510(k) · Cleared
ClearedTBM Sponge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocoll Laboratories, Inc. · LYC Bone Grafting Material, Synthetic
Cleared on Nov 5, 1996 after a 292-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- Nov 5, 1996
- Review
- 292 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK960267 TBM SpongeBiocoll Laboratories, Inc. · 1996
- Descendant · cites it directly · 5 of its ownK043573 Dynagraft II DentalIsotis Orthobiologics, Inc. · 2005
- Descendant · 2 generations on · 3 of its ownK060306 Accell Connexus Demineralized Bone Matrix PuttyIsotis NV · 2006
- Descendant · 3 generations on · 2 of its ownK080462 Progenix DBM PuttyMedtronic Sofamor Danek · 2008
- Descendant · 4 generations on · 1 of its ownK081950 Progenix PlusMedtronic Sofamor Danek, Inc. · 2008
- Descendant · 4 generations on · 0 of its ownK082463 ProgenixMedtronic Sofamor Danek · 2008
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K043573Dynagraft II DentalIsotis Orthobiologics, Inc. · 2005 · cites it directly5descendants
- K060306Accell Connexus Demineralized Bone Matrix PuttyIsotis NV · 2006 · 2 generations on3descendants
- K080462Progenix DBM PuttyMedtronic Sofamor Danek · 2008 · 3 generations on2descendants
- K081950Progenix PlusMedtronic Sofamor Danek, Inc. · 2008 · 4 generations on1descendant
- K082463ProgenixMedtronic Sofamor Danek · 2008 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960267 | TBM Sponge | Biocoll Laboratories, Inc. | 1996 | — |
| +1 | K043573 | Dynagraft II Dental | Isotis Orthobiologics, Inc. | 2005 | — |
| +2 | K060306 | Accell Connexus Demineralized Bone Matrix Putty | Isotis NV | 2006 | — |
| +3 | K080462 | Progenix DBM Putty | Medtronic Sofamor Danek | 2008 | — |
| +4 | K081950 | Progenix Plus | Medtronic Sofamor Danek, Inc. | 2008 | — |
| +4 | K082463 | Progenix | Medtronic Sofamor Danek | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 3 | 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? (7)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K043573 (Isotis Orthobiologics, Inc., 2005) has gone furthest, with 5 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/K960267 · printed Nov 5, 2026
Cite this page
510(k) Report. “K960267: TBM Sponge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960267
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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