510(k) · Cleared
ClearedPro-Dense Bone Graft Substitute
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 Mar 25, 2013 as substantially equivalent to K070437 (Wrightmedicaltechnologyinc, 2007) after a 451-day review. Its family tree reaches back 2 generations to 2006. 11 later devices descend from it.
- Decided
- Mar 25, 2013
- Review
- 451 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K060011 (2006). 11 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK060011 Miig SRWrightmedicaltechnologyinc · 2006
- 1 generation backK070437 Pro-Dense Bone Void FillerWrightmedicaltechnologyinc · 2007
- This deviceK113871 Pro-Dense Bone Graft SubstituteWrightmedicaltechnologyinc · 2013
- 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 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · 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) | K113871 | Pro-Dense Bone Graft Substitute | Wrightmedicaltechnologyinc | 2013 | — |
| +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 |
| 2024 | 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 |
|---|---|---|---|
| * | K070437 | Pro-Dense Bone Void FillerSummary page 1…Salt Bone Void Filler Device - Class 11 Device Product Code and Panel Code: Orthopedic/87/MQV Predicate Device: K070437 - PRO-DENSE® Bone Graft Substitute DEVICE INFORMATION A. INTENDED USE PRO-DENSE® resultant paste is intended for use as a bone… | 2007 |
What descends from it? (11)
See all 113 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 1 company; a new generation was cleared every 5.9 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. 2013, 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?
PRO-DENSE® resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients > 6 years old), surgically created osseous defects or osseous defects created from…
Read the full statement (158 words)
PRO-DENSE® resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients > 6 years old), surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
The PRO-DENSE® paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
PRO-DENSE® is provided sterile for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113871 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113871: Pro-Dense Bone Graft Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113871
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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