510(k) · Cleared
ClearedCerasorb 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 18, 2002 after an 89-day review. The FDA summary names its predicate without a number. 16 later devices descend from it.
- Decided
- Mar 18, 2002
- Review
- 89 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 8 citing it directly.
- This deviceK014156 Cerasorb OrthoCurasan AG · 2002
- Descendant · cites it directly · 4 of its ownK050260 Bioresorb Macro PoreOraltronics Dental Implant Technology GmbH · 2005
- Descendant · cites it directly · 3 of its ownK030178 Calcigen Psi Bone Graft SubstituteBiomet, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK042305 Ossaplast Ortho, O.5ML, Model# 221 900, Ossaplast Ortho, 1.0ML…Ossacur AG · 2004
- Descendant · cites it directly · 2 of its ownK041616 Bgran Synthetic Osteoconductive ScaffoidOrthos (Uk) Limited · 2004
- Descendant · 2 generations on · 1 of its ownK083372 Arrowbone-a, Arrowbone-BBrainbase Corporation · 2009
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K050260Bioresorb Macro PoreOraltronics Dental Implant Technology GmbH · 2005 · cites it directly4descendants
- K030178Calcigen Psi Bone Graft SubstituteBiomet, Inc. · 2003 · cites it directly3descendants
- K042305Ossaplast Ortho, O.5ML, Model# 221 900, Ossaplast Ortho, 1.0ML, Model# 221 901…Ossacur AG · 2004 · cites it directly2descendants
- K041616Bgran Synthetic Osteoconductive ScaffoidOrthos (Uk) Limited · 2004 · cites it directly2descendants
- K083372Arrowbone-a, Arrowbone-BBrainbase Corporation · 2009 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K014156 | Cerasorb Ortho | Curasan AG | 2002 | — |
| +1 | K050260 | Bioresorb Macro Pore | Oraltronics Dental Implant Technology GmbH | 2005 | — |
| +1 | K030178 | Calcigen Psi Bone Graft Substitute | Biomet, Inc. | 2003 | — |
| +1 | K042305 | Ossaplast Ortho, O.5ML, Model# 221 900, Ossaplast Ortho, 1.0ML, Model# 221… | Ossacur AG | 2004 | — |
| +1 | K041616 | Bgran Synthetic Osteoconductive Scaffoid | Orthos (Uk) Limited | 2004 | — |
| +2 | K083372 | Arrowbone-a, Arrowbone-B | Brainbase Corporation | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 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 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? (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 |
|---|---|---|---|
| * | — | Vitoss™ Scaffold Named without a submission number |
What descends from it? (16)
See all 168 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050260 | Bioresorb Macro Pore | 2005 | 4 |
| K030178 | Calcigen Psi Bone Graft Substitute | 2003 | 3 |
| K042305 | Ossaplast Ortho, O.5ML, Model# 221 900, Ossaplast Ortho, 1.0ML, Model# 221 901… | 2004 | 2 |
| K041616 | Bgran Synthetic Osteoconductive Scaffoid | 2004 | 2 |
| K050416 | Ossaplast Ortho | 2005 | 1 |
| K032286 | Calcigen Psi Bone Graft Substitute | 2003 | 1 |
| K143692 | GranOSTM - beta tricalcium phosphate synthetic bone granules | 2015 | 0 |
| K100841 | Boneoptimizer | 2010 | 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, K050260 (Oraltronics Dental Implant Technology GmbH, 2005) has gone furthest, with 4 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 | — |
What is it indicated for?
Cerasorb ORTHO in granular form is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the hony structures. It is indicated for filling of bone defects, caused by surgery, trauma or degenerative process. Cerasorb ORTHO granules are intended to be gently packed into the bony voids or gaps of the skeletal system. The material should not be packed in dry form, it should be mixed with autologous bload (Wood…
Read the full statement (131 words)
Cerasorb ORTHO in granular form is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the hony structures. It is indicated for filling of bone defects, caused by surgery, trauma or degenerative process. Cerasorb ORTHO granules are intended to be gently packed into the bony voids or gaps of the skeletal system. The material should not be packed in dry form, it should be mixed with autologous bload (Wood from the void or venous blood). The implanted material must be in direct contact with the bleeding vital bone.
Cerasorb ORTHO granules have no weight-bearing capacity. Therefore, osteosynthetic measures may be required.
Following placement in the bony voids or gaps, the Beta-Tricalciumphosphate granules are gradually resorbed and. replaced with new bone.
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/K014156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014156: Cerasorb Ortho.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014156
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026