510(k) · Cleared
Recalled · Class II · 2013Colla-Tec Absorbable Collagen Membrane
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Colla-Tec, Inc. · LYC Bone Grafting Material, Synthetic
Cleared on Aug 22, 1995 after a 1,085-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 60 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 22, 1995
- Review
- 1,085 days
- Class
- Class II
- Product code
- LYC
- Recalls
- 2
- Predicates
- 0
60 later devices descend from it, 1 citing it directly.
- This deviceK924408 Colla-Tec Absorbable Collagen MembraneColla-Tec, Inc. · 1995
- Descendant · cites it directly · 59 of its ownK992216 Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable…Integra Lifesciences Corp. · 1999 · Recalled
- Descendant · 2 generations on · 58 of its ownK042197 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone…Ed. Geistlich Soehne AG Fuer Chemische Industrie · 2004
- Descendant · 3 generations on · 53 of its ownK050446 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneEd. Geistlich Soehne AG Fuer Chemische Industrie · 2005
- Descendant · 3 generations on · 23 of its ownK112572 Geistlich Combi-Kit CollegenGeistlich Pharma AG · 2011
- Descendant · 4 generations on · 21 of its ownK122894 Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit…Geistlich Pharma AG · 2013
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K992216Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen MenbraneIntegra Lifesciences Corp. · 1999 · cites it directly59descendants
- K042197Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone RegenerationEd. Geistlich Soehne AG Fuer Chemische Industrie · 2004 · 2 generations on58descendants
- K050446Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneEd. Geistlich Soehne AG Fuer Chemische Industrie · 2005 · 3 generations on53descendants
- K112572Geistlich Combi-Kit CollegenGeistlich Pharma AG · 2011 · 3 generations on23descendants
- K122894Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich…Geistlich Pharma AG · 2013 · 4 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924408 | Colla-Tec Absorbable Collagen Membrane | Colla-Tec, Inc. | 1995 | — |
| +1 | K992216 | Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen… | Integra Lifesciences Corp. | 1999 | 1 |
| +2 | K042197 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2004 | — |
| +3 | K050446 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2005 | — |
| +3 | K112572 | Geistlich Combi-Kit Collegen | Geistlich Pharma AG | 2011 | — |
| +4 | K122894 | Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen… | Geistlich Pharma AG | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 8 | 0 |
| 2026 | 2 | 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 LYC? 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 LYC device
- #1 K253317 Cytrans™ Elashieldscore 14.3 · 10 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (60)
See all 601 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992216 | Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen Menbrane | 1999 | 59 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 28, 2013 | Class II | Z-1301-2013 | Process control | Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. |
| Mar 28, 2013 | Class II | Z-1298-2013 | Process control | Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K992216 (Integra Lifesciences Corp., 1999) has gone furthest, with 59 descendants of its own.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYC
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYC
2in 2025
MAUDE reports naming product code LYC, 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 | 13 | 80 | 0 | 23 |
| 2008 | 8 | 73 | 0 | 25 |
| 2009 | 14 | 100 | 1 | 25 |
| 2010 | 13 | 164 | 2 | 28 |
| 2011 | 9 | 224 | 0 | 21 |
| 2012 | 5 | 120 | 2 | 10 |
| 2013 | 2 | — | 0 | 12 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 2 | — | 2 | 140 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 1 | 14 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 3 | 156 | 0 | 5 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 2 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 3 | 267 | 0 | 2 |
| 2026 | 3 | 266 | 0 | — |
https://510kreport.com/device/K924408 · printed Nov 6, 2026
Cite this page
510(k) Report. “K924408: Colla-Tec Absorbable Collagen Membrane.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924408
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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