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. · OXF Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
Cleared on Feb 10, 2017 as substantially equivalent to K034039 (Cook Biotech, Inc., 2004) and 2 other predicates after an 86-day review. Its family tree reaches back 8 generations to 1992. 5 later devices descend from it.
- Decided
- Feb 10, 2017
- Review
- 86 days
- Class
- Class II
- Product code
- OXF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K921895 (1992). 52 ancestors in all, the oldest K810428 (1981). 5 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 7 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 6 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 5 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 4 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 3 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 2 generations backK094061 Kensey Nash Ecm Surgical PatchKensey Nash Corporation · 2010
- 1 generation backK132025 Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical · 2013
- This deviceK163217 GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK232602 3DMatrix Surgical MeshPrintbio, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK173333 GORE ENFORM BiomaterialW. L. Gore & Associates, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK243302 3DMatrix DynaFlex (DynaFlex)Printbio, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK222919 GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK191773 GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K2326023DMatrix Surgical MeshPrintbio, Inc. · 2024 · cites it directly1descendant
- K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc. · 2018 · cites it directly1descendant
- K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc. · 2025 · 2 generations on0descendants
- K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc. · 2022 · 2 generations on0descendants
- K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −7 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −6 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −5 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −4 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −3 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −2 | K094061 | Kensey Nash Ecm Surgical Patch | Kensey Nash Corporation | 2010 | — |
| −1 | K132025 | Meso Bilayer Surgical Mesh | Kensey Nash Corporation Dba Dsm Biomedical | 2013 | — |
| 0 (this device) | K163217 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | 2017 | — |
| +1 | K232602 | 3DMatrix Surgical Mesh | Printbio, Inc. | 2024 | — |
| +1 | K173333 | GORE ENFORM Biomaterial | W. L. Gore & Associates, Inc. | 2018 | — |
| +2 | K243302 | 3DMatrix DynaFlex (DynaFlex) | Printbio, Inc. | 2025 | — |
| +2 | K222919 | GORE® ENFORM Biomaterial | W. L. Gore and Associates, Inc. | 2022 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 OXF? 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 OXF device
- #1 K232602 3DMatrix Surgical Meshscore 12.8 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K034039 | Sis Plastic Surgery MatrixSummary page 4…esh, surgical, polymeric Classification: 21CFR878.3300 Product Code: OXF, OWT, OWZ, OXC Predicate Devices x K034039 Cook SIS Plastic Surgery Matrix x K033671 Gore Bioabsorbable Mesh x K132025… | 2004 |
| * | K033671 | Gore Bioabsorbable MeshSummary page 4…on: 21CFR878.3300 Product Code: OXF, OWT, OWZ, OXC Predicate Devices x K034039 Cook SIS Plastic Surgery Matrix x K033671 Gore Bioabsorbable Mesh x K132025 MESO Bilayer Surgical Mesh Device Description The subject G… | 2003 |
| * | K132025 | Meso Bilayer Surgical MeshSummary page 4…e: OXF, OWT, OWZ, OXC Predicate Devices x K034039 Cook SIS Plastic Surgery Matrix x K033671 Gore Bioabsorbable Mesh x K132025 MESO Bilayer Surgical Mesh Device Description The subject GORE® BIO-A® Tissue Reinforcement is a bioabsorbable web… | 2013 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 7 companies; a new generation was cleared every 3.3 years on median.
- 3 of the 52 ancestors have a recall of any class.
- Of its descendants, K232602 (Printbio, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 11 other devices also cite its predicate K034039.
How does its category compare?
All OXF devicesOXF Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OXF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OXF
Too few OXF 510(k)s in any year since 2007 to give a median.
Recalls per year · OXF
No recall names OXF since 2007.
Adverse event reports per year · OXF
1in 2023
MAUDE reports naming product code OXF, 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 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 14 |
| 2014 | 0 | — | 0 | 129 |
| 2015 | 0 | — | 0 | 107 |
| 2016 | 0 | — | 0 | 52 |
| 2017 | 2 | — | 0 | 25 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 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/K163217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163217: GORE BIO-A Tissue Reinforcement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163217
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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