510(k) · Cleared
ClearedCeraform Bone Void Filler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teknimed, S.A. · MQV Filler, Bone Void, Calcium Compound
Cleared on May 3, 2004 as substantially equivalent to K031826 (Teknimed, S.A., 2003) after a 49-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- May 3, 2004
- Review
- 49 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K994337 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK994337 Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita Co. · 2000
- 2 generations backK021963 Biosorb Resorbable Void FillerSciences ET Bio Materiaux (Sbm) · 2003 · Recalled
- 1 generation backK031826 TRIHA +Teknimed, S.A. · 2003 · Recalled
- This deviceK040669 Ceraform Bone Void FillerTeknimed, S.A. · 2004
- Descendant · cites it directly · 0 of its ownK042911 Cementek LVTeknimed, S.A. · 2004
Most influential descendants
Showing 1 of 1 · See all- K042911Cementek LVTeknimed, S.A. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void Filler | Orthovita Co. | 2000 | — |
| −2 | K021963 | Biosorb Resorbable Void Filler | Sciences ET Bio Materiaux (Sbm) | 2003 | 1 |
| −1 | K031826 | TRIHA + | Teknimed, S.A. | 2003 | 1 |
| 0 (this device) | K040669 | Ceraform Bone Void Filler | Teknimed, S.A. | 2004 | — |
| +1 | K042911 | Cementek LV | Teknimed, S.A. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K031826 | TRIHA +Summary page 1…Filler, calcium sulfate, preformed pellets per 21 CFR Sec. 888.3045 Equivalent Device Ceraform Bone Void Filler is a modification to Teknimed's TRIHA+ Bone Void Filler (K031826). Device Description Ceraform Bone Void Filler is an osseo-conductive macroporous implant made of synthetic beta tri-calcium pho… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042911 | Cementek LV | 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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K042911 (Teknimed, S.A., 2004) has gone furthest, with 0 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?
Ceraform Bone Void Filler is intended for use only as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Ceraform Bone Void Filler is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. Ceraform Bone Void Filler should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. Ceraform Bone…
Read the full statement (120 words)
Ceraform Bone Void Filler is intended for use only as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Ceraform Bone Void Filler is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. Ceraform Bone Void Filler should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Ceraform Bone Void Filler is intended to be gently packed into voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040669 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040669: Ceraform 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/K040669
Report an extraction error
Are you the manufacturer?
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