510(k) · Cleared
ClearedFortagen Oral Membrane
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Organogenesis, Inc. · NPL Barrier, Animal Source, Intraoral
Cleared on Aug 30, 2007 as substantially equivalent to K021105 (Organogenesis, Inc., 2002) and 2 other predicates after an 84-day review. Its family tree reaches back 4 generations to 1992. 1 later device descends from it.
- Decided
- Aug 30, 2007
- Review
- 84 days
- Class
- Class II
- Product code
- NPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K921895 (1992). 13 ancestors in all, the oldest K830889 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 3 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 2 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 1 generation backK021105 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- This deviceK071555 Fortagen Oral MembraneOrganogenesis, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK102307 Genoss Collagen Membrane Model GCM1020, GCM3040 Total 6 ModelsGenoss Co., Ltd. · 2011
Most influential descendants
Showing 1 of 1 · See all- K102307Genoss Collagen Membrane Model GCM1020, GCM3040 Total 6 ModelsGenoss Co., Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −3 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −2 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −1 | K021105 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| 0 (this device) | K071555 | Fortagen Oral Membrane | Organogenesis, Inc. | 2007 | — |
| +1 | K102307 | Genoss Collagen Membrane Model GCM1020, GCM3040 Total 6 Models | Genoss Co., Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 NPL? 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 NPL device
- #1 K212463 Geistlich Bio-Gide, Geistlich Bio-Gide Shape…score 14.5 · 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 |
|---|---|---|---|
| * | K021105 | Fortaflex Surgical MeshSummary page 1…-based surgical mesh devices and collagen dental membranes previously cleared for commercial distribution. The relevant predicate devices include FortaGen Surgical Mesh (K021105), formerly FortaFlex Surgical Mesh, manufactured by Organogenesis Inc., Ossix-Plus (K053260) manufactured by Colbar LifeScience,… | 2002 |
| * | K053260 | Ossix -PlusSummary page 1…distribution. The relevant predicate devices include FortaGen Surgical Mesh (K021105), formerly FortaFlex Surgical Mesh, manufactured by Organogenesis Inc., Ossix-Plus (K053260) manufactured by Colbar LifeScience, Ltd., and Bio-Gide Resorbable Bilayer Membrane (K050446) manufactured by Ed. Geistlich Soehn… | 2006 |
| * | K050446 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneSummary page 1…rly FortaFlex Surgical Mesh, manufactured by Organogenesis Inc., Ossix-Plus (K053260) manufactured by Colbar LifeScience, Ltd., and Bio-Gide Resorbable Bilayer Membrane (K050446) manufactured by Ed. Geistlich Soehne Ag fuir Chemische Industrie. Intended Use: FortaGen Oral Membrane is intended to be used d… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102307 | Genoss Collagen Membrane Model GCM1020, GCM3040 Total 6 Models | 2011 | 0 |
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 15 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K102307 (Genoss Co., Ltd., 2011) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K021105.
How does its category compare?
All NPL devicesNPL Barrier, Animal Source, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NPL
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NPL
132in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NPL
6in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NPL
39in 2025
MAUDE reports naming product code NPL, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 172 | 0 | 0 |
| 2009 | 3 | 193 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 4 | 286 | 0 | 0 |
| 2012 | 0 | — | 3 | 3 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 5 | 140 | 0 | 3 |
| 2015 | 1 | — | 0 | 5 |
| 2016 | 3 | 184 | 0 | 9 |
| 2017 | 3 | 200 | 0 | 18 |
| 2018 | 1 | — | 0 | 14 |
| 2019 | 1 | — | 6 | 22 |
| 2020 | 2 | — | 0 | 8 |
| 2021 | 2 | — | 0 | 11 |
| 2022 | 3 | 290 | 0 | 19 |
| 2023 | 2 | — | 0 | 5 |
| 2024 | 3 | 263 | 0 | 20 |
| 2025 | 5 | 132 | 0 | 39 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
FortaGen Oral Membrane is intended to be used during guided bone and guided tissue regeneration procedures as a biodegradable barrier membrane for: • Ridge augmentation for later implant insertions; • Simultaneous ridge augmentation and implant insertions; • Ridge augmentation around implants inserted in delayed extraction sites; • Ridge augmentation around implants inserted in immediate extraction sites; • Alveolar ridge preservation consequent to tooth…
Read the full statement (123 words)
FortaGen Oral Membrane is intended to be used during guided bone and guided tissue regeneration procedures as a biodegradable barrier membrane for:
• Ridge augmentation for later implant insertions;
• Simultaneous ridge augmentation and implant insertions;
• Ridge augmentation around implants inserted in delayed extraction sites;
• Ridge augmentation around implants inserted in immediate extraction sites;
• Alveolar ridge preservation consequent to tooth (teeth) extraction(s);
• Over the window in lateral window sinus elevation procedures;
• In implants with vertical bone loss due to infection, only in cases where satisfactory debridement and implant surface disinfection can be achieved;
• In intra bony defects around teeth;
• For treatment of recession defects, together with coronally positioned flap;
• In furcation defects in multi-rooted teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071555 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071555: Fortagen Oral Membrane.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071555
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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