510(k) · Cleared
ClearedPRODENSE 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 Sep 12, 2018 as substantially equivalent to K113871 (Wrightmedicaltechnologyinc, 2013) and 2 other predicates after a 124-day review. Its family tree reaches back 10 generations to 2002. 7 later devices descend from it.
- Decided
- Sep 12, 2018
- Review
- 124 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K013966 (2002). 31 ancestors in all, the oldest K994337 (2000). 7 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
- 6 generations between
- 3 generations backK133021 Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014
- 2 generations backK141245 Etex Mixing and Delivery SystemEtex Corporation · 2014
- 1 generation backK161568 Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. · 2016
- This deviceK181255 PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018
- Descendant · cites it directly · 5 of its ownK182823 PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018
- Descendant · 2 generations on · 2 of its ownK212083 Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK190283 PROSTIM Injectable Inductive GraftWrightmedicaltechnologyinc · 2019
- Descendant · 3 generations on · 1 of its ownK223915 TactosetAnika Therapeutics, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK200507 PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2020
Show all 10 generations
- Root · 10 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
- 9 generations backK022629 WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc · 2002
- 8 generations backK031817 Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc · 2003
- 7 generations backK043261 Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 2005 · Recalled
- 6 generations backK100754 Graft Delivery System Model SA-6115Micromedics, Inc. · 2010
- 5 generations backK111632 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011
- 4 generations backK121476 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012
- 3 generations backK133021 Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014
- 2 generations backK141245 Etex Mixing and Delivery SystemEtex Corporation · 2014
- 1 generation backK161568 Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. · 2016
- This deviceK181255 PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K182823PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018 · cites it directly5descendants
- K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc. · 2021 · 2 generations on2descendants
- K190283PROSTIM Injectable Inductive GraftWrightmedicaltechnologyinc · 2019 · cites it directly2descendants
- K223915TactosetAnika Therapeutics, Inc. · 2023 · 3 generations on1descendant
- K200507PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2020 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K013966 | Apatight-TCP Bone Graft Substitute | Cerabio, LLC | 2002 | — |
| −9 | K022629 | WMT-TCP Bone Graft Substitute | Wrightmedicaltechnologyinc | 2002 | — |
| −8 | K031817 | Cellplex TCP Synthetic Cancellous Bone | Wrightmedicaltechnologyinc | 2003 | — |
| −7 | K043261 | Harvest Graft Delivery Syringe | Harvest Technologies, Corp. | 2005 | 2 |
| −6 | K100754 | Graft Delivery System Model SA-6115 | Micromedics, Inc. | 2010 | — |
| −5 | K111632 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2011 | — |
| −4 | K121476 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2012 | — |
| −3 | K133021 | Mixing Syringe System | Zimmer Knee Creations, Inc. | 2014 | — |
| −2 | K141245 | Etex Mixing and Delivery System | Etex Corporation | 2014 | — |
| −1 | K161568 | Bone Solutions Mixing and Delivery System | Bone Solutions, Inc. | 2016 | — |
| 0 (this device) | K181255 | PRODENSE Bone Graft Substitute | Wrightmedicaltechnologyinc | 2018 | — |
| +1 | K182823 | PRODENSE Bone Graft Substitute | Wrightmedicaltechnologyinc | 2018 | — |
| +2 | K212083 | Tactoset Injectable Bone Substitute | Anika Therapeutics, Inc. | 2021 | — |
| +1 | K190283 | PROSTIM Injectable Inductive Graft | Wrightmedicaltechnologyinc | 2019 | — |
| +3 | K223915 | Tactoset | Anika Therapeutics, Inc. | 2023 | — |
| +1 | K200507 | PRO-DENSE LoVisc Bone Graft Substitute | Wrightmedicaltechnologyinc | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 6 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K113871 | Pro-Dense Bone Graft SubstituteSummary page 4…MQV, Orthopedic FMF, General and Plastic Surgery (a)(3). Predicate Device: K113871 – PRODENSE™ Bone Graft Substitute… | 2013 |
| * | K072597 | Pro-Dense Core Decompression Procedure KitSummary page 4…K113871 – PRODENSE™ Bone Graft Substitute K072597 – PRODENSE™ Core Decompression Procedure Kit… | 2007 |
| * | K161568 | Bone Solutions Mixing and Delivery SystemSummary page 4…K072597 – PRODENSE™ Core Decompression Procedure Kit K161568 – Bone Solutions Mixing and Delivery System (a)(4). Device Description… | 2016 |
What descends from it? (7)
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?
- The line of descent spans 16 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 31 ancestors have a recall of any class.
- Of its descendants, K182823 (Wrightmedicaltechnologyinc, 2018) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K113871.
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. 2018, 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 (260 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.
For the PRO-DENSE™ Core Decompression Procedure Kit:
The PRO-DENSE™ 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-DENSE™ Core Decompression Procedure Kit is not intended to be used as a load-bearing device.
For the Mixing and Delivery System:
The Mixing and Delivery syringe is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181255: PRODENSE Bone Graft Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181255
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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