510(k) · Cleared
ClearedCapset Calcium Sulfate Bone Graft Plaster
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifecore Biomedical, Inc. · LYC Bone Grafting Material, Synthetic
Cleared on Jan 23, 1996 after a 77-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
- Jan 23, 1996
- Review
- 77 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK955096 Capset Calcium Sulfate Bone Graft PlasterLifecore Biomedical, Inc. · 1996
- Descendant · cites it directly · 4 of its ownK041324 Calmatrix Calcium Sulfate Bone Graft BinderLifecore Biomedical, Inc. · 2004
- Descendant · 2 generations on · 1 of its ownK060285 Bonegen - TRBio-Lok Intl., Inc. · 2006
- Descendant · cites it directly · 1 of its ownK031073 Perioglas Plus - Settable Bone Graft SubstituteNovabone Products, LLC · 2003
- Descendant · 2 generations on · 0 of its ownK131385 Easy-GraftDegradable Solutions AG · 2013
- Descendant · 2 generations on · 0 of its ownK113049 Socket GraftSteiner Laboratories · 2012
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K041324Calmatrix Calcium Sulfate Bone Graft BinderLifecore Biomedical, Inc. · 2004 · cites it directly4descendants
- K060285Bonegen - TRBio-Lok Intl., Inc. · 2006 · 2 generations on1descendant
- K031073Perioglas Plus - Settable Bone Graft SubstituteNovabone Products, LLC · 2003 · cites it directly1descendant
- K131385Easy-GraftDegradable Solutions AG · 2013 · 2 generations on0descendants
- K113049Socket GraftSteiner Laboratories · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955096 | Capset Calcium Sulfate Bone Graft Plaster | Lifecore Biomedical, Inc. | 1996 | — |
| +1 | K041324 | Calmatrix Calcium Sulfate Bone Graft Binder | Lifecore Biomedical, Inc. | 2004 | — |
| +2 | K060285 | Bonegen - TR | Bio-Lok Intl., Inc. | 2006 | — |
| +1 | K031073 | Perioglas Plus - Settable Bone Graft Substitute | Novabone Products, LLC | 2003 | — |
| +2 | K131385 | Easy-Graft | Degradable Solutions AG | 2013 | — |
| +2 | K113049 | Socket Graft | Steiner Laboratories | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 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, K041324 (Lifecore Biomedical, Inc., 2004) has gone furthest, with 4 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/K955096 · printed Nov 5, 2026
Cite this page
510(k) Report. “K955096: Capset Calcium Sulfate Bone Graft Plaster.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955096
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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