510(k) · Cleared
ClearedGORE BIO-A Tissue Reinforcement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · OWT Mesh, Surgical, Absorbable, Abdominal Hernia
Cleared on Jul 31, 2019 as substantially equivalent to K163217 (W. L. Gore & Associates, Inc., 2017) after a 29-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- Jul 31, 2019
- Review
- 29 days
- Class
- Class II
- Product code
- OWT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K921895 (1992). 53 ancestors in all, the oldest K810428 (1981). No later device cites it as a predicate yet.
- Root · 9 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 5 generations between
- 3 generations backK094061 Kensey Nash Ecm Surgical PatchKensey Nash Corporation · 2010
- 2 generations backK132025 Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical · 2013
- 1 generation backK163217 GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc. · 2017
- This deviceK191773 GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc. · 2019
Show all 9 generations
- Root · 9 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 8 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 7 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 6 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 5 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 4 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 3 generations backK094061 Kensey Nash Ecm Surgical PatchKensey Nash Corporation · 2010
- 2 generations backK132025 Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical · 2013
- 1 generation backK163217 GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc. · 2017
- This deviceK191773 GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −8 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −7 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −6 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −5 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −4 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −3 | K094061 | Kensey Nash Ecm Surgical Patch | Kensey Nash Corporation | 2010 | — |
| −2 | K132025 | Meso Bilayer Surgical Mesh | Kensey Nash Corporation Dba Dsm Biomedical | 2013 | — |
| −1 | K163217 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | 2017 | — |
| 0 (this device) | K191773 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OWT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OWT device
- #1 K261543 Phasix ST Parastomal Hernia Meshscore 13.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K163217 | GORE BIO-A Tissue ReinforcementSummary page 4…Regulation: 21CFR 878.3300 Classification: Class II Product Code: OWT, OWZ, OXC, OXF Predicate Devices • K163217 GORE® BIO-A® Tissue Reinforcement Device Description The subject GORE® BIO-A® Tissue Reinforcement is a bioabsorbable web struc… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 53 ancestors have a recall of any class.
- 2 other devices also cite its predicate K163217.
How does its category compare?
All OWT devicesOWT Mesh, Surgical, Absorbable, Abdominal Hernia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OWT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWT
Too few OWT 510(k)s in any year since 2007 to give a median.
Recalls per year · OWT
No recall names OWT since 2007.
Adverse event reports per year · OWT
82in 2025
MAUDE reports naming product code OWT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 7 |
| 2018 | 1 | — | 0 | 31 |
| 2019 | 2 | — | 0 | 61 |
| 2020 | 1 | — | 0 | 45 |
| 2021 | 0 | — | 0 | 58 |
| 2022 | 0 | — | 0 | 104 |
| 2023 | 0 | — | 0 | 76 |
| 2024 | 1 | — | 0 | 65 |
| 2025 | 1 | — | 0 | 82 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
GORE® BIO-A® Tissue Reinforcement is intended for use in the reinforcement of soft tissue. This includes use in patients requiring soft tissue reinforcement in plastic and reconstructive surgery.
Examples of applications where GORE® BIO-A® Tissue Reinforcement may be used include:
-Hernia repair as suture line reinforcement
-Muscle flap reinforcement
-General tissue reconstructions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191773 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191773: GORE BIO-A Tissue Reinforcement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191773
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026