Patch, Pledget and Intracardiac | Cormatrix Cardiovascular, Inc. | 2011 | 1 | — |
| +3 | K110820 | Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System | C.R. Bard, Inc. | 2011 | 5 | — |
| +3 | K094061 | Kensey Nash Ecm Surgical Patch | Kensey Nash Corporation | 2010 | 10 | — |
| +3 | K090637 | Cardio-Wrap | Mast Biosurgery USA, Inc. | 2010 | 0 | — |
| +3 | K090078 | Kerasys Bioengineered Lamellar Patch Graft | Iop, Inc. | 2009 | 1 | — |
| +3 | K083266 | Gore Bio-a Fistula Plug | W. L. Gore & Associates, Inc. | 2009 | 12 | — |
| +3 | K083823 | Securian Tissue Reinforcement Matrix | Xylos Corporation | 2009 | 9 | — |
| +3 | K082682 | Surgisis Biodesign Enterocutaneous Fistula Plug | Cook Biotech, Inc. | 2009 | 1 | — |
| +3 | K083039 | Veritas Collagen Matrix (Dry) | Synovis Surgical Innovations | 2008 | 2 | — |
| +3 | K080442 | Seriscaffold Surgical Mesh | Serica Technologies, Inc. | 2008 | 14 | 1 |
| +3 | K081438 | Matracell Decellularized Pulmonary Artery Patch Allograft | Lifenet Health | 2008 | 0 | — |
| +3 | K073391 | Surgisis Biodesign Tissue Graft | Cook Biotech, Inc. | 2008 | 8 | — |
| +3 | K071986 | LTM-RC Surgical Mesh | Lifecell Corp. | 2007 | 3 | — |
| +3 | K070405 | Modification to Surgisis SLR Staple Line Reinforcement | Cook Biotech, Inc. | 2007 | 2 | — |
| +3 | K071555 | Fortagen Oral Membrane | Organogenesis, Inc. | 2007 | 1 | — |
| +3 | K071807 | Orthomend Soft Tissue Matrix | Tei Biosciences, Inc. | 2007 | 17 | 4 |
| +3 | K070560 | LRTM Surgical Mesh | Lifecell Corp. | 2007 | 50 | 2 |
| +3 | K061892 | Propatch Soft Tissue Repair Matrix | Cryolife, Inc. | 2006 | 17 | — |
| +3 | K062729 | Surgisis RVP Recto-Vaginal Fistula Plug | Cook Biotech, Inc. | 2006 | 0 | 12 |
| +3 | K053562 | Zimmer Collagen Repair Patch | Tissue Science Laboratories, Plc | 2006 | 41 | — |
| +3 | K060829 | Cosmatrix | Tei Biosciences, Inc. | 2006 | 18 | — |
| +3 | K052830 | Sportmesh | Artimplant AB | 2006 | 44 | — |
| +3 | K043388 | Pegasus Biologics Orthadapt Surgical Mesh | Pegasus Biologics, Inc. | 2005 | 49 | — |
| +3 | K050445 | Ams Collagen Dermal Matrix | American Medical Systems, Inc. | 2005 | 30 | 1 |
| +3 | K051190 | Xenform Soft Tissue Repair Matrix | Tei Biosciences, Inc. | 2005 | 1 | — |
| +3 | K050355 | Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models… | Tissue Science Laboratories, Plc | 2005 | 54 | — |
| +3 | K041140 | Acell Ubm Surgical Mesh ML and Mlplus | Acell, Inc. | 2004 | 4 | — |
| +3 | K033671 | Gore Bioabsorbable Mesh | W. L. Gore & Associates, Inc. | 2003 | 39 | — |
| +3 | K031969 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2003 | 91 | — |
| +3 | K031188 | Orthomend | Tei Biosciences, Inc. | 2003 | 36 | — |