510(k) · Cleared
ClearedCerament Bone Void Filler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bonesupport AB · MQV Filler, Bone Void, Calcium Compound
Cleared on Sep 28, 2005 as substantially equivalent to K024336 (Wrightmedicaltechnologyinc, 2003) and 5 other predicates after a 72-day review. Its family tree reaches back 4 generations to 1996. 10 later devices descend from it.
- Decided
- Sep 28, 2005
- Review
- 72 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K960978 (1996). 12 ancestors in all, the oldest K910432 (1991). 10 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 3 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 2 generations backK030131 Ossatura BCP Bone Void FillerIsotis NV · 2003
- 1 generation backK033722 Apapore Bone Graft SubstituteApatech, Ltd. · 2004
- This deviceK051951 Cerament Bone Void FillerBonesupport AB · 2005
- Descendant · cites it directly · 6 of its ownK073316 Cerament Bone Void Filler, Model A0210Bonesupport AB · 2008
- Descendant · 2 generations on · 3 of its ownK201535 Cerament Bone Void FillerBonesupport AB · 2020
- Descendant · 3 generations on · 2 of its ownK212083 Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK071004 Osteocrete Bone Void FillerBone Solutions, Inc. · 2009
- Descendant · 4 generations on · 1 of its ownK223915 TactosetAnika Therapeutics, Inc. · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K073316Cerament Bone Void Filler, Model A0210Bonesupport AB · 2008 · cites it directly6descendants
- K201535Cerament Bone Void FillerBonesupport AB · 2020 · 2 generations on3descendants
- K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc. · 2021 · 3 generations on2descendants
- K071004Osteocrete Bone Void FillerBone Solutions, Inc. · 2009 · cites it directly2descendants
- K223915TactosetAnika Therapeutics, Inc. · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −3 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −2 | K030131 | Ossatura BCP Bone Void Filler | Isotis NV | 2003 | — |
| −1 | K033722 | Apapore Bone Graft Substitute | Apatech, Ltd. | 2004 | — |
| 0 (this device) | K051951 | Cerament Bone Void Filler | Bonesupport AB | 2005 | — |
| +1 | K073316 | Cerament Bone Void Filler, Model A0210 | Bonesupport AB | 2008 | — |
| +2 | K201535 | Cerament Bone Void Filler | Bonesupport AB | 2020 | — |
| +3 | K212083 | Tactoset Injectable Bone Substitute | Anika Therapeutics, Inc. | 2021 | — |
| +1 | K071004 | Osteocrete Bone Void Filler | Bone Solutions, Inc. | 2009 | — |
| +4 | K223915 | Tactoset | Anika Therapeutics, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 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? (6)
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 |
|---|---|---|---|
| * | K024336 | Miig II Bone Graft SubstituteSummary page 1…ols per 21 CFR 8883045 PREDICATE DEVICES: 510(k) Number Trade or Proprietary or Model Name Manufacturer K024336 1 MIIG II ™ 1… | 2003 |
| * | K010532 | Osteoset BVF KitSummary page 1…er K024336 1 MIIG II ™ 1 Wright Medical Technology K010532 2 Osteoset BVF Kit 2… | 2001 |
| * | K022622 | Cem-Ostetic, Models Cemo-020O, Cemo-05P, Cemo-10P, Cemo-20P, and Cemo-30PSummary page 1…ogy K010532 2 Osteoset BVF Kit 2 Wright Medical Technology K022622 3 Cem-Ostetic™ 3… | 2003 |
| * | K023862 | Norian XR Calcium Phosphate Bone Void FillerSummary page 1…K022622 3 Cem-Ostetic™ 3 Berkley Advanced Biomaterials K023862 4 Norian® XR 4… | 2002 |
| * | K033722 | Apapore Bone Graft SubstituteSummary page 1…ced Biomaterials K023862 4 Norian® XR 4 Synthes Inc. K033722 5 ApaPore® 5… | 2004 |
| * | K961511 | Hapset Hydroxylapatite Bone Graft PlasterSummary page 1…Synthes Inc. K033722 5 ApaPore® 5 Apa Tech Limited K961511 6 Hapset 6… | 1996 |
What descends from it? (10)
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?
- The line of descent spans 9 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K073316 (Bonesupport AB, 2008) has gone furthest, with 6 descendants of its own.
- 6 other devices also cite its predicate K024336.
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?
Cerament™ is a ceramic bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Cerament™ is indicated to be injected into bony voids or gaps in the skeletal system, i.e. extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects from traumatic injury to the bone. Cerament™ provides a bone void filler that resorbs and is replaced by bone during the healing process
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051951 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051951: Cerament Bone Void Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051951
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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