510(k) · Cleared
ClearedGore Resolut Regenerative Material, Gore Resolut XT Regenerative Membrane, Gore Osseoquest Regenerative Membrane
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · NPK Barrier, Synthetic, Intraoral
Cleared on Jun 15, 2005 as substantially equivalent to K960724 (Geistlich-Pharma, 1997) and 2 other predicates after a 30-day review. Its family tree reaches back 2 generations to 1997. 3 later devices descend from it.
- Decided
- Jun 15, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- NPK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K960724 (1997). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK960724 Bio-Gide Resorbable Bilayer MembraneGeistlich-Pharma · 1997
- 1 generation backK011695 Collagen Dental MembraneCollagen Matrix, Inc. · 2001 · Recalled
- This deviceK051267 Gore Resolut Regenerative Material, Gore Resolut XT Regenerative…W. L. Gore & Associates, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK091120 Medpor Contain ImplantPorex Surgical, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK132325 Guidor Bioresorbable Matrix BarrierSunstar Americas, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK102184 Medpor Contain Can ImplantPorex Surgical, Inc. · 2011
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960724 | Bio-Gide Resorbable Bilayer Membrane | Geistlich-Pharma | 1997 | — |
| −1 | K011695 | Collagen Dental Membrane | Collagen Matrix, Inc. | 2001 | 1 |
| 0 (this device) | K051267 | Gore Resolut Regenerative Material, Gore Resolut XT Regenerative Membrane… | W. L. Gore & Associates, Inc. | 2005 | — |
| +1 | K091120 | Medpor Contain Implant | Porex Surgical, Inc. | 2010 | — |
| +1 | K132325 | Guidor Bioresorbable Matrix Barrier | Sunstar Americas, Inc. | 2013 | — |
| +2 | K102184 | Medpor Contain Can Implant | Porex Surgical, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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 NPK? 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 NPK device
- #1 K221851 Lumina-PTFE Titaniumscore 7.4 · 4 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 |
|---|---|---|---|
| * | K960724 | Bio-Gide Resorbable Bilayer MembraneSummary page 1…LUT® ADAPT Regenerative Membrane, and GORE RESOLUJT'~ ADAPT LT Regenerative Membrane 3. Predicate Devices: BIO-GIDE®' Resorbable Bilayer Membrane (K960724), BIOBAR Biodegradable Collagen Membrane (K001598), and Collagen Dental Membrane (K01 1695). 4. Device Des… | 1997 |
| * | K001598 | Biobar, Implantable Biodegradable Collagen Membrane for Guided Bone RegenerationSummary page 1…T'~ ADAPT LT Regenerative Membrane 3. Predicate Devices: BIO-GIDE®' Resorbable Bilayer Membrane (K960724), BIOBAR Biodegradable Collagen Membrane (K001598), and Collagen Dental Membrane (K01 1695). 4. Device Description: These devices are composed of synthetic… | 2000 |
| * | K011695 | Collagen Dental MembraneSummary page 1…icate Devices: BIO-GIDE®' Resorbable Bilayer Membrane (K960724), BIOBAR Biodegradable Collagen Membrane (K001598), and Collagen Dental Membrane (K01 1695). 4. Device Description: These devices are composed of synthetic resorbable copolymers and have been desi… | 2001 |
What descends from it? (3)
2 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 8 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K091120 (Porex Surgical, Inc., 2010) has gone furthest, with 1 descendant of its own.
- 10 other devices also cite its predicate K960724.
How does its category compare?
All NPK devicesNPK Barrier, Synthetic, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NPK
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NPK
529in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NPK
No recall names NPK since 2007.
Adverse event reports per year · NPK
3in 2022
MAUDE reports naming product code NPK, 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 | 1 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 2 | — | 0 | 13 |
| 2011 | 1 | — | 0 | 35 |
| 2012 | 0 | — | 0 | 17 |
| 2013 | 1 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 3 | 529 | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
it is intended for use during the process of guided bone regeneration as a bioabsorbable membrane for supporting: augmentation around immediately placed endosseous implants or existing endosseous implants (e.g., dehiscence and fenestration defects, extraction sockets); ridge augmentation for later implantation of endosseous implants; and sinus procedures (e.g., sinus window, sinus lift).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K051267 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051267: Gore Resolut Regenerative Material, Gore Resolut XT Regenerative Membrane, Gore Osseoquest Regenerative Membrane.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051267
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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