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 Oct 16, 2020 as substantially equivalent to K073316 (Bonesupport AB, 2008) after a 130-day review. Its family tree reaches back 6 generations to 1996. 3 later devices descend from it.
- Decided
- Oct 16, 2020
- Review
- 130 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K960978 (1996). 14 ancestors in all, the oldest K910432 (1991). 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 5 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 4 generations backK030131 Ossatura BCP Bone Void FillerIsotis NV · 2003
- 3 generations backK033722 Apapore Bone Graft SubstituteApatech, Ltd. · 2004
- 2 generations backK051951 Cerament Bone Void FillerBonesupport AB · 2005
- 1 generation backK073316 Cerament Bone Void Filler, Model A0210Bonesupport AB · 2008
- This deviceK201535 Cerament Bone Void FillerBonesupport AB · 2020
- Descendant · cites it directly · 2 of its ownK212083 Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK223915 TactosetAnika Therapeutics, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK231968 Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −5 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −4 | K030131 | Ossatura BCP Bone Void Filler | Isotis NV | 2003 | — |
| −3 | K033722 | Apapore Bone Graft Substitute | Apatech, Ltd. | 2004 | — |
| −2 | K051951 | Cerament Bone Void Filler | Bonesupport AB | 2005 | — |
| −1 | K073316 | Cerament Bone Void Filler, Model A0210 | Bonesupport AB | 2008 | — |
| 0 (this device) | K201535 | Cerament Bone Void Filler | Bonesupport AB | 2020 | — |
| +1 | K212083 | Tactoset Injectable Bone Substitute | Anika Therapeutics, Inc. | 2021 | — |
| +2 | K223915 | Tactoset | Anika Therapeutics, Inc. | 2023 | — |
| +1 | K231968 | Tactoset® Injectable Bone Substitute | 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 |
|---|---|---|
| 2021 | 1 | 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? (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 |
|---|---|---|---|
| * | K073316 | Cerament Bone Void Filler, Model A0210Summary page 5…n be drilled and screws can be placed through it. Predicate Devices 510(k) Trade name Manufacturer Predicate number K073316 CERAMENTBONE VOID FILLER Bonesupport AB Primary predicate CERAMENTBONE VOID FILLE… | 2008 |
| † | K090871 | Cerament Ibone Void Filler High Contrast, Model a 0210-12 | 2009 |
| † | K132656 | Prodense Bone Graft Substitute | 2014 |
| † | K113871 | Pro-Dense Bone Graft Substitute | 2013 |
| † | K102722 | Norian Drillable Inject, Norian Drillable Fast Set Putty | 2011 |
What descends from it? (3)
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 24 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K212083 (Anika Therapeutics, Inc., 2021) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K073316.
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. 2020, this device’s year, is highlighted.
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 | BONE VOID FILLER is a ceramic bone graft substitute intended for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. CERAMENT | BONE VOID FILLER is indicated to be injected, or placed, into bony voids or gaps in the skeletal system, i.e. extremities, pelvis, and posterolateral spine (only during open surgery in spine). These defects may be the result of benign bone cysts and…
Read the full statement (171 words)
CERAMENT | BONE VOID FILLER is a ceramic bone graft substitute intended for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.
CERAMENT | BONE VOID FILLER is indicated to be injected, or placed, into bony voids or gaps in the skeletal system, i.e. extremities, pelvis, and posterolateral spine (only during open surgery in spine). These defects may be the result of benign bone cysts and tumors (in adults and pediatric patients > 9 years old), or osseous defects created as a result of either surgery or traumatic injury to the bone.
CERAMENT | BONE VOID FILLER resorbs and is replaced by bone during the healing process.
CERAMENT | BONE VOID FILLER can augment hardware and support bone fragments during the surgical procedure.
The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process. CERAMENT | BONE VOID FILLER can be drilled and screws can be placed through it.
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/K201535 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201535: Cerament Bone Void Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201535
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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