510(k) · Cleared
ClearedCerasorb M Ortho
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Curasan AG · MQV Filler, Bone Void, Calcium Compound
Cleared on Mar 26, 2004 after a 56-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Mar 26, 2004
- Review
- 56 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK040216 Cerasorb M OrthoCurasan AG · 2004
- Descendant · cites it directly · 1 of its ownK050416 Ossaplast OrthoOssacur AG · 2005
- Descendant · cites it directly · 0 of its ownK120354 Beta-TCP GranulesSkeletal Kinetics, LLC · 2013
- Descendant · cites it directly · 0 of its ownK100841 BoneoptimizerCurasan AG · 2010
- Descendant · 2 generations on · 0 of its ownK051047 Colloss E Bone Void FillerOssacur AG · 2006
Most influential descendants
Showing 4 of 4 · See all- K050416Ossaplast OrthoOssacur AG · 2005 · cites it directly1descendant
- K120354Beta-TCP GranulesSkeletal Kinetics, LLC · 2013 · cites it directly0descendants
- K100841BoneoptimizerCurasan AG · 2010 · cites it directly0descendants
- K051047Colloss E Bone Void FillerOssacur AG · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040216 | Cerasorb M Ortho | Curasan AG | 2004 | — |
| +1 | K050416 | Ossaplast Ortho | Ossacur AG | 2005 | — |
| +1 | K120354 | Beta-TCP Granules | Skeletal Kinetics, LLC | 2013 | — |
| +1 | K100841 | Boneoptimizer | Curasan AG | 2010 | — |
| +2 | K051047 | Colloss E Bone Void Filler | Ossacur AG | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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 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? (3)
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 |
|---|---|---|---|
| * | — | Cerasorb ORTHO (granular form) Named without a submission number | |
| * | — | Cerasorb ORTHO (block forms) Named without a submission number | |
| * | — | Vitoss Scaffold Synthetic Named without a submission number |
What descends from it? (4)
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?
- Of its descendants, K050416 (Ossacur AG, 2005) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
Cerasorb® M ORTHO (polygonal broken morsels) is intended for use as a bone void filler in voids or gaps (resulting from surgery, trauma or degenerative processes) in the skeletal system (e.g. extremities, spine, pelvis) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the B-TCP ceramic material is gradually resorbed and replaced with bone. The placement of Cerasorb ® M ORTHO should not be in dry form, the material should be mixed with autologous blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040216 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040216: Cerasorb M Ortho.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040216
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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