510(k) · Cleared
ClearedPro-Dense Core Decompression Procedure Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · MQV Filler, Bone Void, Calcium Compound
Cleared on Oct 15, 2007 as substantially equivalent to K070437 (Wrightmedicaltechnologyinc, 2007) after a 31-day review. Its family tree reaches back 2 generations to 2006. 10 later devices descend from it.
- Decided
- Oct 15, 2007
- Review
- 31 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K060011 (2006). 10 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK060011 Miig SRWrightmedicaltechnologyinc · 2006
- 1 generation backK070437 Pro-Dense Bone Void FillerWrightmedicaltechnologyinc · 2007
- This deviceK072597 Pro-Dense Core Decompression Procedure KitWrightmedicaltechnologyinc · 2007
- Descendant · cites it directly · 7 of its ownK181255 PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018
- Descendant · 2 generations on · 5 of its ownK182823 PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018
- Descendant · 3 generations on · 2 of its ownK212083 Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc. · 2021
- Descendant · 2 generations on · 2 of its ownK190283 PROSTIM Injectable Inductive GraftWrightmedicaltechnologyinc · 2019
- Descendant · 4 generations on · 1 of its ownK223915 TactosetAnika Therapeutics, Inc. · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K181255PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018 · cites it directly7descendants
- K182823PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018 · 2 generations on5descendants
- K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc. · 2021 · 3 generations on2descendants
- K190283PROSTIM Injectable Inductive GraftWrightmedicaltechnologyinc · 2019 · 2 generations on2descendants
- K223915TactosetAnika Therapeutics, Inc. · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K060011 | Miig SR | Wrightmedicaltechnologyinc | 2006 | — |
| −1 | K070437 | Pro-Dense Bone Void Filler | Wrightmedicaltechnologyinc | 2007 | — |
| 0 (this device) | K072597 | Pro-Dense Core Decompression Procedure Kit | Wrightmedicaltechnologyinc | 2007 | — |
| +1 | K181255 | PRODENSE Bone Graft Substitute | Wrightmedicaltechnologyinc | 2018 | — |
| +2 | K182823 | PRODENSE Bone Graft Substitute | Wrightmedicaltechnologyinc | 2018 | — |
| +3 | K212083 | Tactoset Injectable Bone Substitute | Anika Therapeutics, Inc. | 2021 | — |
| +2 | K190283 | PROSTIM Injectable Inductive Graft | Wrightmedicaltechnologyinc | 2019 | — |
| +4 | K223915 | Tactoset | Anika Therapeutics, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K070437 | Pro-Dense Bone Void FillerSummary page 1…he PRO-DENSETM Core Decompression Procedure Kit are substantially equivalent to the design features of the PRO-DENSE Bone Void Filler submission (510(k): K070437). The implant material of the PRO-DENSETM Core Decompression Procedure Kit is exactly the same as the predicate above. Th… | 2007 |
What descends from it? (10)
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 1 year and passes through 1 company; a new generation was cleared every 1.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K181255 (Wrightmedicaltechnologyinc, 2018) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K070437.
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. 2007, 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?
The PRO-DENSETM Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the PRO-DENSETM Core Decompression Procedure Kit is not intended to be used as a load-bearing device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072597 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072597: Pro-Dense Core Decompression Procedure Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072597
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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