510(k) · Cleared
ClearedOssix -Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Colbar Lifescience, Ltd. · NPL Barrier, Animal Source, Intraoral
Cleared on Feb 22, 2006 after a 92-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.
- Decided
- Feb 22, 2006
- Review
- 92 days
- Class
- Class II
- Product code
- NPL
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 9 citing it directly.
- This deviceK053260 Ossix -PlusColbar Lifescience, Ltd. · 2006
- Descendant · cites it directly · 4 of its ownK101453 Vitala Natural Resorbable Collagen MembraneObi Biologics, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK141177 Vitala Porcine Derived Collagen MembraneOsteogenics Biomedical, Inc. (Formerly Obi Biologi · 2015
- Descendant · 3 generations on · 2 of its ownK173562 Straumann Jason MembraneInstitut Straumann AG · 2018
- Descendant · cites it directly · 1 of its ownK160281 Ossix PlusDatum Dental, Ltd. · 2016
- Descendant · cites it directly · 1 of its ownK071555 Fortagen Oral MembraneOrganogenesis, Inc. · 2007
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K101453Vitala Natural Resorbable Collagen MembraneObi Biologics, Inc. · 2011 · cites it directly4descendants
- K141177Vitala Porcine Derived Collagen MembraneOsteogenics Biomedical, Inc. (Formerly Obi Biologi · 2015 · 2 generations on3descendants
- K173562Straumann Jason MembraneInstitut Straumann AG · 2018 · 3 generations on2descendants
- K160281Ossix PlusDatum Dental, Ltd. · 2016 · cites it directly1descendant
- K071555Fortagen Oral MembraneOrganogenesis, Inc. · 2007 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053260 | Ossix -Plus | Colbar Lifescience, Ltd. | 2006 | — |
| +1 | K101453 | Vitala Natural Resorbable Collagen Membrane | Obi Biologics, Inc. | 2011 | — |
| +2 | K141177 | Vitala Porcine Derived Collagen Membrane | Osteogenics Biomedical, Inc. (Formerly Obi Biologi | 2015 | — |
| +3 | K173562 | Straumann Jason Membrane | Institut Straumann AG | 2018 | — |
| +1 | K160281 | Ossix Plus | Datum Dental, Ltd. | 2016 | — |
| +1 | K071555 | Fortagen Oral Membrane | Organogenesis, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | — | Bio-Bar Named without a submission number | |
| * | — | Bio-Gide Resorbable Bilayer Membrane Named without a submission number | |
| * | — | OSSIX Named without a submission number |
What descends from it? (14)
See all 149 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101453 | Vitala Natural Resorbable Collagen Membrane | 2011 | 4 |
| K160281 | Ossix Plus | 2016 | 1 |
| K071555 | Fortagen Oral Membrane | 2007 | 1 |
| K153549 | Ossix Volumax | 2016 | 0 |
| K123697 | Matricel Dental Barrier Membrane | 2014 | 0 |
| K132325 | Guidor Bioresorbable Matrix Barrier | 2013 | 0 |
| K103087 | Covamax Resorbable Collagen Membrane | 2011 | 0 |
| K110600 | Collagen Dental Mambrane - Porcine Type I Collagen | 2011 | 0 |
| 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?
- Of its descendants, K101453 (Obi Biologics, Inc., 2011) has gone furthest, with 4 descendants of its own.
How does its category compare?
All NPL devicesNPL Barrier, Animal Source, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
OssixTM-PLUS biodegradable collagen membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier 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…
Read the full statement (118 words)
OssixTM-PLUS biodegradable collagen membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier 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 debridment 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K053260 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053260: Ossix -Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053260
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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