510(k) · Cleared
Recalled · Class II · 2019Collagen Periodontal Membrane
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Collagen Matrix, Inc. · NPL Barrier, Animal Source, Intraoral
Cleared on Jan 8, 2001 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 87 later devices descend from it. It has been recalled once.
- Decided
- Jan 8, 2001
- Review
- 75 days
- Class
- Class II
- Product code
- NPL
- Recalls
- 1
- Predicates
- 0
87 later devices descend from it, 3 citing it directly.
- This deviceK003339 Collagen Periodontal MembraneCollagen Matrix, Inc. · 2001
- Descendant · cites it directly · 84 of its ownK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
- Descendant · 2 generations on · 67 of its ownK043308 Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005
- Descendant · 2 generations on · 59 of its ownK051386 Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005
- Descendant · 2 generations on · 54 of its ownK033679 Copsios Bone Void Filler (BVF)Centerpulse Spine-Tech, Inc. · 2004
- Descendant · 2 generations on · 47 of its ownK071813 Mastergraft PuttyMedtronic Sofamor Danek · 2007
Showing 5 of 87 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 87 · See all- K012751Healos Bone Graft MaterialOrquest, Inc. · 2001 · cites it directly84descendants
- K043308Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005 · 2 generations on67descendants
- K051386Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005 · 2 generations on59descendants
- K033679Copsios Bone Void Filler (BVF)Centerpulse Spine-Tech, Inc. · 2004 · 2 generations on54descendants
- K071813Mastergraft PuttyMedtronic Sofamor Danek · 2007 · 2 generations on47descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003339 | Collagen Periodontal Membrane | Collagen Matrix, Inc. | 2001 | — |
| +1 | K012751 | Healos Bone Graft Material | Orquest, Inc. | 2001 | — |
| +2 | K043308 | Modification to: Healos Bone Graft Material | Depuy Spine, Inc. | 2005 | — |
| +2 | K051386 | Mastergraft Putty Bone Void Filler | Medtronic Vascular | 2005 | — |
| +2 | K033679 | Copsios Bone Void Filler (BVF) | Centerpulse Spine-Tech, Inc. | 2004 | — |
| +2 | K071813 | Mastergraft Putty | Medtronic Sofamor Danek | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 1 | 0 |
| 2022 | 6 | 0 |
| 2023 | 9 | 0 |
| 2024 | 9 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (87)
See all 873 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 19, 2019 | Class II | Z-1389-2019 | Under Investigation by firm | Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012751 (Orquest, Inc., 2001) has gone furthest, with 84 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 | — |
https://510kreport.com/device/K003339 · printed Nov 5, 2026
Cite this page
510(k) Report. “K003339: Collagen Periodontal Membrane.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003339
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026