510(k) · Cleared
ClearedCementek LV
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 Dec 27, 2004 as substantially equivalent to K040669 (Teknimed, S.A., 2004) after a 67-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Dec 27, 2004
- Review
- 67 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K994337 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK994337 Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita Co. · 2000
- 3 generations backK021963 Biosorb Resorbable Void FillerSciences ET Bio Materiaux (Sbm) · 2003 · Recalled
- 2 generations backK031826 TRIHA +Teknimed, S.A. · 2003 · Recalled
- 1 generation backK040669 Ceraform Bone Void FillerTeknimed, S.A. · 2004
- This deviceK042911 Cementek LVTeknimed, S.A. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void Filler | Orthovita Co. | 2000 | — |
| −3 | K021963 | Biosorb Resorbable Void Filler | Sciences ET Bio Materiaux (Sbm) | 2003 | 1 |
| −2 | K031826 | TRIHA + | Teknimed, S.A. | 2003 | 1 |
| −1 | K040669 | Ceraform Bone Void Filler | Teknimed, S.A. | 2004 | — |
| 0 (this device) | K042911 | Cementek LV | Teknimed, S.A. | 2004 | — |
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 |
|---|---|---|---|
| * | K040669 | Ceraform Bone Void FillerSummary page 1…k® LV Common name: Bone void filler Classification name: Class II per 21 CFR section 888.3045 Product Code: MQV Equivalent Device: Cementek ® (K040669) Device Description As an injectable bone substitute, Cementek® LV is packaged as a solid phase and a liquid phase. The liquid a… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 4 ancestors have a recall of any class.
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?
Cementek® LV is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Cementek® LV is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. The putty can be injected into the bony voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, Cementek® LV resorbs and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042911: Cementek LV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042911
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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