510(k) · Cleared
ClearedBSM Bone Substitute Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Nov 13, 2001 after a 221-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 48 later devices descend from it.
- Decided
- Nov 13, 2001
- Review
- 221 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 0
48 later devices descend from it, 7 citing it directly.
- This deviceK011048 BSM Bone Substitute MaterialDePuy Orthopaedics, Inc. · 2001
- Descendant · cites it directly · 39 of its ownK033138 CAP3 Bone Substitute MaterialEtex Corp. · 2003
- Descendant · 2 generations on · 34 of its ownK063050 Cap PlusEtex Corp. · 2007
- Descendant · 2 generations on · 29 of its ownK080329 Cap Plus, Equivabone, Cap/DBMEtex Corp. · 2008
- Descendant · 3 generations on · 28 of its ownK090310 EquivaboneEtex Corp. · 2009
- Descendant · cites it directly · 26 of its ownK072636 A-BSM Bone Substitute MaterialEtex Corp. · 2007
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K033138CAP3 Bone Substitute MaterialEtex Corp. · 2003 · cites it directly39descendants
- K063050Cap PlusEtex Corp. · 2007 · 2 generations on34descendants
- K080329Cap Plus, Equivabone, Cap/DBMEtex Corp. · 2008 · 2 generations on29descendants
- K090310EquivaboneEtex Corp. · 2009 · 3 generations on28descendants
- K072636A-BSM Bone Substitute MaterialEtex Corp. · 2007 · cites it directly26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011048 | BSM Bone Substitute Material | DePuy Orthopaedics, Inc. | 2001 | — |
| +1 | K033138 | CAP3 Bone Substitute Material | Etex Corp. | 2003 | — |
| +2 | K063050 | Cap Plus | Etex Corp. | 2007 | — |
| +2 | K080329 | Cap Plus, Equivabone, Cap/DBM | Etex Corp. | 2008 | — |
| +3 | K090310 | Equivabone | Etex Corp. | 2009 | — |
| +1 | K072636 | A-BSM Bone Substitute Material | Etex Corp. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 1 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 MQV? 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 MQV device
- #1 K232315 Catalyst Bone Void Fillerscore 25.2 · 25 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? (48)
See all 487 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033138 | CAP3 Bone Substitute Material | 2003 | 39 |
| K072636 | A-BSM Bone Substitute Material | 2007 | 26 |
| K062630 | Ossipro Bone Substitute Material | 2007 | 26 |
| K030178 | Calcigen Psi Bone Graft Substitute | 2003 | 3 |
| K041089 | Oss Bone Graft System and Oss Rapidset Bone Graft System | 2004 | 0 |
| K041493 | Cementek | 2004 | 0 |
| K033611 | Calcigen -Nap Bone Void Filler | 2004 | 0 |
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, K033138 (Etex Corp., 2003) has gone furthest, with 39 descendants of its own.
How does its category compare?
All MQV devicesMQV Filler, Bone Void, Calcium Compound: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQV
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQV
57in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQV
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQV
57in 2025
MAUDE reports naming product code MQV, 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 | 35 | 144 | 5 | 67 |
| 2008 | 32 | 102 | 3 | 71 |
| 2009 | 23 | 180 | 1 | 81 |
| 2010 | 17 | 147 | 0 | 68 |
| 2011 | 16 | 92 | 6 | 114 |
| 2012 | 9 | 107 | 3 | 149 |
| 2013 | 12 | 197 | 2 | 223 |
| 2014 | 20 | 153 | 0 | 111 |
| 2015 | 18 | 184 | 0 | 125 |
| 2016 | 8 | 214 | 1 | 106 |
| 2017 | 17 | 124 | 1 | 107 |
| 2018 | 23 | 124 | 2 | 86 |
| 2019 | 13 | 90 | 0 | 65 |
| 2020 | 15 | 132 | 1 | 126 |
| 2021 | 8 | 88 | 0 | 101 |
| 2022 | 9 | 118 | 0 | 47 |
| 2023 | 21 | 74 | 3 | 120 |
| 2024 | 28 | 55 | 2 | 68 |
| 2025 | 14 | 57 | 1 | 57 |
| 2026 | 5 | 96 | 4 | — |
https://510kreport.com/device/K011048 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011048: BSM Bone Substitute Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011048
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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