510(k) · Cleared
ClearedGORE® ENFORM Biomaterial
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore and Associates, Inc. · OXF Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
Cleared on Dec 19, 2022 as substantially equivalent to K173333 (W. L. Gore & Associates, Inc., 2018) and 1 other predicate after an 84-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- Dec 19, 2022
- Review
- 84 days
- Class
- Class II
- Product code
- OXF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K921895 (1992). 82 ancestors in all, the oldest K810428 (1981). No later device cites it as a predicate yet.
- Root · 10 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 6 generations between
- 3 generations backK132025 Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical · 2013
- 2 generations backK163217 GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc. · 2017
- 1 generation backK173333 GORE ENFORM BiomaterialW. L. Gore & Associates, Inc. · 2018
- This deviceK222919 GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc. · 2022
Show all 10 generations
- Root · 10 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 9 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 8 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 7 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 6 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 5 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 4 generations backK094061 Kensey Nash Ecm Surgical PatchKensey Nash Corporation · 2010
- 3 generations backK132025 Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical · 2013
- 2 generations backK163217 GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc. · 2017
- 1 generation backK173333 GORE ENFORM BiomaterialW. L. Gore & Associates, Inc. · 2018
- This deviceK222919 GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −9 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −8 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −7 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −6 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −5 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −4 | K094061 | Kensey Nash Ecm Surgical Patch | Kensey Nash Corporation | 2010 | — |
| −3 | K132025 | Meso Bilayer Surgical Mesh | Kensey Nash Corporation Dba Dsm Biomedical | 2013 | — |
| −2 | K163217 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | 2017 | — |
| −1 | K173333 | GORE ENFORM Biomaterial | W. L. Gore & Associates, Inc. | 2018 | — |
| 0 (this device) | K222919 | GORE® ENFORM Biomaterial | W. L. Gore and Associates, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 10 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K173333 | GORE ENFORM BiomaterialSummary page 4…al Classification Name: Mesh, Surgical, Polymeric Regulation: 21CFR 878.3300 / Surgical Mesh Classification: Class II Product Code: OXF, OWT, OWZ, OXC Predicate Devices K173333 GORE® ENFORM Biomaterial K152309 GORE® SYNECOR Intraperitoneal Biomaterial Device Description As packaged, GORE® ENFORM Biomater… | 2018 |
| * | K152609 | GORE SYNECOR Biomaterial Our reading of the summary gave K152309, FDA’s number for LOGIQ E9, LOGIQ E9 XDClear 2.0 (GE Medical Systems Ultrasound and Primary Care Diagnostics). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “GORE® SYNECOR Intraperitoneal Biomaterial”. | 2015 |
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 30 years and passes through 8 companies; a new generation was cleared every 3.3 years on median.
- 6 of the 82 ancestors have a recall of any class.
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. 2022, 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® ENFORM Biomaterial is indicated 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® ENFORM Biomaterial may be used include hernia repair as suture-line reinforcement, muscle flap reinforcement, and general tissue reconstructions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222919 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222919: GORE® ENFORM Biomaterial.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222919
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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