510(k) · Cleared
ClearedFoundation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Corp. · LYC Bone Grafting Material, Synthetic
Cleared on Oct 13, 2004 as substantially equivalent to K974399 (Geistlich-Pharma, 1998) after a 201-day review. Its family tree reaches back 1 generation to 1998. 3 later devices descend from it.
- Decided
- Oct 13, 2004
- Review
- 201 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974399 (1998). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK974399 Bio-Oss CollagenGeistlich-Pharma · 1998
- This deviceK040783 FoundationTerumo Corp. · 2004
- Descendant · cites it directly · 0 of its ownK150079 Regenomer® Syringe, Regenomer® Plug, Regenomer® BlockNibec Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK111087 FoundationOlympus Terumo Biomaterials Corporation · 2011
- Descendant · cites it directly · 0 of its ownK083742 Synoss Collagen Synthetic Mineral-Collagen Bone Graft MatrixCollagen Matrix, Inc. · 2009
Most influential descendants
Showing 3 of 3 · See all- K150079Regenomer® Syringe, Regenomer® Plug, Regenomer® BlockNibec Co., Ltd. · 2015 · cites it directly0descendants
- K111087FoundationOlympus Terumo Biomaterials Corporation · 2011 · cites it directly0descendants
- K083742Synoss Collagen Synthetic Mineral-Collagen Bone Graft MatrixCollagen Matrix, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974399 | Bio-Oss Collagen | Geistlich-Pharma | 1998 | — |
| 0 (this device) | K040783 | Foundation | Terumo Corp. | 2004 | — |
| +1 | K150079 | Regenomer® Syringe, Regenomer® Plug, Regenomer® Block | Nibec Co., Ltd. | 2015 | — |
| +1 | K111087 | Foundation | Olympus Terumo Biomaterials Corporation | 2011 | — |
| +1 | K083742 | Synoss Collagen Synthetic Mineral-Collagen Bone Graft Matrix | Collagen Matrix, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K974399 | Bio-Oss CollagenSummary page 5…of the FDA's medical device regulations to BIO-OSS COLLAGEN, which is approved for the filling of extraction sockets to enhance the preservation of the alveolar ridge (K#974399). The FOUNDATION device has the same general intended use, similar principles of operation, and similar technological characteris… | 1998 |
What descends from it? (3)
3 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?
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 | — |
What is it indicated for?
The FOUNDATION device is a collagen-based bone filling augmentation
material for use in the filling of extraction sockets.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K040783 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040783: Foundation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040783
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026