510(k) · Cleared
ClearedMedtronic Sofamor Danek Biphasic Calcium Phosphate (BCP) Bone Void Filler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · LYC Bone Grafting Material, Synthetic
Cleared on Jun 5, 2001 after an 89-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
- Jun 5, 2001
- Review
- 89 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK010701 Medtronic Sofamor Danek Biphasic Calcium Phosphate (BCP) Bone Void…Medtronic Sofamor Danek USA, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK040646 Straumann GranulesThe Straumann Co. · 2004
- Descendant · cites it directly · 1 of its ownK081784 Mastergraft PuttyMedtronic Sofamor Danek · 2008
- Descendant · 2 generations on · 0 of its ownK201051 Straumann BoneCeramicInstitut Straumann AG · 2020
- Descendant · 2 generations on · 0 of its ownK140374 Mastergraft PuttyMedtronic Sofamor Danek USA, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK050170 Fortoss Vital Bone Graft SubstituteBiocomposites, Ltd. · 2005
Most influential descendants
Showing 5 of 5 · See all- K040646Straumann GranulesThe Straumann Co. · 2004 · cites it directly2descendants
- K081784Mastergraft PuttyMedtronic Sofamor Danek · 2008 · cites it directly1descendant
- K201051Straumann BoneCeramicInstitut Straumann AG · 2020 · 2 generations on0descendants
- K140374Mastergraft PuttyMedtronic Sofamor Danek USA, Inc. · 2014 · 2 generations on0descendants
- K050170Fortoss Vital Bone Graft SubstituteBiocomposites, Ltd. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010701 | Medtronic Sofamor Danek Biphasic Calcium Phosphate (BCP) Bone Void Filler | Medtronic Sofamor Danek USA, Inc. | 2001 | — |
| +1 | K040646 | Straumann Granules | The Straumann Co. | 2004 | — |
| +1 | K081784 | Mastergraft Putty | Medtronic Sofamor Danek | 2008 | — |
| +2 | K201051 | Straumann BoneCeramic | Institut Straumann AG | 2020 | — |
| +2 | K140374 | Mastergraft Putty | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| +2 | K050170 | Fortoss Vital Bone Graft Substitute | Biocomposites, Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 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 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, K040646 (The Straumann Co., 2004) has gone furthest, with 2 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/K010701 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010701: Medtronic Sofamor Danek Biphasic Calcium Phosphate (BCP) Bone Void Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010701
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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