510(k) · Cleared
Recalled · 2006Atrisorb Bioabsorbable Guided Tissue Regeneration (GTR) Barrier Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atrix Laboratories, Inc. · NPK Barrier, Synthetic, Intraoral
Cleared on Sep 8, 1998 after a 26-day review. The FDA summary names its predicate without a number. 6 later devices descend from it. It has been recalled once.
- Decided
- Sep 8, 1998
- Review
- 26 days
- Class
- Class II
- Product code
- NPK
- Recalls
- 1
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK982865 Atrisorb Bioabsorbable Guided Tissue Regeneration (GTR) Barrier KitAtrix Laboratories, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK082111 Straumann MembragelInstitut Straumann AG · 2009
- Descendant · cites it directly · 1 of its ownK060285 Bonegen - TRBio-Lok Intl., Inc. · 2006
- Descendant · cites it directly · 0 of its ownK131385 Easy-GraftDegradable Solutions AG · 2013
- Descendant · 2 generations on · 0 of its ownK102208 NanogenOrthogen, LLC · 2011
- Descendant · 2 generations on · 0 of its ownK101956 Straumann MembragelStraumann USA (On Behalf of Institut Straumann Ag) · 2010
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K082111Straumann MembragelInstitut Straumann AG · 2009 · cites it directly1descendant
- K060285Bonegen - TRBio-Lok Intl., Inc. · 2006 · cites it directly1descendant
- K131385Easy-GraftDegradable Solutions AG · 2013 · cites it directly0descendants
- K102208NanogenOrthogen, LLC · 2011 · 2 generations on0descendants
- K101956Straumann MembragelStraumann USA (On Behalf of Institut Straumann Ag) · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982865 | Atrisorb Bioabsorbable Guided Tissue Regeneration (GTR) Barrier Kit | Atrix Laboratories, Inc. | 1998 | — |
| +1 | K082111 | Straumann Membragel | Institut Straumann AG | 2009 | — |
| +1 | K060285 | Bonegen - TR | Bio-Lok Intl., Inc. | 2006 | — |
| +1 | K131385 | Easy-Graft | Degradable Solutions AG | 2013 | — |
| +2 | K102208 | Nanogen | Orthogen, LLC | 2011 | — |
| +2 | K101956 | Straumann Membragel | Straumann USA (On Behalf of Institut Straumann Ag) | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | GORE-TEX® Periodontal Material Named without a submission number |
What descends from it? (6)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 26, 2006 | Not classified | Z-0476-06 | Other | Injectable needles were included in procedure kits instead of sterile blunt cannulas. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K082111 (Institut Straumann AG, 2009) has gone furthest, with 1 descendant of its own.
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?
ATRISORB® GTR Barrier is indicated for the surgical treatment of periodonital defects to aid in the regeneration and integration of tissue components in guided tissue rageneration procedures.
ATRISORB® GTR Barrier is not intended for use in defects outside the indications statement.
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/K982865 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982865: Atrisorb Bioabsorbable Guided Tissue Regeneration (GTR) Barrier Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982865
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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