510(k) · Cleared
Cleared3I Calcium Sodium Phosphate Bone Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · LYC Bone Grafting Material, Synthetic
Cleared on Feb 9, 2001 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Feb 9, 2001
- Review
- 88 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK003493 3I Calcium Sodium Phosphate Bone CementBiomet, Inc. · 2001
- Descendant · cites it directly · 3 of its ownK040501 DBX Demineralized Bone Matrix Putty, Paste and MixMusculoskeletal Transplant Foundation · 2005
- Descendant · 2 generations on · 2 of its ownK080462 Progenix DBM PuttyMedtronic Sofamor Danek · 2008
- Descendant · 3 generations on · 1 of its ownK081950 Progenix PlusMedtronic Sofamor Danek, Inc. · 2008
- Descendant · 3 generations on · 0 of its ownK082463 ProgenixMedtronic Sofamor Danek · 2008
- Descendant · cites it directly · 0 of its ownK033611 Calcigen -Nap Bone Void FillerBiomet, Inc. · 2004
Most influential descendants
Showing 5 of 5 · See all- K040501DBX Demineralized Bone Matrix Putty, Paste and MixMusculoskeletal Transplant Foundation · 2005 · cites it directly3descendants
- K080462Progenix DBM PuttyMedtronic Sofamor Danek · 2008 · 2 generations on2descendants
- K081950Progenix PlusMedtronic Sofamor Danek, Inc. · 2008 · 3 generations on1descendant
- K082463ProgenixMedtronic Sofamor Danek · 2008 · 3 generations on0descendants
- K033611Calcigen -Nap Bone Void FillerBiomet, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003493 | 3I Calcium Sodium Phosphate Bone Cement | Biomet, Inc. | 2001 | — |
| +1 | K040501 | DBX Demineralized Bone Matrix Putty, Paste and Mix | Musculoskeletal Transplant Foundation | 2005 | — |
| +2 | K080462 | Progenix DBM Putty | Medtronic Sofamor Danek | 2008 | — |
| +3 | K081950 | Progenix Plus | Medtronic Sofamor Danek, Inc. | 2008 | — |
| +3 | K082463 | Progenix | Medtronic Sofamor Danek | 2008 | — |
| +1 | K033611 | Calcigen -Nap Bone Void Filler | Biomet, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
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, K040501 (Musculoskeletal Transplant Foundation, 2005) has gone furthest, with 3 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/K003493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003493: 3I Calcium Sodium Phosphate Bone Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003493
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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