510(k) · Cleared
ClearedPRO-DENSE LoVisc 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 Oct 21, 2020 as substantially equivalent to K181255 (Wrightmedicaltechnologyinc, 2018) and 2 other predicates after a 233-day review. Its family tree reaches back 12 generations to 2002. 1 later device descends from it.
- Decided
- Oct 21, 2020
- Review
- 233 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K013966 (2002). 35 ancestors in all, the oldest K994337 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
- 8 generations between
- 3 generations backK161568 Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. · 2016
- 2 generations backK181255 PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018
- 1 generation backK182823 PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018
- This deviceK200507 PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2020
- Descendant · cites it directly · 0 of its ownK213342 PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2022
Show all 12 generations
- Root · 12 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
- 11 generations backK022629 WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc · 2002
- 10 generations backK031817 Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc · 2003
- 9 generations backK043261 Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 2005 · Recalled
- 8 generations backK100754 Graft Delivery System Model SA-6115Micromedics, Inc. · 2010
- 7 generations backK111632 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011
- 6 generations backK121476 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012
- 5 generations backK133021 Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014
- 4 generations backK141245 Etex Mixing and Delivery SystemEtex Corporation · 2014
- 3 generations backK161568 Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. · 2016
- 2 generations backK181255 PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018
- 1 generation backK182823 PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018
- This deviceK200507 PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2020
Most influential descendants
Showing 1 of 1 · See all- K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K013966 | Apatight-TCP Bone Graft Substitute | Cerabio, LLC | 2002 | — |
| −11 | K022629 | WMT-TCP Bone Graft Substitute | Wrightmedicaltechnologyinc | 2002 | — |
| −10 | K031817 | Cellplex TCP Synthetic Cancellous Bone | Wrightmedicaltechnologyinc | 2003 | — |
| −9 | K043261 | Harvest Graft Delivery Syringe | Harvest Technologies, Corp. | 2005 | 2 |
| −8 | K100754 | Graft Delivery System Model SA-6115 | Micromedics, Inc. | 2010 | — |
| −7 | K111632 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2011 | — |
| −6 | K121476 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2012 | — |
| −5 | K133021 | Mixing Syringe System | Zimmer Knee Creations, Inc. | 2014 | — |
| −4 | K141245 | Etex Mixing and Delivery System | Etex Corporation | 2014 | — |
| −3 | K161568 | Bone Solutions Mixing and Delivery System | Bone Solutions, Inc. | 2016 | — |
| −2 | K181255 | PRODENSE Bone Graft Substitute | Wrightmedicaltechnologyinc | 2018 | — |
| −1 | K182823 | PRODENSE Bone Graft Substitute | Wrightmedicaltechnologyinc | 2018 | — |
| 0 (this device) | K200507 | PRO-DENSE LoVisc Bone Graft Substitute | Wrightmedicaltechnologyinc | 2020 | — |
| +1 | K213342 | PRO-DENSE LoVisc Bone Graft Substitute | Wrightmedicaltechnologyinc | 2022 | — |
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 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K181255 | PRODENSE Bone Graft SubstituteSummary page 4…ct Code & Panel: MQV – Orthopedic (a)(3) PREDICATE DEVICE INFORMATION PRO‐DENSE Bone Graft Substitute K181255/K182823 PROSTIM Injectable Inductive Graft K190283 (a)(4) DEVICE DESCRIPTON… | 2018 |
| * | K182823 | PRODENSE Bone Graft SubstituteSummary page 4…& Panel: MQV – Orthopedic (a)(3) PREDICATE DEVICE INFORMATION PRO‐DENSE Bone Graft Substitute K181255/K182823 PROSTIM Injectable Inductive Graft K190283 (a)(4) DEVICE DESCRIPTON PRO… | 2018 |
| * | K190283 | PROSTIM Injectable Inductive GraftSummary page 4…ON PRO‐DENSE Bone Graft Substitute K181255/K182823 PROSTIM Injectable Inductive Graft K190283 (a)(4) DEVICE DESCRIPTON PRO‐DENSE™ LoVisc Bone Graft Substitute is a composite of calcium sulfate and calcium… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213342 | PRO-DENSE LoVisc Bone Graft Substitute | 2022 | 0 |
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 18 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 35 ancestors have a recall of any class.
- Of its descendants, K213342 (Wrightmedicaltechnologyinc, 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K181255.
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. 2020, 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™ LoVisc Bone Graft Substitute 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…
Read the full statement (163 words)
PRO-DENSE™ LoVisc Bone Graft Substitute 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. PRO-DENSE™ LoVisc Bone Graft Substitute resorbs and is replaced with bone during the healing process.
PRO-DENSE™ LoVisc Bone Graft Substitute 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™ LoVisc Bone Graft Substitute is provided sterile for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200507 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200507: PRO-DENSE LoVisc Bone Graft Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200507
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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