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 Jan 5, 2022 as substantially equivalent to K200507 (Wrightmedicaltechnologyinc, 2020) after a 90-day review. Its family tree reaches back 13 generations to 2002.
- Decided
- Jan 5, 2022
- Review
- 90 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K013966 (2002). 36 ancestors in all, the oldest K994337 (2000). No later device cites it as a predicate yet.
- Root · 13 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
- 9 generations between
- 3 generations backK181255 PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018
- 2 generations backK182823 PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018
- 1 generation backK200507 PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2020
- This deviceK213342 PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2022
Show all 13 generations
- Root · 13 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
- 12 generations backK022629 WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc · 2002
- 11 generations backK031817 Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc · 2003
- 10 generations backK043261 Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 2005 · Recalled
- 9 generations backK100754 Graft Delivery System Model SA-6115Micromedics, Inc. · 2010
- 8 generations backK111632 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011
- 7 generations backK121476 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012
- 6 generations backK133021 Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014
- 5 generations backK141245 Etex Mixing and Delivery SystemEtex Corporation · 2014
- 4 generations backK161568 Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. · 2016
- 3 generations backK181255 PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018
- 2 generations backK182823 PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018
- 1 generation backK200507 PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2020
- This deviceK213342 PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K013966 | Apatight-TCP Bone Graft Substitute | Cerabio, LLC | 2002 | — |
| −12 | K022629 | WMT-TCP Bone Graft Substitute | Wrightmedicaltechnologyinc | 2002 | — |
| −11 | K031817 | Cellplex TCP Synthetic Cancellous Bone | Wrightmedicaltechnologyinc | 2003 | — |
| −10 | K043261 | Harvest Graft Delivery Syringe | Harvest Technologies, Corp. | 2005 | 2 |
| −9 | K100754 | Graft Delivery System Model SA-6115 | Micromedics, Inc. | 2010 | — |
| −8 | K111632 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2011 | — |
| −7 | K121476 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2012 | — |
| −6 | K133021 | Mixing Syringe System | Zimmer Knee Creations, Inc. | 2014 | — |
| −5 | K141245 | Etex Mixing and Delivery System | Etex Corporation | 2014 | — |
| −4 | K161568 | Bone Solutions Mixing and Delivery System | Bone Solutions, Inc. | 2016 | — |
| −3 | K181255 | PRODENSE Bone Graft Substitute | Wrightmedicaltechnologyinc | 2018 | — |
| −2 | K182823 | PRODENSE Bone Graft Substitute | Wrightmedicaltechnologyinc | 2018 | — |
| −1 | K200507 | PRO-DENSE LoVisc Bone Graft Substitute | Wrightmedicaltechnologyinc | 2020 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K200507 | PRO-DENSE LoVisc Bone Graft SubstituteSummary page 4…ice Product Code & Panel: MQV – Orthopedic PREDICATE DEVICE INFORMATION Primary : PRO-DENSE LoViscTM Bone Graft Substitute K200507 Reference: PRO-DENSETM Bone Graft Substitute K181255 DEVICE DESCRIPTON PRO-DENSE Lo… | 2020 |
| † | K181255 | PRODENSE Bone Graft Substitute | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 36 ancestors have a recall of any class.
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. 2022, 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™ resultant pastel 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 (161 words)
PRO-DENSE LoVisc™ resultant pastel 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 LoVisc™ 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 LoVisc™ is provided sterile for single use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213342: PRO-DENSE LoVisc 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/K213342
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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