510(k) · Cleared
ClearedEovia Calcium Phosphate Ceramic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Tec, LLC · MQV Filler, Bone Void, Calcium Compound
Cleared on May 3, 2004 after a 66-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- May 3, 2004
- Review
- 66 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK040514 Eovia Calcium Phosphate CeramicOrtho Tec, LLC · 2004
- Descendant · cites it directly · 2 of its ownK082419 Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK101827 OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011
- Descendant · 3 generations on · 0 of its ownK213260 CMFlexTMDimension Inx Corp. · 2022
- Descendant · cites it directly · 0 of its ownK071121 Tribone 80Biomatlante · 2007
- Descendant · cites it directly · 0 of its ownK063527 MBCP+Biomatlante · 2007 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc. · 2009 · cites it directly2descendants
- K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011 · 2 generations on1descendant
- K213260CMFlexTMDimension Inx Corp. · 2022 · 3 generations on0descendants
- K071121Tribone 80Biomatlante · 2007 · cites it directly0descendants
- K063527MBCP+Biomatlante · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040514 | Eovia Calcium Phosphate Ceramic | Ortho Tec, LLC | 2004 | — |
| +1 | K082419 | Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1 | Intra-Lock International, Inc. | 2009 | — |
| +2 | K101827 | Osteoscaf | Texas Innovative Medical Devices (Dba) Skeletal | 2011 | — |
| +3 | K213260 | CMFlexTM | Dimension Inx Corp. | 2022 | — |
| +1 | K071121 | Tribone 80 | Biomatlante | 2007 | — |
| +1 | K063527 | MBCP+ | Biomatlante | 2007 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2022 | 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?
The FDA summary names no predicate by number.
What descends from it? (5)
3 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?
- Of its descendants, K082419 (Intra-Lock International, Inc., 2009) has gone furthest, with 2 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?
EOVIA Calcium Phosphate Ceramic is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. EOVIA Calcium Phosphate Ceramic is to be gently packed into bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. EOVIA Calcium Phosphate Ceramic provides a bone void filler that is resorbed and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040514: Eovia Calcium Phosphate Ceramic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040514
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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