510(k) · Cleared
Recalled · Class II · 2017Inion GTR Biodegradable Membrane System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inion, Ltd. · NPK Barrier, Synthetic, Intraoral
Cleared on Mar 31, 2004 as substantially equivalent to K955838 (Atrix Laboratories, Inc., 1996) and 2 other predicates after a 184-day review. Its family tree reaches back 1 generation to 1996. 8 later devices descend from it. It has been recalled once.
- Decided
- Mar 31, 2004
- Review
- 184 days
- Class
- Class II
- Product code
- NPK
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K955838 (1996). 3 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK955838 Atrisorb Bioabsorbable Guided Tissue Regneration (GTR)Atrix Laboratories, Inc. · 1996
- This deviceK033074 Inion GTR Biodegradable Membrane SystemInion, Ltd. · 2004
- Descendant · cites it directly · 5 of its ownK080308 Bio-Scaffold Bioscaff Alvelac Resobable ScaffoldBioscaffold International Pte, Ltd. · 2008
- Descendant · 2 generations on · 2 of its ownK082419 Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc. · 2009
- Descendant · 3 generations on · 1 of its ownK101827 OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011
- Descendant · 2 generations on · 1 of its ownK090083 Cytoflex Resorb, Model C03-0010 Through C03-090Unicare Biomedical, Inc. · 2009
- Descendant · 3 generations on · 0 of its ownK253317 Cytrans™ ElashieldGC America, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K080308Bio-Scaffold Bioscaff Alvelac Resobable ScaffoldBioscaffold International Pte, Ltd. · 2008 · cites it directly5descendants
- K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc. · 2009 · 2 generations on2descendants
- K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011 · 3 generations on1descendant
- K090083Cytoflex Resorb, Model C03-0010 Through C03-090Unicare Biomedical, Inc. · 2009 · 2 generations on1descendant
- K253317Cytrans™ ElashieldGC America, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955838 | Atrisorb Bioabsorbable Guided Tissue Regneration (GTR) | Atrix Laboratories, Inc. | 1996 | — |
| 0 (this device) | K033074 | Inion GTR Biodegradable Membrane System | Inion, Ltd. | 2004 | — |
| +1 | K080308 | Bio-Scaffold Bioscaff Alvelac Resobable Scaffold | Bioscaffold International Pte, Ltd. | 2008 | — |
| +2 | K082419 | Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1 | Intra-Lock International, Inc. | 2009 | — |
| +3 | K101827 | Osteoscaf | Texas Innovative Medical Devices (Dba) Skeletal | 2011 | — |
| +2 | K090083 | Cytoflex Resorb, Model C03-0010 Through C03-090 | Unicare Biomedical, Inc. | 2009 | — |
| +3 | K253317 | Cytrans™ Elashield | GC America, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K955838 | Atrisorb Bioabsorbable Guided Tissue Regneration (GTR)Summary page 2…Status: Final PREDICATE DEVICES (1) Atrix Laboratories, Inc.; Atrisorb®Bioabsorbable Guided Tissue Regeneration (GTR) Barrier (K955838) (2) W.L. Gore & Associates, Inc.; Gore ResolutTM XT Regenerative Material (973594) and Gore OsseoQuest Regenerative… | 1996 |
| * | K973594 | Gore Resolut XT Regenerative MaterialSummary page 2…(GTR) Barrier (K955838) (2) W.L. Gore & Associates, Inc.; Gore ResolutTM XT Regenerative Material (973594) and Gore OsseoQuest Regenerative Membrane (K973594) (3) Geistlich- Pharma; Resor Pin Resorbable Membrane Pin (K972817) INTENDED) USE 1.1 Indications for Use The Inion GTR… | 1997 |
| * | K972817 | Resor-Pin Resorbable Membrane PinSummary page 2…ore ResolutTM XT Regenerative Material (973594) and Gore OsseoQuest Regenerative Membrane (K973594) (3) Geistlich- Pharma; Resor Pin Resorbable Membrane Pin (K972817) INTENDED) USE 1.1 Indications for Use The Inion GTRT M Biodegradable Membrane System is indicated for the surgical treatme… | 1998 |
What descends from it? (8)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 1, 2017 | Class II | Z-1478-2017 | Other | Aluminum pouch seal was noticed to be defective (slightly open). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
The Inion GTR TM Biodegradable Membrane System is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures (e.g. class II furcation defects, intrabony defects and recession type defects), for pre-implant and peri-implant surgery and for covering bone defects and empty sockets.
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/K033074 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033074: Inion GTR Biodegradable Membrane System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033074
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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