510(k) Report

510(k) · Cleared

Cleared

Pro-Dense Bone Void Filler

K070437510(k) SpecialCleared May 9, 200783-day reviewClass II21 CFR 888.3045

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wrightmedicaltechnologyinc · MQV Filler, Bone Void, Calcium Compound

Cleared on May 9, 2007 as substantially equivalent to K060011 (Wrightmedicaltechnologyinc, 2006) after an 83-day review. Its family tree reaches back 1 generation to 2006. 15 later devices descend from it.

Decided
May 9, 2007
Review
83 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K060011 (2006). 15 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2012: 1 descendant cleared2007: 1 descendant cleared2014: 2 descendants cleared2018: 2 descendants cleared2021: 2 descendants cleared2024: 1 descendant cleared2019: 1 descendant cleared2020: 1 descendant cleared2022: 1 descendant cleared2023: 2 descendants clearedK060011 · Miig SR · Wrightmedicaltechnologyinc · 200620052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants5 generations forward: 2 descendants K060011 · Miig SR · Wrightmedicaltechnologyinc · 20060+5
  1. Root · 1 generation backK060011 Miig SRWrightmedicaltechnologyinc · 2006
  2. This deviceK070437 Pro-Dense Bone Void FillerWrightmedicaltechnologyinc · 2007
  3. Descendant · cites it directly · 11 of its ownK113871 Pro-Dense Bone Graft SubstituteWrightmedicaltechnologyinc · 2013
  4. Descendant · cites it directly · 10 of its ownK072597 Pro-Dense Core Decompression Procedure KitWrightmedicaltechnologyinc · 2007
  5. Descendant · 2 generations on · 7 of its ownK181255 PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018
  6. Descendant · 3 generations on · 5 of its ownK182823 PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018
  7. Descendant · 4 generations on · 2 of its ownK212083 Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc. · 2021

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2007: 12012: 12013: 12014: 22018: 22019: 12020: 12021: 22022: 12023: 22024: 1
2007high 2 (2014) · low 0 (2008)2026

Most influential descendants

Showing 5 of 15 · See all
  • K113871Pro-Dense Bone Graft SubstituteWrightmedicaltechnologyinc · 2013 · cites it directly11descendants
  • K072597Pro-Dense Core Decompression Procedure KitWrightmedicaltechnologyinc · 2007 · cites it directly10descendants
  • K181255PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018 · 2 generations on7descendants
  • K182823PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018 · 3 generations on5descendants
  • K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc. · 2021 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K060011Miig SRWrightmedicaltechnologyinc2006—
0 (this device)K070437Pro-Dense Bone Void FillerWrightmedicaltechnologyinc2007—
+1K113871Pro-Dense Bone Graft SubstituteWrightmedicaltechnologyinc2013—
+1K072597Pro-Dense Core Decompression Procedure KitWrightmedicaltechnologyinc2007—
+2K181255PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc2018—
+3K182823PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc2018—
+4K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201210
201310
201420
201820
201910
202010
202120
202210
202320
202410
FIG. 1 — Lineage of K070437, 2006–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K232315 Catalyst Bone Void Fillerscore 25.2 · 25 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K060011Miig SR
Summary page 2
…elf life, and design features of the PRO-DENSETM Bone Graft Substitute are substantially equivalent to the previously cleared MIIG® SR Bone Void Filler 510(k): K06001 1. Additionally, the safety and effectiveness of the PRO-DENSETM Bone Graft Substitute is adequately supported by the substant…
Wrightmedicaltechnologyinc2006—

Also cleared against K060011: 1 other device →

What descends from it? (15)

See all 15

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K113871Pro-Dense Bone Graft SubstituteWrightmedicaltechnologyinc201311
K072597Pro-Dense Core Decompression Procedure KitWrightmedicaltechnologyinc200710
K112383Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) Bone Void FillerSkeletal Kinetics, LLC20121

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?

  • Its one ancestor has no recall.
  • Of its descendants, K113871 (Wrightmedicaltechnologyinc, 2013) has gone furthest, with 11 descendants of its own.
  • 1 other device also cites its predicate K060011.

How does its category compare?

All MQV devices

MQV 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

2007: 352008: 322009: 232010: 172011: 162012: 92013: 122014: 202015: 182016: 82017: 172018: 232019: 132020: 152021: 82022: 92023: 212024: 282025: 142026 (partial year): 5
2007high 35 (2007) · low 8 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQV

57in 2025

2007: 144 days median2008: 102 days median2009: 180 days median2010: 147 days median2011: 92 days median2012: 107 days median2013: 197 days median2014: 153 days median2015: 184 days median2016: 214 days median2017: 124 days median2018: 124 days median2019: 90 days median2020: 132 days median2021: 88 days median2022: 118 days median2023: 74 days median2024: 55 days median2025: 57 days median2026 (partial year): 96 days median
2007high 214 (2016) · low 55 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQV

1in 2025

2007: 52008: 32009: 12011: 62012: 32013: 22016: 12017: 12018: 22020: 12023: 32024: 22025: 12026 (partial year): 4
2007high 6 (2011) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQV

57in 2025

2007: 672008: 712009: 812010: 682011: 1142012: 1492013: 2232014: 1112015: 1252016: 1062017: 1072018: 862019: 652020: 1262021: 1012022: 472023: 1202024: 682025: 57
2007high 223 (2013) · low 47 (2022)2025

MAUDE reports naming product code MQV, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735144567
200832102371
200923180181
201017147068
201116926114
201291073149
2013121972223
2014201530111
2015181840125
201682141106
2017171241107
201823124286
20191390065
2020151321126
20218880101
20229118047
202321743120
20242855268
20251457157
20265964—

What is it indicated for?

PRO-DENSETM 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, spine, and pelvis) to cure in-situ. These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs…

Read the full statement (140 words)

PRO-DENSETM 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, spine, and pelvis) to cure in-situ. These open bone voids may be 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-DENSETM 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-DENSM .TMis provided sterile for single use only.

Indications for use as stated in the FDA summary.

Also cleared against K060011

1 other device cites the same predicate.

  • K112383Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) Bone Void FillerSkeletal Kinetics, LLC · 20123 recalls

More from Wrightmedicaltechnologyinc

311 FDA decisions under this applicant name. See the company

  • K222835Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2023
  • K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2022
  • K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2021
  • K202815PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2021
  • K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc · 2021

Recent decisions in MQV

The MQV category page

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  • K260364Device 300419 StripGeistlich Pharma AG · 2026
  • K252797JAZBI™ Resorbable Bone Void FillerSdip Innovations Pty, Ltd. · 2026
  • K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute…Stryker Spine · 2026
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https://510kreport.com/device/K070437 · printed Nov 5, 2026

Cite this page

510(k) Report. “K070437: Pro-Dense Bone Void Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070437

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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