510(k) · Cleared
ClearedExactech Resorbable Room Temperature Bone Paste
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Jun 17, 2004 as substantially equivalent to K020078 (Exactech, Inc., 2004) after an 85-day review. Its family tree reaches back 2 generations to 1997. 16 later devices descend from it.
- Decided
- Jun 17, 2004
- Review
- 85 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K963562 (1997). 4 ancestors in all. 16 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK963562 Wright Plaster of Paris PelletsWrightmedicaltechnologyinc · 1997
- 1 generation backK020078 Exactech Resorbable Bone PasteExactech, Inc. · 2004
- This deviceK040755 Exactech Resorbable Room Temperature Bone PasteExactech, Inc. · 2004
- Descendant · cites it directly · 10 of its ownK043048 Grafton Plus DBM PasteOsteotech, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 9 of its ownK060794 Progenix DBM Putty and PasteMedtronic Sofamor Danek · 2006
- Descendant · 3 generations on · 4 of its ownK072265 Progenix DMB PuttyMedtronic Sofamor Danek · 2008
- Descendant · 3 generations on · 3 of its ownK132868 CarricellEtex Corporation · 2015
- Descendant · cites it directly · 3 of its ownK050806 OptecureExactech, Inc. · 2006
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K043048Grafton Plus DBM PasteOsteotech, Inc. · 2005 · cites it directly10descendants
- K060794Progenix DBM Putty and PasteMedtronic Sofamor Danek · 2006 · 2 generations on9descendants
- K072265Progenix DMB PuttyMedtronic Sofamor Danek · 2008 · 3 generations on4descendants
- K132868CarricellEtex Corporation · 2015 · 3 generations on3descendants
- K050806OptecureExactech, Inc. · 2006 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963562 | Wright Plaster of Paris Pellets | Wrightmedicaltechnologyinc | 1997 | — |
| −1 | K020078 | Exactech Resorbable Bone Paste | Exactech, Inc. | 2004 | — |
| 0 (this device) | K040755 | Exactech Resorbable Room Temperature Bone Paste | Exactech, Inc. | 2004 | — |
| +1 | K043048 | Grafton Plus DBM Paste | Osteotech, Inc. | 2005 | 15 |
| +2 | K060794 | Progenix DBM Putty and Paste | Medtronic Sofamor Danek | 2006 | — |
| +3 | K072265 | Progenix DMB Putty | Medtronic Sofamor Danek | 2008 | — |
| +3 | K132868 | Carricell | Etex Corporation | 2015 | — |
| +1 | K050806 | Optecure | Exactech, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2008 | 5 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K020078 | Exactech Resorbable Bone PasteSummary page 1…ed Devices for Substantial Equivalence Comparison: Product Code Manufacturer 510(k) Number Product MQV, MBP Exactech Inc. K020078 Exactech Resorbable Bone Paste 4. Comparison to the Predicate Device(s): Exactech Resorbable Room Temperature… | 2004 |
What descends from it? (16)
See all 163 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 7 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K043048 (Osteotech, Inc., 2005) has gone furthest, with 10 descendants of its own.
- 7 other devices also cite its predicate K020078.
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?
Exactech Resorbable Bone Paste is intended for use as a bone graft extender (extremities, spine, pelvis) and as a bone void filler for bony voids or gaps of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Exactech Resorbable Bone Paste may be used with rigid fixation systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040755: Exactech Resorbable Room Temperature Bone Paste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040755
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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